CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 221 enrolled
Drug / intervention
Social work support +3 moreother
Likely dose
Not stated in record
Key inclusion· 7
  • Self-identified Hispanic ethnicity
  • Age 18-90 years
  • Related to care recipient as spouse (including common law) or blood/in-law relative
  • Care recipient has dementia with documented memory/cognition and daily functioning impairment
Key exclusion· 7
  • Not Hispanic
  • Not a relative as defined (non-spouse, non-blood, non-in-law relationship to care recipient)
  • Care recipient does not have dementia
  • Major psychiatric disorder other than depression (e.g., schizophrenia)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02092987
NCT02092987N/ACompleted

Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study

Columbia University·interventional·Posted Mar 20, 2014·Updated Jul 9, 2021

In Brief

A clinical study evaluating Social work support, Educational material, and 2 other interventions for Depressive Symptoms and Burden. Completed, enrolled 221 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 20, 2014
Enrollment StartMar 1, 2014
Primary CompletionSep 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 12.3 years ago

Interventions

Social work supportother

All study participants were provided access to social support services at Riverstone Senior Life services

Educational materialother

All participants received educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.

NYU caregiver counseling interventionbehavioral

The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is "ad hoc" counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers.

REACH OUT counseling interventionbehavioral

All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed