Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study — NHiCE  

Depressive Symptoms Clinical Trial

Official title: Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study

Status Completed

Clinical Trial Summary

The primary research question is which of the 2 best known dementia caregiver interventions, the New York University Caregiver intervention (NYUCI) and Resources for Enhancing Caregivers Health Offering Useful Treatments (REACH OUT), is more effective in alleviating depressive symptoms and caregiver burden among Hispanic caregivers in New York City. The investigators hypothesize that the NYUCI will be more effective than REACH OUT in reducing caregiver depressive symptoms and burden among Hispanics because of its focus on family-centered counseling, which is posited to be more important among Hispanic caregivers because of a cultural emphasis among Hispanics on family interactions in interventions. In order to answer the primary question, the investigators will conduct a pragmatic randomized trial comparing the NYUCI vs. REACH OUT in 200 Hispanic caregivers of persons with dementia in the community of Northern Manhattan. The total time of the intervention will be 6 months. Our research question is which intervention, NYUCI or REACH OUT, is better in Hispanic relative (any relative) caregivers of persons with dementia. Our objective is to obtain effectiveness information that will help caregivers and health providers to make decisions about which intervention to choose. Our primary aim is to compare the effectiveness of the implementation of the NYUCI and REACH OUT in reducing depressive symptoms and burden. Our exploratory aims are to examine and compare the predictors of effectiveness of the NYUCI and REACH OUT and to examine additional outcomes such as caregiver stress and physical health, and outcomes related to the person with dementia. METHODS. We will conduct a pragmatic randomized trial of 200 relative caregivers of persons with dementia. Participants will be randomized to the NYUCI or REACH OUT. The total duration of the intervention will be 6 months, with assessments at baseline and follow-up. All interventions and questionnaires will be conducted in both English and Spanish. The study duration will be 3 years. The primary outcomes will be changes in caregiver depressive symptoms, measured with the Geriatric Depression Scale, and in caregiver burden using the Zarit caregiver burden interview.

Clinical Trial Description

The prevalence of dementia is increasing with the aging of the population and the absence of prevention or cure. Thus, the burden of dementia on caregivers is also increasing. Hispanics have a higher prevalence of dementia than non-Hispanic Whites (NHW), have higher caregiving burden, and may have less economic resources to cope with the caregiving burden. However, there is a paucity of evidence on the effectiveness of caregiver interventions in Hispanics. We propose to compare 2 interventions with evidence of efficacy, the New York University Caregiver intervention (NYUCI) and the translated Resources for Enhancing Caregivers Health Offering Useful Treatments (REACH OUT). The NYUCI is a family centered counseling intervention that focuses on reducing negative family interactions and improving family support of the primary caregiver. REACH OUT focuses on caregiver skills training through action-oriented formal problem solving, goal setting, and written action plans. The effectiveness of the NYUCI and the REACH OUT has never been compared. Thus, there is no way for caregivers to decide which intervention to choose. In addition, there is a paucity of data on the effectiveness of both interventions in Hispanics. ;

Related Conditions & MeSH terms

• Burden
• Depression
• Depressive Symptoms

• NCT number: NCT02092987
• Study type: Interventional
• Source: Columbia University
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: October 2016