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

March 16, 2018 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
every 3 months (between 0 and 6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Nottingham Health Profile (NPH)
Time Frame: every 3 months (between 0 and 6 months)
every 3 months (between 0 and 6 months)
ZARIT Burden Interview (BI)
Time Frame: every 3 months (between 0 and 6 months)
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)
every 3 months (between 0 and 6 months)
Beck Depression Inventory (BDI-2)
Time Frame: every 3 months (between 0 and 6 months)
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)
every 3 months (between 0 and 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Fondation Mederic Alzheimer
Direction de l'Hospitalisation et de l'Organisation des Soins (PREQHOS)

Investigators

  • Principal Investigator: Anne-Sophie Rigaud, MD, PhD, Hôpital Broca - la Collégiale, Memory Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 22, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P081002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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