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

Purpose

The aim of the project is to demonstrate that a web-based psycho-educational program designed to support carers of Alzheimer's disease (AD) patients induces a significantly decreased perceived stress related to caregiving. This program focuses on the explanation/description of behavioral, cognitive and functional disorders induced by the disease, as well as principles of stress mechanisms and ways of coping with a stressful situation.

Condition	Intervention
Alzheimer Disease	Behavioral: Web-based psycho-educational program Behavioral: Consultation in memory clinic

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Contribution of a Web-based Psycho-Educational Program Designed to Support Carers of Alzheimer's Disease (AD) Patients

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Caregivers Memory

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Perceived stress [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
Score on Perceived Stress Scale (PSS-14; Cohen et al, 1983) at baseline (month 0), end of intervention (month 3) and follow-up (month 6).

Secondary Outcome Measures:

Nottingham Health Profile (NPH) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
ZARIT Burden Interview (BI) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
Revised Memory and Behavior Problems Checklist (RMBPC) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
Beck Depression Inventory (BDI-2) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]
Revised Scale for Caregiving Self-Efficacy (RCSE) [ Time Frame: every 3 months (between 0 and 6 months) ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	October 2011
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Psycho-educational program This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.	Behavioral: Web-based psycho-educational program 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) Other Name: Consultation in memory clinic

Detailed Description:

Context: 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. We venture the hypothesis that a web-based psycho-educational program for the caregivers has a benefit on their level of stress. Main objective: to demonstrate that a web-based psycho-educational program designed to support carers of Alzheimer's disease (AD) patients induces a significantly decreased perceived stress and distress related to the patient's behavioural and psychological symptoms in dementia (BPSD), as well as improves their perceived health.

Methodology: randomized trial, with 2 parallel groups of 40 caregivers: (i) the first group is trained for a 3 month period; (ii) the second group receives treatment as usual (consultation in memory clinic every 6 months). 3 assessments are performed: at baseline (month 0), just after the training period (month 3) and 3 months after the training period (month 6). 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) - Revised Scale for Caregiving Self-Efficacy (RCSE).Statistical analysis by the department of biostatistics and medical computing of the Hospital Cochin will be performed.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Perceived stress related to patient's disease (PSS ≥ 12)
Need for information or help
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430286

Contacts

Contact: Anne-SophieRigaud Rigaud, MD, PhD	+ 33 (0) 1 44 08 35 03	anne-sophie.rigaud@brc.aphp.fr
Contact: Raphaël Serreau, MD, PhD	+33 (0) 1 58 41 11 80

Locations

France
Hôpital Broca - la Collégiale, Memory Clinic	Recruiting
Paris, France, 75013
Principal Investigator: Anne-SophieRigaud Rigaud, MD, PhD

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

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

Fondation Médéric Alzheimer

Investigators

Principal Investigator:

Anne-Sophie Rigaud, MD, PhD

Hôpital Broca - la Collégiale, Memory Clinic

More Information

Publications:

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Bourgeois MS, Schulz R, Burgio L. Interventions for caregivers of patients with Alzheimer's disease: a review and analysis of content, process, and outcomes. Int J Aging Hum Dev. 1996;43(1):35-92. Review.

Brodaty H, Green A, Koschera A. Meta-analysis of psychosocial interventions for caregivers of people with dementia. J Am Geriatr Soc. 2003 May;51(5):657-64.

Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

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Gallagher-Thompson D, Coon DW. Evidence-based psychological treatments for distress in family caregivers of older adults. Psychol Aging. 2007 Mar;22(1):37-51. Review.

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Livingston G, Manela M, Katona C. Depression and other psychiatric morbidity in carers of elderly people living at home. BMJ. 1996 Jan 20;312(7024):153-6.

Lyketsos CG, Steinberg M, Tschanz JT, Norton MC, Steffens DC, Breitner JC. Mental and behavioral disturbances in dementia: findings from the Cache County Study on Memory in Aging. Am J Psychiatry. 2000 May;157(5):708-14.

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.

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Magnusson L, Hanson E, Brito L, Berthold H, Chambers M, Daly T. Supporting family carers through the use of information and communication technology--the EU project ACTION. Int J Nurs Stud. 2002 May;39(4):369-81. Review.

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.

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.

Ramaroson H, Helmer C, Barberger-Gateau P, Letenneur L, Dartigues JF; PAQUID. [Prevalence of dementia and Alzheimer's disease among subjects aged 75 years or over: updated results of the PAQUID cohort]. Rev Neurol (Paris). 2003 Apr;159(4):405-11. French.

Schulz R, O'Brien AT, Bookwala J, Fleissner K. Psychiatric and physical morbidity effects of dementia caregiving: prevalence, correlates, and causes. Gerontologist. 1995 Dec;35(6):771-91. Review.

Schulz R, Beach SR. Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. JAMA. 1999 Dec 15;282(23):2215-9.

Schulz R, Martire LM, Klinger JN. Evidence-based caregiver interventions in geriatric psychiatry. Psychiatr Clin North Am. 2005 Dec;28(4):1007-38, x. Review. No abstract available.

Sörensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. Review.

Teri L. Behavior and caregiver burden: behavioral problems in patients with Alzheimer disease and its association with caregiver distress. Alzheimer Dis Assoc Disord. 1997;11 Suppl 4:S35-8. Review.

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Yesavage JA. Geriatric depression scale: consistency of depressive symptoms over time. Percept Mot Skills. 1991 Dec;73(3 Pt 1):1032. No abstract available.

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Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01430286 History of Changes
Other Study ID Numbers:	P081002
Study First Received:	August 22, 2011
Last Updated:	June 5, 2013
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Caregivers
Alzheimer Disease
Self-help groups
Psychological stress

Psychological adaptation
Self-efficacy
Internet
Psycho-educational web-based program

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013

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