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Northern Manhattan Caregiver Intervention Project (NOCIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
José A. Luchsinger, Columbia University
ClinicalTrials.gov Identifier:
NCT01306695
First received: February 28, 2011
Last updated: March 19, 2014
Last verified: March 2014
  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 project 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 (CHW) 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:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change 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:
  • Change 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: May 2014
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 (CHW) 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

Detailed Description:

The goal of this study is to compare the effectiveness of an existing evidence-based dementia family caregiver intervention, the New York University Caregiver Intervention (NYUCI), to community-based case management using community health workers (CHWs) in Hispanic caregivers in Northern Manhattan. The investigators will randomize 160 relative caregivers of persons with dementia to case management alone or NYUCI in addition to case management. The total duration of followup will be 6 months. We will call this project the Northern Manhattan Caregiver Intervention Project (NOCIP).

The primary aim is to compare changes from baseline to 6 months in caregiver depressive symptoms, measured with the geriatric depression scale (GDS), and in caregiver burden using the Zarit caregiver burden interview (ZBI), between the randomization arms using an Intent to treat approach. The investigators hypothesize that depressive symptoms and caregiver burden will improve or deteriorate less in the NYUCI arm compared to the case management arm at 6 months.

This project addresses one of the priority areas for comparative effectiveness research (CER) from the Institute of Medicine, "interventions for caregivers of persons with dementia". It also addresses 2 priority conditions from the Agency for Health Care Research and Quality (AHRQ): Dementia and Depression. Dementia caregiver burden is a major source of disparities in Northern Manhattan. The prevalence of dementia in Hispanics is twice that of Non-Hispanic Whites. In addition, Hispanic families tend to be reluctant to delegate the care of their relatives with dementia and consider it a family affair. Thus, the burden of care-giving for persons with dementia is much higher in Hispanic families. NOCIP will be the first study to test the effectiveness of an existing caregiver intervention, the New York University Caregiver Intervention, in the Hispanic community of Northern Manhattan. In addition, the NYUCI has been tested in spouse caregivers, and NOCIP will be the first randomized clinical trial to include non-spouse caregivers.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Jose Luchsinger, MD, MPH Columbia University
  More Information

Publications:
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 19, 2014
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014