Evaluating the Efficacy of a Web-Based Program (Diapason) for Informal Caregivers of Patients With Alzheimer’s Disease: Protocol for a Randomized Clinical Trial

Background Informal caregivers (CGs) of patients with Alzheimer’s disease are at risk of suffering from psychological and physical weakening. Several psychoeducational interventions have been designed to prevent stress and burden of caregivers. In France, despite health authorities’ recommendations, to our knowledge there is no rigorously assessed Web-based psychoeducational program to date. Objective The objective of our study was to assess the efficacy of a French Web-based psychoeducational program (called Diapason) with an unblinded randomized clinical trial. Methods In this protocol, 80 informal caregivers of patients followed at Broca Hospital are recruited offline and randomized in the experimental condition (EC) or the control condition (CC). The volunteers in EC have to visit a closed online user group at least once a week and validate one new session of this fully automated Web program, during 12 weeks. Each week a new thematic is added to the website. The participants in the CC receive usual care, and have access to the Diapason program after their participation (6 months). Face-to-face evaluations for both groups are planned every 3 months (M0–M3 and M6). The main objective of this program is to provide CGs with information on the disease process, how to prevent psychological strain (using anticipation and relaxation techniques), and offering a virtual space (forum) to discuss with other caregivers. The primary outcome of this study is the self-perceived stress, while self-efficacy, burden, depression, and self-perceived health status are defined as secondary outcomes. Other variables that might have an impact on the program efficacy are collected. Results This protocol was accepted for funding. The enrollment began in October 2011, and participants currently recruited will finish their evaluations in January 2014. The results are expected for June 2014. Conclusions Findings might provide empirical evidence on: (1) the feasibility of an Internet-based program in the French context, (2) the effectiveness of a Web-based program for informal caregivers, and (3) the identification of caregivers who will benefit from this type of intervention. Trial Registration Clinicaltrials.gov NCT01430286; http://clinicaltrials.gov/ct2/show/NCT01430286 (Archived by WebCite at http://www.webcitation/6KxHaRspL).

"In this study 80 informal caregivers of patients followed at Broca Hospital are recruited offline and randomized in the experimental condition (EC) ...".In this study the assessments (visits) are conducted in face-to-face by an experienced psychologist in research protocols.'Face-to-face evaluations for both groups are planned every 3 months (M0 -M3 and M6)." "Assessing the efficacy of a French web-based psycho-educational program (called Diapason) with an unblinded randomized clinical trial was the aim of..." 1b-iv) RESULTS section in abstract must contain use data It is an ongoing protocol.Results are not available yet.1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials INTRODUCTION 2a-i) Problem and the type of system/solution "CGs are submitted to high levels of stress, and are at higher risk of weakening mental and physical health, lower life expectancy and lesser economic security than people who are not confronted to such stressful situations" "There are many reasons for caregivers to use or to prefer a distance intervention instead of a face-to-face one.(...) Finally, some of them live in remote regions, and other CGs do not feel at ease with face-to-face interventions or prefer a flexible time/content intervention " 2a-ii) Scientific background, rationale: What is known about the (type of) system "There are many reasons for caregivers to use or to prefer a distance intervention instead of a face-to-face one.(...) Finally, some of them live in remote regions, and other CGs do not feel at ease with face-to-face interventions or prefer a flexible time/content intervention [7].""Distance interventions, i.e. based on Information and Communications Technology (ICT) appeared in the earlier part of 21st century in order to propose an alternative intervention to caregivers unable to access health centers delivering face-to-face programs.Distant programs have shown a positive effect on self-perceived stress, burden, depression symptoms, and social support of caregivers.In the case of caregivers of patients with dementia, several websites exist in France, but these programs have not been, to our knowledge, subjected to a randomized clinical trial."METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "The purpose of this article is to present the study protocol of a randomized clinical trial designed to evaluate the efficacy of Diapason, a web-based psychoeducational program for caregivers of patients with Alzheimer's disease (AD).Our hypothesis is that the Diapason program reduces the caregiver's perceived stress and burden and enhances his/her self-efficacy and self-perceived health."3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons No, we did not change the method after trial commencement.3b-i) Bug fixes, Downtimes, Content Changes 4a) CONSORT: Eligibility criteria for participants "Eligible participants are informal French-speaking caregivers (family or not, providing care to the patient during 4 hours or more a week) of an AD patient diagnosed in the memory center of the Broca hospital, Paris, France, and who fulfills the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV [18]) or National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) criteria [19].To be included in the trial, caregivers have to be aged 18 or over to be able to provide an informed consent, to score 12 or over on the Perceived Stress Scale of 14 items (PSS-14 [20]) during screening and to have a computer with an internet access at home with an email address regularly used.If participants (CGs) are on psychopharmacological treatment or therapy, they are required to keep the same treatment at least two months before inclusion in the protocol."4a-i) Computer / Internet literacy In elibility criteria: "...and to have a computer with an internet access at home with an email address regularly used."4a-ii) Open vs. closed, web-based vs. face-to-face assessments: This is a closed face-to-face protocol: "The participants are recruited either during the follow-up consultation of a patient a) the geriatrician/neurologist delivers the general information about the protocol and gives a contact form to fill in and drop off at the memory center's reception desk or b) the CGs fill in the contact form available in the waiting room and drop it off at the memory center's reception desk.One of the two research psychologists previously trained in the protocol 4a-iii) Information giving during recruitment 4b) CONSORT: Settings and locations where the data were collected "Data are collected via an electronic case-report form (e-CRF) are centralized and store on a secured server using "CleanWEB" system " 4b-i) Report if outcomes were (self-)assessed through online questionnaires "When the participant delivers a positive answer, the first visit (M0) at the hospital is scheduled together with the psychologist.The duration of each visit (M0-M3 and M6) is estimated to 90 minutes.""Satisfaction towards the program content (weekly paper-based survey filled at home)" "6.The participants randomized in the EC receive the material (weekly paper -based survey, a journey book and a user's manual of the website)..." 4b-ii) Report how institutional affiliations are displayed 5) CONSORT: Describe the interventions for each group with sufficient details to allow replication, including how and when they were actually administered 5-i) Mention names, credential, affiliations of the developers, sponsors, and owners 5-ii) Describe the history/development process 5-iii) Revisions and updating 5-iv) Quality assurance methods 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used 5-vi) Digital preservation Yes it does: "Broca Hospital Team, Moulin F, De Rotrou J, Batrancourt B, Cristancho-Lacroix V, Wrobel J, Legouverneur G, El Haj M, Rigaud AS.Website Diapason: Comprendre et agir ensemble pour retrouver mon équilibre 2011.http://www.etreaudiapason.com/.www.webcitation.org/6JtmmPcHq"5-vii) Access "Diapason is a free password-protected web-site.The program is run in twelve thematic weekly sessions organized in the following order:" "The participants are recruited either during the follow-up consultation of a patient a) the geriatrician/neurologist delivers the general information about the protocol and gives a contact form to fill in and drop off at the memory center's reception desk or b) the CGs fill in the contact form available in the waiting room and drop it off at the memory center's reception desk.One of the two research psychologists previously trained in the protocol contacts the caregiver, checks his/her eligibility criteria and explains the benefits, constraints, and schedule of the protocol.The psychologist gives an information notice to the caregiver and proposes to contact him/her a few days later.If the caregiver agrees with the protocol and meets the criteria for inclusion, the screening session (M0) is scheduled with the caregiver."5-viii) Mode of delivery, features/functionalities/components of the intervention and comparator, and the theoretical framework "Diapason is a web-based version of a psycho-educational program, inspired by the group intervention sessions from the geriatric service of Broca Hospital called AIDMA program.AIDMA was assessed in a previous study including 167 dyads "patient-caregiver" and showed a significant improvement in disease understanding and in ability to cope with care-recipients' disease.""The Diapason program is an adapted computerized version of a psycho-educational program -AIDMA-created by the Geriatric Service of Broca Hospital.
Diapason is a free password-protected web-site.The program is run in twelve thematic weekly sessions organized in the following order" 5-ix) Describe use parameters

5-x) Clarify the level of human involvement
Report any prompts/reminders used The website offer online feedback (at the website).It indicates to each participant the of session(s) that should be validated.
We use external reminders only when the participant is clearly late to validate the sessions (3 weeks or more).In these cases the participant is called by a psychologist.
Finally, the psychologist calls each participant to remind him/her the next appointment some days before the visit.5-xii) Describe any co-interventions (incl.training/support) Both groups, experimental control "receive usual care.It consists in a follow-up appointment during which the caregiver obtains illness information from the geriatrician.(...)Every participant (A/N. in both groups) is advised to look for more specific help (i.e. that of a psychologist or a physician) when he/she feels it necessary and then to report it to the main investigator."6a) CONSORT: Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed "The duration of each visit (M0-M3 and M6) is estimated to 90 minutes.The baseline visit is usually conducted as follows: 1.The research psychologist answers the questions on information notice and the participant signs the informed consent if he/she agrees.2.Evaluation with PSS-14 (primary outcome).3.Randomization if PPS-14 total score is 12 or over.4.Demographical interview and control questions of caregiver's and patient's variables.5.Assessment of secondary variables (researcher-administered, and then self-administered surveys).6.The participants randomized in the EC receive the material (weekly paper -based survey, a journey book and a user's manual of the website) and a personal access-code to the website.Then, they are trained on how to use the web-based program.7.The CC participants are notified that they will receive a website access at the end of their participation to this protocol (six months after M0).8.Planning follow-up visits (M3 -M6).For the CC and EC groups, the assessments M3 and M6 visits are similar, and go as follows: first, evaluation of caregiver variables (time spent on caregiving, use of respite resources, stressful events, etc.) and patient status (hospitalization or other unexpected event occurred in the last three months).Then, measurements with self-administered scales or administered by an interviewer.The measures used in this RCT are summarized in Table 1." