Northern Manhattan Caregiver Intervention Project - Full Text View

Purpose

Elderly Hispanics have a higher burden of dementia compared to Non-Hispanic Whites. Furthermore, Hispanic caregivers tend to have a higher burden of care for their relatives with dementia. The objective of this application is to conduct a randomized trial in 160 Hispanic relative caregivers of persons with dementia comparing the effectiveness of New York University Caregiver Intervention to a case management intervention lead by community health workers(CHW). This trial will last 6 months. The main outcomes in the trial will be changes in depressive symptoms measured with the Geriatric Depression Scale and caregiver burden measured with the Zarit Caregiver Burden Scale. This research project will be conducted by the Northern Manhattan Center of Excellence in Comparative Effectiveness Research for Eliminating Disparities (NOCERED) funded by the National Institute on Minority Health and Health Disparities.

Condition	Intervention
Dementia	Behavioral: New York University Caregiver Intervention (NYUCI) Other: Community Health Worker Case Management

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Comparative Effectiveness of the NYU Caregiver Intervention in Latinos in Northern Manhattan

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Dementia Depression

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Changes in Caregiver Depressive Symptoms [ Time Frame: Up to 6 months from study completion ] [ Designated as safety issue: No ]
Measured with the geriatric depression scale (GDS)

Secondary Outcome Measures:

Changes in Caregiver Burden [ Time Frame: Up to 6 months from study completion ] [ Designated as safety issue: No ]
Measured with the Zarit Caregiver Burden Interview.

Enrollment:	139
Study Start Date:	March 2011
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NYUCI New York University Caregiver Intervention (NYUCI) in addition to community-based case management using community health workers.	Behavioral: New York University Caregiver Intervention (NYUCI) The NYU Caregiver Intervention (NYUCI) has substantial evidence of efficacy. This intervention is unique in its emphasis on family support and in providing ongoing availability of the counselor. While the NYUCI is being implemented in several communities, its effectiveness in the Hispanic community of Northern Manhattan has not been tested. The first component of the intervention consists of two individual and four family counseling sessions that include relatives suggested by the caregiver. The second component of the intervention is participation in a support group to provide the caregiver with continuous emotional support and education. The third component of the treatment is "ad hoc" counseling the continuous availability of counselors to caregivers and families to help them deal with crises and with the changing nature and severity of their relatives' symptoms over the course of the disease. Other Name: NYU Caregiver Intervention
CHW Community-based case management using community health workers (CHWs).	Other: Community Health Worker Case Management The CHW intervention will consist of 2 visits in month 1, followed by monthly visits until month 6. The main role of the CHW will be to provide access to existing education and referral resources about dementia and caregiving. In addition, CHW will assess other health and social issues and provide information on existing resources on Northern Manhattan. The CHW will carry a blackberry or iPhone type device with real time access to email, text, the internet, and telephone. Thus, the CHW will be able to provide participants with real time information from pertinent websites such as CUMC, Alianza, and the NY chapter of the Alzheimer's Association. CHW will also provide participants with their phone number and email address for ad-hoc contacts. Other Name: CHW

Arms

Assigned Interventions

Experimental: NYUCI

New York University Caregiver Intervention (NYUCI) in addition to community-based case management using community health workers.

Behavioral: New York University Caregiver Intervention (NYUCI)

The NYU Caregiver Intervention (NYUCI) has substantial evidence of efficacy. This intervention is unique in its emphasis on family support and in providing ongoing availability of the counselor. While the NYUCI is being implemented in several communities, its effectiveness in the Hispanic community of Northern Manhattan has not been tested. The first component of the intervention consists of two individual and four family counseling sessions that include relatives suggested by the caregiver. The second component of the intervention is participation in a support group to provide the caregiver with continuous emotional support and education. The third component of the treatment is "ad hoc" counseling the continuous availability of counselors to caregivers and families to help them deal with crises and with the changing nature and severity of their relatives' symptoms over the course of the disease.

Other Name: NYU Caregiver Intervention

CHW

Community-based case management using community health workers (CHWs).

Other: Community Health Worker Case Management

The CHW intervention will consist of 2 visits in month 1, followed by monthly visits until month 6. The main role of the CHW will be to provide access to existing education and referral resources about dementia and caregiving. In addition, CHW will assess other health and social issues and provide information on existing resources on Northern Manhattan. The CHW will carry a blackberry or iPhone type device with real time access to email, text, the internet, and telephone. Thus, the CHW will be able to provide participants with real time information from pertinent websites such as CUMC, Alianza, and the NY chapter of the Alzheimer's Association. CHW will also provide participants with their phone number and email address for ad-hoc contacts.

Other Name: CHW

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Must be caring for a relative with a clinical diagnosis of dementia and have the primary responsibility for their care. All people with dementia must be living at home with their caregiver when they enroll in the study.
In each family, the person with dementia or the caregiver has to have at least one relative living in the New York City metropolitan area.
The caregiver must be emotionally and physically capable of participating. Caregivers with clinical depression or other serious mental illness will be referred.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306695

Locations

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Jose Luchsinger, MD, MPH

Columbia University

More Information

Publications:

Luchsinger J, Mittelman M, Mejia M, Silver S, Lucero RJ, Ramirez M, Kong J, Teresi JA. The Northern Manhattan Caregiver Intervention Project: a randomised trial testing the effectiveness of a dementia caregiver intervention in Hispanics in New York City. BMJ Open. 2012 Sep 14;2(5). doi:pii: e001941. 10.1136/bmjopen-2012-001941. Print 2012.

Andrieu S, Aboderin I, Baeyens JP, Beard J, Benetos A, Berrut G, Brainin M, Cha HB, Chen LK, Du P, Forette B, Forette F, Franco A, Fratiglioni L, Gillette-Guyonnet S, Gold G, Gomez F, Guimaraes R, Gustafson D, Khachaturian A, Luchsinger J, Mangialasche F, Mathiex-Fortunet H, Michel JP, Richard E, Schneider LS, Solomon A, Vellas B. IAGG workshop: health promotion program on prevention of late onset dementia. J Nutr Health Aging. 2011 Aug;15(7):562-75.

Responsible Party:	José A. Luchsinger, Associate Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier:	NCT01306695 History of Changes
Other Study ID Numbers:	AAAI0022, 3P60MD000206-08S1
Study First Received:	February 28, 2011
Last Updated:	March 13, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

Dementia
Depressive symptoms
Caregiver Burden
Hispanic

Latino
Intervention
Geriatric Depression Scale
Zarit Caregiver Burden Scale

Additional relevant MeSH terms:

Dementia
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013

Northern Manhattan Caregiver Intervention Project (NOCIP)