Coordinating Center for Caregiver Intervention Trial (REACH)
Coordinating Center for Multisite Intervention Trial for Diverse Caregivers
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
The proposed Coordinating Center (CC) will work with five sites and staff from the National Institute on Aging (NIA) and the National Institute of Nursing Research (NINR) to implement a multi-site caregiver intervention trial. The overall objective of this research program is to refine and test a multicomponent psychosocial intervention to reduce burden and depression among family caregivers of persons with Alzheimer's Disease or a related disorder. This competing renewal will build upon results obtained from its parent multi-site feasibility study, Resources for Enhancing Alzheimer's Caregiver Health (REACH) funded by the NIA/NINR as a cooperative agreement (UO1-AG13305). In the study proposed here, five intervention sites (Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) will recruit 600 (120 per site) caregiver-care recipient dyads consisting of equal numbers of African Americans/Blacks, Hispanics/Latinos, and Caucasians/Whites. Caregivers will be randomized to either an in-home multicomponent intervention condition or a standardized information-only control condition.
The Coordinating Center at the University of Pittsburgh will work with the intervention site investigators and the NIA/NINR to support the implementation of the intervention study at each site and to collect and analyze a common database across sites.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35294-2041
- University of Alabama at Birmingham
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California
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Menlo Park, California, Spojené státy, 94025
- Stanford University and Veterans Affairs
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Florida
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Miami, Florida, Spojené státy, 33136
- University of Miami at Miami, Center on Adult Development and Aging
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Thomas Jefferson University at Philadelphia, Center for Applied Research on Aging and Health
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Tennessee
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Memphis, Tennessee, Spojené státy, 38163
- University of Tennessee Health Science Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Caregiver Inclusion/Exclusion Criteria:
Inclusion Criteria:
- Age: 21 years or older
- Family member of the care recipient
- Must live with care recipient or share cooking facilities
- Must have a telephone that will enable use of CTIS (Computer Telephone Integration System) system
- Must plan to remain in the recruitment area for the duration of the intervention and follow-up
- Caregiver role for more than 6 months
- Must provide on average 4 hours of supervision or direct assistance per day for the care recipient
- Risk Screening Tool: must have a total score of at least 1 for questions 1-3, and a total of at least 2 for questions 4-9
Exclusion Criteria:
- Non-English, non-Spanish speaking
- Active treatment (chemotherapy, radiation therapy) for cancer
- Imminent placement of care recipient into a nursing home or with another caregiver (within 6 months)
- Involvement in another clinical trial for caregivers
- Participant in REACH I study
SPMSQ:> or = 4 errors*
- If the caregiver has been inconsistent with answers or repeated answers during the screening process, then the interviewer administers the Short Portable Mental Status Questionnaire (SPMSQ). If the caregiver missed 4 or more questions, he/she was excluded from the study.
Care Recipient Inclusion/Exclusion Criteria
Inclusion Criteria:
a. NINCDS (MD diagnosis) of dementia or cognitive impairment (raw score on MMSE of 23 or less)
Exclusion Criteria:
- Non-English, non-Spanish speaking
- History of Parkinson's Disease or a stroke with no reported decline in memory over the past year
- Active treatment (chemotherapy, radiation therapy) for cancer
- More than three acute medical hospitalizations in past year (other than psychiatric or Alzheimer's Disease related admission)
- Schizophrenia (onset of delusions before age 45) or other severe mental illness
- Dementia secondary to head trauma (probable)
- Blindness or deafness if either disability prohibits them from completion of data collection or participation in the interventions
- MMSE = 0 and Bedbound (confined to a bed or chair for >22 hours per day, for at least 4 of the past 7 days)
- Planned nursing home admission in 6 months
- Participant in REACH I study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Treatment
The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
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The intervention addressed caregiver depression, burden, self-care, and social support and care recipient problem behaviors through 12 in-home and telephone sessions over 6 months.
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Jiný: Control
Caregivers in the control group received 2 brief "check-in" telphone calls during the 6 month intervention.
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Caregivers in the control group received 2 brief "check-in" telephone calls during the 6-month intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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multivariate quality of life indicator- assessed caregiver burden, depressive symptoms, self-care, social support and patient problem behaviors. Assessed at six months post-randomization.
Časové okno: six months
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six months
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Caregiver clinical depression and patient institutional placement-six months post-randomization.
Časové okno: six months
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six months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Richard Schulz, Ph.D., Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh
Publikace a užitečné odkazy
Obecné publikace
- Belle SH, Burgio L, Burns R, Coon D, Czaja SJ, Gallagher-Thompson D, Gitlin LN, Klinger J, Koepke KM, Lee CC, Martindale-Adams J, Nichols L, Schulz R, Stahl S, Stevens A, Winter L, Zhang S; Resources for Enhancing Alzheimer's Caregiver Health (REACH) II Investigators. Enhancing the quality of life of dementia caregivers from different ethnic or racial groups: a randomized, controlled trial. Ann Intern Med. 2006 Nov 21;145(10):727-38. doi: 10.7326/0003-4819-145-10-200611210-00005.
- Nichols LO, Martindale-Adams J, Burns R, Graney MJ, Zuber J. Typical and atypical dementia family caregivers: systematic and objective comparisons. Int J Aging Hum Dev. 2011;72(1):27-43. doi: 10.2190/AG.72.1.b.
- Elliott AF, Burgio LD, Decoster J. Enhancing caregiver health: findings from the resources for enhancing Alzheimer's caregiver health II intervention. J Am Geriatr Soc. 2010 Jan;58(1):30-7. doi: 10.1111/j.1532-5415.2009.02631.x.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AG13305
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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