Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study
NHiCE
2 other identifiers
interventional
221
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
July 9, 2021
CompletedJuly 9, 2021
September 1, 2020
2.5 years
March 19, 2014
November 30, 2016
July 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Score on Geriatric Depression Scale
The Geriatric Depression Scale (GDS) is a 30-item self-report assessment used to identify depression in the elderly. The GDS questions are answered "yes" or "no", instead of a five-category response set. One point is assigned to each answer and the cumulative score is rated on a scoring grid. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".Higher scores indicate more depressive symptoms.
6 months
Score on Zarit Caregiver Burden Scale
Zarit Caregiver Burden Scale measures caregiver burden by asking caregivers to respond to a series of 22 questions about the impact of the patient's disabilities on their life. For each item, caregivers are to indicate how often they felt that way (never, rarely, sometimes, quite frequently, or nearly always). The Burden Interview is scored by adding the numbered responses of the individual items. Higher scores indicate greater caregiver distress. Estimates of the degree of burden can be made from preliminary findings: 0 - 20 (little or no burden), 21 - 40 (mild to moderate burden), 41 - 60 (moderate to severe burden), and 61 - 88 (severe burden).
6 months
Secondary Outcomes (4)
Score on Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale
6 months
Score on Perceived Stress Scale (PSS)
6 months
Score on the PROMIS Short Form (SF) Depression Scale
6 months
Total Score on Patient Health Questionnaire (PHQ-9)
6 months
Other Outcomes (2)
Score on the Lawton Caregiving Appraisal Scale (CAS) - Burden Subscale
6 months
Score on Montgomery Objective Burden Scale
6 months
Study Arms (2)
NYU Caregiver Intervention
EXPERIMENTALThe New York University (NYU) caregiver intervention arm received the NYU caregiver intervention in addition to social work support and educational materials.
REACH OUT
ACTIVE COMPARATORThe Resources for Enhancing Caregiver Health Offering Useful Treatments (REACH OUT) intervention arm received the REACH OUT caregiver intervention in addition to social work support and educational materials.
Interventions
All study participants were provided access to social support services at Riverstone Senior Life services
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.
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.
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
Eligibility Criteria
You may qualify if:
- Self identified Hispanic
- Between the ages of 18 and 90.
- Caregiver is related to persons receiving care either as a spouse (including common law partners) or a blood or in-law relative.
- Person receiving care has been diagnosed with dementia and reports at least 1 memory/cognition and 1 daily functioning symptom in our screening questionnaire (see appendix).
- Caregiver is physically able to provide care
- Caregiver does not have a diagnosis of major psychiatric disorder other than depression.
- Caregiver does not have depression with psychotic features or suicidal ideation or attempts in the last 5 years.
- Caregiver is expected to live in New York City in the next 6 months or is available for study procedures in the New York City area.
- There is at least one relative or close friend living in the New York City Metropolitan Area (New York, New Jersey, Connecticut).
You may not qualify if:
- Not Hispanic
- Person receiving care does not have dementia
- Other than depression, caregiver has a major psychiatric disorder such as schizophrenia
- Caregiver has depression with psychotic features or suicidal ideation in the last 5 years.
- Severe depression defined by a Patient Health Questionnaire (PHQ)-9 \> 20.
- Previous or current participation in caregiver support programs with the NYUCI or the REACH OUT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Hebrew Home at Riverdalecollaborator
- NYU Langone Healthcollaborator
- Burgio Geriatric Consultingcollaborator
- Riverstone Senior Life Servicescollaborator
- Alzheimer's Associationcollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (1)
Luchsinger JA, Burgio L, Mittelman M, Dunner I, Levine JA, Kong J, Silver S, Ramirez M, Teresi JA. Northern Manhattan Hispanic Caregiver Intervention Effectiveness Study: protocol of a pragmatic randomised trial comparing the effectiveness of two established interventions for informal caregivers of persons with dementia. BMJ Open. 2016 Nov 25;6(11):e014082. doi: 10.1136/bmjopen-2016-014082.
PMID: 27888180DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was designed with a relatively short follow-up of 6 months which may have been too short to observe any significant chance in depressive symptoms. In addition, anxiety was not measured.
Results Point of Contact
- Title
- Jose Luchsinger
- Organization
- Columbia University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jose A Luchsinger, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine and Epidemiology
Study Record Dates
First Submitted
March 19, 2014
First Posted
March 20, 2014
Study Start
March 1, 2014
Primary Completion
September 1, 2016
Study Completion
October 1, 2016
Last Updated
July 9, 2021
Results First Posted
July 9, 2021
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share