- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00177489
Coordinating Center for Caregiver Intervention Trial (REACH)
Coordinating Center for Multisite Intervention Trial for Diverse Caregivers
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294-2041
- University of Alabama at Birmingham
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California
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Menlo Park, California, États-Unis, 94025
- Stanford University and Veterans Affairs
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Florida
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Miami, Florida, États-Unis, 33136
- University of Miami at Miami, Center on Adult Development and Aging
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 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, États-Unis, 38163
- University of Tennessee Health Science Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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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.
Délai: six months
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six months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Caregiver clinical depression and patient institutional placement-six months post-randomization.
Délai: six months
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six months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Richard Schulz, Ph.D., Professor of Psychiatry and Director, University Center for Social and Urban Research, University of Pittsburgh
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AG13305
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur multicomponent psychosocial intervention
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Duke UniversityGlioblastoma FoundationActif, ne recrute pas
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University of California, DavisUniversity of South CarolinaComplété
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Hospices Civils de LyonInconnueMaladie d'AlzheimerFrance
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University of WashingtonNational Cancer Institute (NCI)Complété
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City of Hope Medical CenterNational Cancer Institute (NCI)Complété
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University of ManchesterInconnueLa dépression | Fatigue | Cancer du poumon | Dyspnée | Trouble anxieuxRoyaume-Uni
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U.S. Army Medical Research and Development CommandWalter Reed Army Medical Center; Ohio State UniversityInconnueTumeurs du col de l'utérus | Tumeurs génitales, femme | Tumeurs ovariennes | Tumeurs de l'endomètre | Tumeurs vulvaires | Tumeurs vaginalesÉtats-Unis
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Gazi UniversityPas encore de recrutementCancer | Enfant, seul | Autonomisation