- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01306695
Northern Manhattan Caregiver Intervention Project (NOCIP)
Comparative Effectiveness of the NYU Caregiver Intervention in Latinos in Northern Manhattan
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: NYUCI
New York University Caregiver Intervention (NYUCI) in addition to community-based case management using community health workers: The first component consists of two individual and four family counseling sessions that include relatives suggested by the caregiver.
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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 Names:
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Other: CHW Intervention
Community-based case management using community health workers (CHWs): The CHW intervention will consist of 2 visits in month 1, followed by monthly visits until month 6.
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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.
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver Depressive Symptoms
Time Frame: Up to 6 months from study completion
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Measured with the geriatric depression scale (GDS)
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Up to 6 months from study completion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Caregiver Burden
Time Frame: Up to 6 months from study completion
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Measured with the Zarit Caregiver Burden Interview.
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Up to 6 months from study completion
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jose Luchsinger, MD, MPH, Columbia University
Publications and helpful links
General 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):e001941. doi: 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. doi: 10.1007/s12603-011-0142-1.
- Luchsinger JA, Tipiani D, Torres-Patino G, Silver S, Eimicke JP, Ramirez M, Teresi J, Mittelman M. Characteristics and mental health of Hispanic dementia caregivers in New York City. Am J Alzheimers Dis Other Demen. 2015 Sep;30(6):584-90. doi: 10.1177/1533317514568340. Epub 2015 Jan 29.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAI0022
- P60MD000206 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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