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

NCT01430286 | Completed

• 1 other identifier: P081002
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Caregivers; Alzheimer Disease; Psychological stress; Psychological adaptation; Self-efficacy; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Nottingham Health Profile (NPH)

  every 3 months (between 0 and 6 months)

• ZARIT Burden Interview (BI)

  every 3 months (between 0 and 6 months)

• Revised Memory and Behavior Problems Checklist (RMBPC)

  every 3 months (between 0 and 6 months)

• Beck Depression Inventory (BDI-2)

  every 3 months (between 0 and 6 months)

• Revised Scale for Caregiving Self-Efficacy (RCSE)

  every 3 months (between 0 and 6 months)

Study Arms (2)

Psycho-educational program

EXPERIMENTAL

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.

Standard treatment

ACTIVE COMPARATOR

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

Interventions

Consultation in memory clinic BEHAVIORAL

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

Standard treatment

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

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

Also known as: Web-based psycho-educational program

Psycho-educational program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Direction de l'Hospitalisation et de l'Organisation des Soins (PREQHOS): collaborator
• Fondation Mederic Alzheimer: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic

Paris, 75013, France

Location

Related Publications (29)

• Ankri J, Andrieu S, Beaufils B, Grand A, Henrard JC. Beyond the global score of the Zarit Burden Interview: useful dimensions for clinicians. Int J Geriatr Psychiatry. 2005 Mar;20(3):254-60. doi: 10.1002/gps.1275.

  PMID: 15717336 BACKGROUND

• Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.

  PMID: 11832252 BACKGROUND

• 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. doi: 10.2190/AN6L-6QBQ-76G0-0N9A.

  PMID: 8886875 BACKGROUND

• 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. doi: 10.1034/j.1600-0579.2003.00210.x.

  PMID: 12752841 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

  PMID: 7991117 BACKGROUND

• Eisdorfer C, Czaja SJ, Loewenstein DA, Rubert MP, Arguelles S, Mitrani VB, Szapocznik J. The effect of a family therapy and technology-based intervention on caregiver depression. Gerontologist. 2003 Aug;43(4):521-31. doi: 10.1093/geront/43.4.521.

  PMID: 12937331 BACKGROUND

• 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. doi: 10.1037/0882-7974.22.1.37.

  PMID: 17385981 BACKGROUND

• Gottlieb BH, Wolfe J. Coping with family caregiving to persons with dementia: a critical review. Aging Ment Health. 2002 Nov;6(4):325-42. doi: 10.1080/1360786021000006947.

  PMID: 12425767 BACKGROUND

• 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. doi: 10.1136/bmj.312.7024.153.

  PMID: 8563534 BACKGROUND

• 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. doi: 10.1176/appi.ajp.157.5.708.

  PMID: 10784462 BACKGROUND

• 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. doi: 10.1212/wnl.34.7.939.

  PMID: 6610841 BACKGROUND

• Mahoney DF, Tarlow BJ, Jones RN. Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. Gerontologist. 2003 Aug;43(4):556-67. doi: 10.1093/geront/43.4.556.

  PMID: 12937334 BACKGROUND

• 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. doi: 10.1016/s0020-7489(01)00034-7.

  PMID: 11909614 BACKGROUND

• 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. doi: 10.1093/geronb/59.1.p27.

  PMID: 14722336 BACKGROUND

• Moniz-Cook E, Vernooij-Dassen M, Woods R, Verhey F, Chattat R, De Vugt M, Mountain G, O'Connell M, Harrison J, Vasse E, Droes 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.

  PMID: 18297476 BACKGROUND

• 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.

  PMID: 12773869 BACKGROUND

• 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. doi: 10.1093/geront/35.6.771.

  PMID: 8557205 BACKGROUND

• Schulz R, Beach SR. Caregiving as a risk factor for mortality: the Caregiver Health Effects Study. JAMA. 1999 Dec 15;282(23):2215-9. doi: 10.1001/jama.282.23.2215.

  PMID: 10605972 BACKGROUND

• Schulz R, Martire LM, Klinger JN. Evidence-based caregiver interventions in geriatric psychiatry. Psychiatr Clin North Am. 2005 Dec;28(4):1007-38, x. doi: 10.1016/j.psc.2005.09.003. No abstract available.

  PMID: 16325738 BACKGROUND

• Sorensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002 Jun;42(3):356-72. doi: 10.1093/geront/42.3.356.

  PMID: 12040138 BACKGROUND

• 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.

  PMID: 9339271 BACKGROUND

• Teri L, Logsdon RG, McCurry SM. Nonpharmacologic treatment of behavioral disturbance in dementia. Med Clin North Am. 2002 May;86(3):641-56, viii. doi: 10.1016/s0025-7125(02)00006-8.

  PMID: 12168563 BACKGROUND

• Yesavage JA. Geriatric depression scale: consistency of depressive symptoms over time. Percept Mot Skills. 1991 Dec;73(3 Pt 1):1032. doi: 10.2466/pms.1991.73.3.1032. No abstract available.

  PMID: 1792116 BACKGROUND

• Zarit SH, Todd PA, Zarit JM. Subjective burden of husbands and wives as caregivers: a longitudinal study. Gerontologist. 1986 Jun;26(3):260-6. doi: 10.1093/geront/26.3.260. No abstract available.

  PMID: 3721233 BACKGROUND

• Cristancho-Lacroix V, Kerherve H, de Rotrou J, Rouquette A, Legouverneur G, Rigaud AS. Evaluating the efficacy of a web-based program (diapason) for informal caregivers of patients with Alzheimer's disease: protocol for a randomized clinical trial. JMIR Res Protoc. 2013 Dec 6;2(2):e55. doi: 10.2196/resprot.2978.

  PMID: 24317497 RESULT

• Cristancho-Lacroix V, Moulin F, Wrobel J, Batrancourt B, Plichart M, De Rotrou J, Cantegreil-Kallen I, Rigaud AS. A web-based program for informal caregivers of persons with Alzheimer's disease: an iterative user-centered design. JMIR Res Protoc. 2014 Sep 15;3(3):e46. doi: 10.2196/resprot.3607.

  PMID: 25263541 RESULT

• Cristancho-Lacroix V, Wrobel J, Cantegreil-Kallen I, Dub T, Rouquette A, Rigaud AS. A web-based psychoeducational program for informal caregivers of patients with Alzheimer's disease: a pilot randomized controlled trial. J Med Internet Res. 2015 May 12;17(5):e117. doi: 10.2196/jmir.3717.

  PMID: 25967983 RESULT

• Gonzalez-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozua B, Sola I, McCleery J. Remotely delivered information, training and support for informal caregivers of people with dementia. Cochrane Database Syst Rev. 2021 Jan 4;1(1):CD006440. doi: 10.1002/14651858.CD006440.pub3.

  PMID: 33417236 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Stress, Psychological

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Anne-Sophie Rigaud, MD, PhD

  Hôpital Broca - la Collégiale, Memory Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: September 8, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

FR (1)