Home-Based Respiratory Physiotherapy and Telephone-Based Psychological Support for COVID-19 Survivors in Peru: Protocol for a Randomized Controlled Trial

Background Both pulmonary and mental health are affected following hospitalization for COVID-19 pneumonia. Pulmonary rehabilitation therapy has demonstrated benefits in improving mental health, but no validated combined programs that include mental health have been proposed. Objective This article presents the design of a trial that aimed to assess whether the participation in a combined rehabilitation program that includes home-based respiratory physiotherapy and telephone-based psychological support is associated with a greater improvement of pulmonary and mental health outcomes 7-12 weeks after COVID-19 hospitalization discharge compared with posthospital usual care provided by a public Peruvian hospital. Methods WAYRA (the word for air in the Quechua language) was an open-label, unblinded, two-arm randomized controlled trial. We recruited 108 participants aged 18-75 years who were discharged from the hospital after COVID-19 pneumonia that required >6 liters/minute of supplemental oxygen during treatment. Participants were randomly assigned at a 1:1 ratio to receive the combined rehabilitation program or usual posthospital care provided by a public Peruvian hospital. The intervention consisted of 12 at-home respiratory rehabilitation sessions and 6 telephone-based psychological sessions. The primary outcome was the 6-minute walk distance. Secondary outcomes included lung function, mental health status (depression, anxiety, and trauma), and quality of life. Outcomes were assessed at baseline (before randomization) and at 7 and 12 weeks after hospital discharge to assess the difference between arms. Results This study was funded by the Peruvian National Council of Science Technology and Technology Innovation in July 2020. Ethics approval was obtained on September 2, 2020. Recruitment and data collection occurred between October 2020 and June 2021. Results are expected to be published by the end of 2022. Conclusions WAYRA was the first randomized controlled trial evaluating combined pulmonary-mental health rehabilitation for hospitalized COVID-19 survivors in resource-limited settings, potentially providing a foundation for the cost-effective scale-up of similar multidisciplinary rehabilitation programs. Trial Registration ClinicalTrials.gov NCT04649736; https://clinicaltrials.gov/ct2/show/NCT04649736 International Registered Report Identifier (IRRID) RR1-10.2196/36001


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "telephone-based psychological support" Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "telephone-based psychological support" 1a-iii) Primary condition or target group in the title Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "COVID-19 survivors " Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The intervention consisted of twelve at-home respiratory rehabilitation sessions and six telephone-based psychological sessions" Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This part is not relevant to the study, because it is explained in the body of the manuscript.
1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-iii? Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "open-label, unblinded, two-arm randomized controlled trial" 1b-iv) RESULTS section in abstract must contain use data Does your paper address subitem 1b-iv?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We recruited 108 participants aged 18-75 years who were discharged from the hospital after COVID-19 pneumonia that required >6 L/min of supplemental oxygen during treatment" Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Considering that COVID-19 is a disease that results in short-, medium-and long-term physical and mental impairment and that limited rehabilitation strategies have been evaluated, this manuscript describes the design and methodology of a randomized controlled trial that aimed to evaluate the effects of integrated home-based respiratory physiotherapy combined with a telephone-based psychological intervention on pulmonary and mental health-related outcomes at 7 and 12 weeks after hospital discharge in patients with COVID-19 pneumonia. The primary objective of the trial was to compare 6-minute walk distances at 7 and 12 weeks after hospital discharge for COVID-19 pneumonia in participants of a combined 6-week home-based respiratory physiotherapy and telephonebased psychological rehabilitation program versus those who received usual care practices."

RELLENAR
Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The primary objective of the trial was to compare 6-minute walk distances at 7 and 12 weeks after hospital discharge for COVID-19 pneumonia in participants of a combined 6week home-based respiratory physiotherapy and telephone-based psychological rehabilitation program versus those who received usual care practices."

RELLENAR
Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "WAYRA (air in Quechua) was a randomized, controlled, open-label, two-arm clinical trial that evaluated the efficacy of a six-week home-based respiratory physiotherapy and telephonebased psychological program compared to conventional post-hospitalization care, aimed at improving exercise tolerance, lung function, mental health, and QoL outcomes. A baseline assessment was conducted at hospital discharge, with two follow-ups at week 7 and 12 ( Figure 1). Due to the nature of the rehabilitation interventions, blinding of participants and the researchers was not possible; however, the data scientist conducted the data analysis was blinded. We used a blinded list pre-uploaded in REDcap [17] which was created by a data administrator who was not involved in study recruitment. To achieve balance in the number of participants assigned to each study arm, the treatment arm was randomized in a 1:1 ratio using permuted blocks of variable size, randomly varying from 2, 4 and 6 participants. The blocks were randomized using Stata v16.0's ralloc command (StataCorp, College Station, TX, 2016)." Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study population consisted of confirmed cases of COVID-19, diagnosed by serological or molecular tests, including members of both sexes, between 18 and 75 years of age, discharged from hospitalization, who received high flow oxygen (>6 L/min) treatment at any point during hospitalization. Participants with prior respiratory pathology or psychiatric diagnoses were excluded. We list complete eligibility criteria in Table 1"

