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

NCT ID: NCT01430286

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psycho-educational program

This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.

Group Type: EXPERIMENTAL

psycho-social intervention based on a web-based psycho-educational program, called Diapason.

Intervention Type: BEHAVIORAL

This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.

Standard treatment

This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation.

Group Type: ACTIVE_COMPARATOR

Consultation in memory clinic

Intervention Type: BEHAVIORAL

This group will receive treatment as usual (consultation in memory clinic every 6 months)

Interventions

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.

Intervention Type: BEHAVIORAL

Consultation in memory clinic

This group will receive treatment as usual (consultation in memory clinic every 6 months)

Intervention Type: BEHAVIORAL

Other Intervention Names

Web-based psycho-educational program

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

UNKNOWN

Sponsor Role: collaborator

Fondation Mederic Alzheimer

OTHER

Sponsor Role: collaborator

URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Sophie Rigaud, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Broca - la Collégiale, Memory Clinic

Locations

Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic

Paris, , France

Countries

France

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Other Identifiers

P081002

Identifier Type: -

Identifier Source: org_study_id