- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01430286
Web-based Psycho-Educational Program to Support Carers of Alzheimer's Patients (DIAPASON)
Evaluation of a Web-based Psycho-Educational Program for Informal Caregivers of Patients With Alzheimer's Disease (AD).
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Paris, 프랑스, 75013
- Hôpital Broca - la Collégiale, Geriatric Unit, Memory Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Psycho-educational program
This group is trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
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This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
다른 이름들:
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활성 비교기: Standard treatment
This group will receive treatment as usual : consultation in memory clinic every 6 months during the AD patient's consultation.
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This group will receive treatment as usual (consultation in memory clinic every 6 months)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Perceived stress
기간: every 3 months (between 0 and 6 months)
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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).
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every 3 months (between 0 and 6 months)
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2차 결과 측정
결과 측정 |
기간 |
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Nottingham Health Profile (NPH)
기간: every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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ZARIT Burden Interview (BI)
기간: every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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Revised Memory and Behavior Problems Checklist (RMBPC)
기간: every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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Beck Depression Inventory (BDI-2)
기간: every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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Revised Scale for Caregiving Self-Efficacy (RCSE)
기간: every 3 months (between 0 and 6 months)
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every 3 months (between 0 and 6 months)
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Anne-Sophie Rigaud, MD, PhD, Hôpital Broca - la Collégiale, Memory Clinic
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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, 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.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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