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed 6a-ii) Describe whether how "use" intensity of use/dosage) was defined/measured/monitored Yes, we will obtain the website statistics of use by participant and by period (M0-M3/ M3-M6).6a-iii) Describe whether, how, and when qualitative feedback from participants was 6b) CONSORT: changes to trial outcomes after the trial commenced, with Not, did not.7a) How sample size was determined 7a-i) Describe whether and expected attrition was taken into account when calculating the sample size 7b) CONSORT: When applicable, explanation of any interim analyses and stopping guidelines N/A 8a) Method used to generate random allocation sequence "Randomization: A computer-generated randomization list used to assign the participants in the condition (EC) group or in the control condition (CC) group after assessment with PSS-14 and all the inclusion and noninclusion criteria checked."8b) CONSORT: Type of randomisation; details of any restriction (such as blocking and block size) "Blocking and stratification gender and relationship (spouses vs. non spouses) were used to generate the randomization list."9) CONSORT: Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the interventions were assigned "A computer-generated randomization list is used to assign participants in the experimental condition group or in the control condition (CC) group after assessment with PSS-14 and all the inclusion and non-inclusion criteria checked."10) CONSORT: Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions The random allocation list is computer-generated.The participants are enrolled by the physicians.The participants are assigned to the interventions by a trained research psychologist who also conducts the evaluations: "One of the two research psychologists previously trained in the protocol contacts the caregiver, checks his/her eligibility criteria and explains the benefits, constraints, and schedule of the protocol.The psychologist gives an information notice to the caregiver and proposes to contact him/her a few days later.If the caregiver agrees with the protocol and meets the criteria for inclusion, the screening session (M0) is scheduled with the caregiver."11a) CONSORT: Blinding -If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who this protocol it was not possible to conduct a blind evaluation.Indeed, at the end of the first visit M0, the assessor give to the participants randomized the experimental group a training about how to use the website, then shows how to fulfill a paper-based questionnaire about their satisfaction program.In addition, the assessors have to control the assiduity of experimental group on the website.11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" 11b) CONSORT: If relevant, description of the similarity of interventions Not relevant for 12a) CONSORT: Statistical methods used to compare groups for primary and secondary outcomes of the characteristics two groups will be performed using percentages categorical variables and means with deviation for quantitative variables.For primary and outcomes, student t-tests or Wilcoxon test if required, as well as covariance analysis to take the regression to the mean into account, will be used to compare means between experimental and control groups.Percentages will be compared using Chi-Square test, or Fisher's exact test if required.Calculations will be performed using SAS software." 12a-i) Imputation techniques to deal with attrition / missing values the will be conducted to the intention to treat principle and handle missing data, multiple imputation will be used if the missing at random or missing completely at random hypothesis holds."12b) CONSORT: Methods for additional analyses, such as subgroup analyses and adjusted analyses "Percentages be compared using Chi-Square test, or Fisher's exact test if required."13a) CONSORT: For each group, the numbers of participants who randomly received intended treatment, and were analysed for the primary outcome It is an ongoing protocol.Results are not available yet.13b) CONSORT: For each group, and exclusions after randomisation, together with reasons It is an ongoing protocol.Results are not available yet.13b-i) Attrition diagram 14a) CONSORT: Dates defining the periods of recruitment and follow-up enrollment began in October 2011, and participants currently recruited finish their evaluations January 2014.The results are expected for June 2014."14a-i) Indicate if critical "secular events" fell into the study period 14b) CONSORT: Why trial ended or was stopped (early) N/A.It is an ongoing protocol.15) CONSORT: A table showing baseline demographic and clinical characteristics for each group It is an ongoing protocol.The results are expected for June 2014.15-i) Report demographics associated with digital divide issues It is an ongoing protocol.This item is not available yet.16a) CONSORT: For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups 16-i) Report multiple "denominators" and provide definitions It is ongoing protocol.This item is not available yet.16-ii) Primary analysis should be intent-to-treat 17a) CONSORT: For each primary and secondary outcome, results for each group, and the estimated effect size and its (such as 95% confidence interval) It is an ongoing protocol.This item is not available yet.17a-i) Presentation of process outcomes such as metrics of use and intensity of use 17b) CONSORT: For binary outcomes, presentation of both absolute and relative effect sizes is recommended It is an protocol.item is not available yet.18) CONSORT: Results of any performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory It is an protocol.This item is not available yet.18-i) Subgroup analysis of comparing only 19) All important harms or effects group It is ongoing protocol.This item is not available yet.19-i) privacy breaches, technical problems 19-ii) Include qualitative feedback from participants or observations from staff/researchers DISCUSSION 20) CONSORT: Trial limitations, addressing sources of potential imprecision, multiplicity of analyses 20-i) Typical limitations in ehealth trials The limitations of this trial: -It is not blinded.
-assessments for the baseline and the follow-ups at the hospital reduce the pertinence of this web-based program for some of volunteers who cannot come to the visits.
-Probably an individual support via the website added to this program would improve its impact.21) CONSORT: Generalisability (external validity, applicability) of the trial findings 21-i) Generalizability to other populations It is an ongoing protocol.This item is not available 21-ii) if there were elements in the RCT that would be different in a routine application setting