Clinical trial NCT01430286: Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients
Official title: Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Caregivers
Alzheimer Disease
Psychological stress
Psychological adaptation
Self-efficacy
Randomized controlled trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Direction de l'Hospitalisation et de l'Organisation des Soins (PREQHOS)
name: Fondation Mederic Alzheimer
First posted: 2011-09-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Perceived stress
timeFrame: every 3 months (between 0 and 6 months)
Secondary outcomes:
measure: Nottingham Health Profile (NPH)
timeFrame: every 3 months (between 0 and 6 months)
measure: ZARIT Burden Interview (BI)
timeFrame: every 3 months (between 0 and 6 months)
measure: Revised Memory and Behavior Problems Checklist (RMBPC)
timeFrame: every 3 months (between 0 and 6 months)
measure: Beck Depression Inventory (BDI-2)
timeFrame: every 3 months (between 0 and 6 months)
measure: Revised Scale for Caregiving Self-Efficacy (RCSE)
timeFrame: every 3 months (between 0 and 6 months)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic
Study officials:
affiliation: Hôpital Broca - la Collégiale, Memory Clinic
name: Anne-Sophie Rigaud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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