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.  4b) Settings and locations where the data were collected Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A trained nurse made the initial contact and pre-screening, starting with a daily review of the list of hospitalized patients during the enrollment period, to identify potentially eligible participants among newly discharged patients or those close to discharge in the following days. Potential participants were informed about the study, its procedures and were invited to participate. Those who accepted received a detailed explanation of the nature of the study, randomization, study procedures, their potential risks and benefits, their rights as participants and the study timelines. Potential subjects were explicitly told that participation was not mandatory, that there was no penalty for refusing to participate, and that their clinical treatment at the hospital would not be compromised in any way if they refuse to participate or opt out of the study at any time. All interested patients received the screening informed consent form (Supplemental Material 3) for their review, and they provided a signature once all their questions and concerns were addressed." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "This study was conducted in the COVID-19 ward at Hospital Nacional Cayetano Heredia (HNCH), a public tertiary care hospital and a major referral center that serves approximately 3 million people from underserved neighborhoods in the northern metropolitan area of Lima, Peru's capital. HNCH was one of the main COVID-19 national referral centers throughout the pandemic, with 241 hospitalization beds and 23 ICU beds [14]. During the pandemic, more than half of Lima´s population reported depressive symptoms, with increased rates of symptoms reported among young people with low income and without higher education [15]." Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. subitem not at all important 1 2 3 4 5 essential 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.

RELLENAR
Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "For mental health and quality of life assessments, participants responded to questionnaires administered by a trained health worker. We used PHQ-9, GAD-7, and IES-R questionnaires to assess mental health including depression [25], anxiety[26] and post-traumatic stress disorder symptoms [27], respectively. Mental health questionnaires were administered at 2, 4, 7, 8 and 12 weeks after hospitalization by telephone home calls ( Figure 1B). We used the SF-36 v2 [28] and EQ-5D [29] questionnaires to measure quality of life at 7 and 12 weeks after discharge. The psychometric properties of the SF-36 questionnaire have been widely studied and consist of 36 items assessing 8 dimensions: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role and mental health [30]. The details of the measurements for the primary and secondary outcomes are summarized in Table 2. We used the Saint George Respiratory Questionnaire to measure respiratory symptoms, an instrument recommended to measuring changes in respiratory health following interventions[31]. We measured respiratory symptoms at 7 and 12 weeks after hospital discharge." Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript Does your paper address subitem 5-i? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The authors declare that no competing interests exist."

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b). Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability Does your paper address subitem 5-x? Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable. Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta.

5-xi) Report any prompts/reminders used
RELLENAR UNA RESPUESTA NUEVA Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The primary health outcome was the change in six-minute walk distance (6MWD) at 7 and 12 weeks after discharge compared to baseline ( Figure 1B) Figure 1B, we show the outcome assessment schedule." "A trained physician measured forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio using a portable spirometer (Easy-On-PC, ndd, Zurich, Switzerland). These spirometers are frequently used in pulmonary research because their calibration remains stable over time [23]. We aimed to obtain at least three acceptable and two reproducible tests following joint recommendations of the American Thoracic Society and European Respiratory Societies[24] or until the participant was no longer able to tolerate the procedure. Results were recorded on a secure interface (EasyOnConnect, ndd, Zurich, Switzerland) on a personal computer." "For mental health and quality of life assessments, participants responded to questionnaires administered by a trained health worker. We used PHQ-9, GAD-7, and IES-R questionnaires to assess mental health including depression [25] Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We used STATA Version 16 (StataCorp, Texas, USA) to calculate the ideal sample size. We attempted to enroll 108 participants in total, allocating 54 to each treatment arm. We estimate that a sample size of 86 participants would be able to detect a mean difference between arms of 55.1 meters in 6MWD according to the study by Liu et al [11] considering a 95% confidence level and 90% power. Assuming a potential 20% rate of rejection or loss to follow-up, we aim to achieve a sample of 108 participants."

RELLENAR
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "There will be no formal interim analysis of the data." Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We used a blinded list pre-uploaded in REDcap [17] which was created by a data administrator who was not involved in study recruitment. To achieve balance in the number of participants assigned to each study arm, the treatment arm was randomized in a 1:1 ratio using permuted blocks of variable size, randomly varying from 2, 4 and 6 participants. The blocks were randomized using Stata v16.0's ralloc command (StataCorp, College Station, TX, 2016). Finally, all participants were scheduled for follow-up visits as described in the Figure 1B. Sample selection and enrolment took place between the day before hospital discharge and up to three days after discharge."

RELLENAR
Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We used a blinded list pre-uploaded in REDcap [17] which was created by a data administrator who was not involved in study recruitment. To achieve balance in the number of participants assigned to each study arm, the treatment arm was randomized in a 1:1 ratio using permuted blocks of variable size, randomly varying from 2, 4 and 6 participants. The blocks were randomized using Stata v16.0's ralloc command (StataCorp, College Station, TX, 2016). Finally, all participants were scheduled for follow-up visits as described in the Figure 1B. Sample selection and enrolment took place between the day before hospital discharge and up to three days after discharge." Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We used a blinded list pre-uploaded in REDcap [17] which was created by a data administrator who was not involved in study recruitment. To achieve balance in the number of participants assigned to each study arm, the treatment arm was randomized in a 1:1 ratio using permuted blocks of variable size, randomly varying from 2, 4 and 6 participants. The blocks were randomized using Stata v16.0's ralloc command (StataCorp, College Station, TX, 2016). Finally, all participants were scheduled for follow-up visits as described in the Figure 1B. Sample selection and enrolment took place between the day before hospital discharge and up to three days after discharge." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We used a blinded list pre-uploaded in REDcap [17] which was created by a data administrator who was not involved in study recruitment." Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Due to the nature of the rehabilitation interventions, blinding of participants and the researchers was not possible; however, the data scientist conducted the data analysis was blinded."

RELLENAR
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Same answer as above Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "We will conduct an intention-to-treat analysis of primary and secondary outcomes at 7-and 12-weeks after hospital discharge. The final analysis will be performed when all 108 participants completed the trial. We will compare the 6MWD (meters), FVC (liters), FEV1 (liters) and questionnaire scores at 7 and 12 weeks after hospitalization discharge between intervention and control arms. In the secondary analyses, we will compare the proportion of participants with restrictive spirometry pattern, depression, anxiety, and PSTD at 7-and 12weeks after hospital discharge between intervention and control arms. In addition, following the recommendation by Cocks and Torgerson, we will use a one-sided 80% confidence interval to determine if this trial should proceed to a phase III trial [32]. As a sensitivity analysis, the association between the number of therapies received and outcomes will be examined, adjusting for potential confounders that will be identify by a causal acyclic diagram. There will be no formal interim analysis of the data."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4] Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "As a sensitivity analysis, the association between the number of therapies received and outcomes will be examined, adjusting for potential confounders that will be identify by a causal acyclic diagram." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A trained nurse made the initial contact and pre-screening, starting with a daily review of the list of hospitalized patients during the enrollment period, to identify potentially eligible participants among newly discharged patients or those close to discharge in the following days. Potential participants were informed about the study, its procedures and were invited to participate. Those who accepted received a detailed explanation of the nature of the study, randomization, study procedures, their potential risks and benefits, their rights as participants and the study timelines. Potential subjects were explicitly told that participation was not mandatory, that there was no penalty for refusing to participate, and that their clinical treatment at the hospital would not be compromised in any way if they refuse to participate or opt out of the study at any time. All interested patients received the screening informed consent form (Supplemental Material 3) for their review, and they provided a signature once all their questions and concerns were addressed."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "To protect participant's confidentiality, all collected data of clinical assessments were linked to a unique ID code. Data were registered in paper form and electronically. The electronic information was stored, backed-up and secured by password protection in the RedCap server. Paper forms were archived in secure locked cabinets in the HNCH. All confidential information, including participant's contact details or other sensible data, was only accessible to authorized staff from the project. Long-term data management complied with UPCH research policy." "Both control and intervention arm participants benefited from the study. These benefits included education and counseling on respiratory disease risk factors, reporting of pulmonary function test results by a specialist physician, and referral to trained personnel if necessary." "Potential risks of respiratory rehabilitation were oxygen desaturation, palpitations, sweating, arrhythmias, chest tightness, shortness of breath, and muscle aches. Potential risks of psychological support were symptom substitution, dependence on the physiotherapist, stigmatization, problems in social relationships or even separation, as well as alcohol or drug abuse, deliberate self-harm and suicidal ideation or attempts. Adverse events of the interventions were collected after subjects gave informed consent and were duly enrolled in the study. If adverse events were detected, the field staff immediately notified the study coordinator and the management protocol was activated." Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

RELLENAR
Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other gures or tables demonstrating usage/dose/engagement. Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The trial ended within the intended time period Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

16-i) Report multiple "denominators" and provide definitions
Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a). Does your paper address subitem 17a-i?

RELLENAR
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "WAYRA is the first randomized controlled trial evaluating integrated pulmonary and mental health rehabilitation for hospitalized COVID-19 survivors in a low-and middle-income country setting. Through this trial we gained experience in implementing a remote rehabilitation program in a resource-limited country and generated evidence on pulmonary, mental health and quality of life alterations following COVID-19 the first three months after hospitalization. We hypothesize that the participation on the combined program will improve pulmonary, physical, and mental health outcomes. We hope that our study will provide a reliable basis for further clinical trials focused on comprehensive rehabilitation in patients hospitalized for severe COVID-19 and other lung diseases."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The main strength of this study is that the calculated sample size has the power to detect a clinically significant difference between the groups. On the other hand, this study has some limitations to be considered. First, mental health and quality of life outcomes will be assessed with screening tools. Second, this trial has an open-label design due the nature of intervention."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations B o r r a r s e l e c c i ó n Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.

RELLENAR
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The trial was registered at ClinicalTrials.gov (NCT04649736).
Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Not applicable.
As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
Tu respuesta Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta. How much time did you spend on going through the checklist INCLUDING making changes in your manuscript Estás editando tu respuesta. Si compartes esta URL, otros usuarios también podrán editar la respuesta.

RELLENAR
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