Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients (DIAPASON)
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
psycho-social intervention based on a web-based psycho-educational program, called Diapason.
Consultation in memory clinic
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer Disease focused on measuring Caregivers, Alzheimer Disease, Psychological stress, Psychological adaptation, Self-efficacy, Randomized controlled trial
Eligibility Criteria
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
Sites / Locations
- Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Psycho-educational program
Standard treatment
Arm Description
This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Nottingham Health Profile (NPH)
ZARIT Burden Interview (BI)
Revised Memory and Behavior Problems Checklist (RMBPC)
Beck Depression Inventory (BDI-2)
Revised Scale for Caregiving Self-Efficacy (RCSE)
Full Information
NCT ID
NCT01430286
First Posted
August 22, 2011
Last Updated
March 16, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Direction de l'Hospitalisation et de l'Organisation des Soins (PREQHOS), Fondation Mederic Alzheimer
1. Study Identification
Unique Protocol Identification Number
NCT01430286
Brief Title
Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients
Acronym
DIAPASON
Official Title
Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Direction de l'Hospitalisation et de l'Organisation des Soins (PREQHOS), Fondation Mederic Alzheimer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Caregivers, Alzheimer Disease, Psychological stress, Psychological adaptation, Self-efficacy, Randomized controlled trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psycho-educational program
Arm Type
Experimental
Arm Description
This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation.
Intervention Type
Behavioral
Intervention Name(s)
psycho-social intervention based on a web-based psycho-educational program, called Diapason.
Other Intervention Name(s)
Web-based psycho-educational program
Intervention Description
This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
Intervention Type
Behavioral
Intervention Name(s)
Consultation in memory clinic
Intervention Description
This group will receive treatment as usual (consultation in memory clinic every 6 months)
Primary Outcome Measure Information:
Title
Perceived stress
Description
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).
Time Frame
every 3 months (between 0 and 6 months)
Secondary Outcome Measure Information:
Title
Nottingham Health Profile (NPH)
Time Frame
every 3 months (between 0 and 6 months)
Title
ZARIT Burden Interview (BI)
Time Frame
every 3 months (between 0 and 6 months)
Title
Revised Memory and Behavior Problems Checklist (RMBPC)
Time Frame
every 3 months (between 0 and 6 months)
Title
Beck Depression Inventory (BDI-2)
Time Frame
every 3 months (between 0 and 6 months)
Title
Revised Scale for Caregiving Self-Efficacy (RCSE)
Time Frame
every 3 months (between 0 and 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie Rigaud, MD, PhD
Organizational Affiliation
Hôpital Broca - la Collégiale, Memory Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
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Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients
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