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

Alzheimer Disease Clinical Trial

— DIAPASON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430286
• Other study ID #: P081002
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: March 16, 2018
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Direction de l’Hospitalisation et de l’Organisation des Soins (PREQHOS), Fondation Médéric Alzheimer

Country where clinical trial is conducted

France, 

References & Publications (25)

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McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. — View Citation

Mittelman MS, Roth DL, Haley WE, Zarit SH. Effects of a caregiver intervention on negative caregiver appraisals of behavior problems in patients with Alzheimer's disease: results of a randomized trial. J Gerontol B Psychol Sci Soc Sci. 2004 Jan;59(1):P27-34. — View Citation

Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, Mountain G, O'Connell M, Harrison J, Vasse E, Dröes RM, Orrell M; INTERDEM group. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health. 2008 Jan;12(1):14-29. doi: 10.1080/13607860801919850. — View Citation

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	every 3 months (between 0 and 6 months)
Secondary	Nottingham Health Profile (NPH)		every 3 months (between 0 and 6 months)
Secondary	ZARIT Burden Interview (BI)		every 3 months (between 0 and 6 months)
Secondary	Revised Memory and Behavior Problems Checklist (RMBPC)		every 3 months (between 0 and 6 months)
Secondary	Beck Depression Inventory (BDI-2)		every 3 months (between 0 and 6 months)
Secondary	Revised Scale for Caregiving Self-Efficacy (RCSE)		every 3 months (between 0 and 6 months)