Northern Manhattan Caregiver Intervention Project

NCT01306695 | Completed DMC

• 2 other identifiers: AAAI0022P60MD000206
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia

Keywords

Dementia; Depressive symptoms; Caregiver Burden; Hispanic; Latino; Intervention; Geriatric Depression Scale; Zarit Caregiver Burden Scale

Outcome Measures

Primary Outcomes (1)

• Change in Caregiver Depressive Symptoms

  Measured with the geriatric depression scale (GDS)

  Up to 6 months from study completion

Secondary Outcomes (1)

• Change in Caregiver Burden

  Up to 6 months from study completion

Study Arms (2)

NYUCI

EXPERIMENTAL

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.

Behavioral: New York University Caregiver Intervention (NYUCI)

CHW Intervention

OTHER

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.

Other: Community Health Worker (CHW) Case Management

Interventions

New York University Caregiver Intervention (NYUCI) BEHAVIORAL

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.

Also known as: NYU Caregiver Intervention

NYUCI

Community Health Worker (CHW) Case Management OTHER

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.

Also known as: CHW

CHW Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

• 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.

  PMID: 22983877 BACKGROUND

• 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.

  PMID: 21808935 BACKGROUND

• 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.

  PMID: 25635108 BACKGROUND

MeSH Terms

Conditions

Dementia; Depression; Caregiver Burden

Interventions

Community Health Workers; Case Management

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Stress, Psychological

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jose Luchsinger, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: February 28, 2011
• First Posted: March 2, 2011
• Study Start: March 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

US (1)