Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients (DIAPASON)
|ClinicalTrials.gov Identifier: NCT01430286|
Recruitment Status : Completed
First Posted : September 8, 2011
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: psycho-social intervention based on a web-based psycho-educational program, called Diapason. Behavioral: Consultation in memory clinic||Not Applicable|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||July 2014|
U.S. FDA Resources
Experimental: Psycho-educational program
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.
This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
Other Name: Web-based psycho-educational program
Active Comparator: Standard treatment
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
This group will receive treatment as usual (consultation in memory clinic every 6 months)
- Perceived stress [ Time Frame: every 3 months (between 0 and 6 months) ]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).
- Nottingham Health Profile (NPH) [ Time Frame: every 3 months (between 0 and 6 months) ]
- ZARIT Burden Interview (BI) [ Time Frame: every 3 months (between 0 and 6 months) ]
- Revised Memory and Behavior Problems Checklist (RMBPC) [ Time Frame: every 3 months (between 0 and 6 months) ]
- Beck Depression Inventory (BDI-2) [ Time Frame: every 3 months (between 0 and 6 months) ]
- Revised Scale for Caregiving Self-Efficacy (RCSE) [ Time Frame: every 3 months (between 0 and 6 months) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430286
|Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic|
|Paris, France, 75013|
|Principal Investigator:||Anne-Sophie Rigaud, MD, PhD||Hôpital Broca - la Collégiale, Memory Clinic|