Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients

Study Overview
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Brief Summary
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The aim of the project is to evaluate the efficacy of a web-based psycho-educational programme designed to support informal caregivers of patients with Alzheimer's disease (AD).This program focuses on information about the illness, her progression, how to prevent psychological strain using anticipation and relaxation techniques and providing a virtual space (forum) to discuss with other caregivers.

Detailed Description
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Context: Since some of the ICs do not have the possibility to participate in face-to-face interventions, information and communication technologies are being increasingly used for a distance intervention. Research showing the benefit of a combined approach including psycho-social interventions for caregivers and Information and Communication Technologies (ICT) in the caring of Alzheimer's disease patients is actually growing. Main objective: To evaluate the efficacy of a a web-based psycho-educational program designed to support carers of AD patientsMethodology: This is a randomized clinical trial . 80 participants will be randomized in 2 parallel groups: The volunteers in the experimental condition (EC) should visit at least one time per week the website of program, during 12 weeks. Each week a new thematic is added to the website. b) The participants in the control group (CG) will receive a minimal intervention, and will have access to the Diapason program after their participation (six months). Caregivers are recruited (according to exclusion and inclusion criteria) and followed up in memory center participating in the trial. Evaluation criteria: Primary criteria: - Perceived Stress Scale (PSS-14). Secondary evaluation criteria: Nottingham Health Profile (NPH), Zarit Burden Interview (BI), Revised Memory and Behavior Problems Checklist (RMBPC), Beck Depression Inventory (BDI-2) Mediator variables Revised Scale for Caregiving Self-Efficacy (RCSE). Statistics of website utilization Controlled variables Sociodemographic variables (Self report) Knowledge about illness (Visual analogical scale - VAS) The quality of the relationship with the patient (VAS) Time spent on caregiving Other sources of stress (i.e. work, health status, financial status) Respite or social help (i.e. psychotherapy, associations, technical help, etc) Cognitive and autonomy status of patient (MMSE and IADL) Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.

Official Title
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Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason.
* Behavioral: Consultation in memory clinic


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Family caregivers of AD patients DSM IV-TR (American Psychiatric Association 2004) or NINCDS/ADRDA (McKhann et al. 1984). Age: over 18 years old score 12 or over on the Perceived Stress Scale 14 items (PSS-14, Cohen) Need for information or help Sign informed consent Exclusion criteria : Professional or paid caregiver Physical or mental disease incompatible with patient's management Impossibility to participate in the educational program Absence of perceived stress Ongoing psychotherapy or a similar program in parallel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psycho-educational program<br>This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc. | Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason.<br>* This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.<br>* Other names: Web-based psycho-educational program;|
| Active Comparator: Standard treatment<br>This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation. | Behavioral: Consultation in memory clinic<br>* This group will receive treatment as usual (consultation in memory clinic every 6 months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived stress | Stress perceived by the caregiver is measured by the French version of the Perceived Stress Scale, the version of 14 items from Cohen and colleagues (1983), traduced to by Bruchon-Schweitzer in 2002. The PSS-14 is a widely used self-reported scale, evaluating the general appraisal of stress in the last month. It consists in 14 items, which scores range from 0 (never) to 4 (very often). This scale has demonstrated a high reliability and validity in several studies. The total score range is 0-56. In this study CG and EC will perform the scale at baseline (month 0), at the end of intervention for EC (month 3) and follow-up (month 6). Participants from control group will receive an acces to the program at the end of the last visit (M6). | every 3 months (between 0 and 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nottingham Health Profile (NPH) |  | every 3 months (between 0 and 6 months) | 
| ZARIT Burden Interview (BI) |  | every 3 months (between 0 and 6 months) | 
| Revised Memory and Behavior Problems Checklist (RMBPC) |  | every 3 months (between 0 and 6 months) | 
| Beck Depression Inventory (BDI-2) |  | every 3 months (between 0 and 6 months) | 
| Revised Scale for Caregiving Self-Efficacy (RCSE) |  | every 3 months (between 0 and 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregivers, Alzheimer Disease, Psychological stress, Psychological adaptation, Self-efficacy, Randomized controlled trial