N/A
Completed N=221
Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study
Depressive Symptoms · Burden
Source: ClinicalTrials.gov NCT02092987 ↗
Enrolled (actual)
221
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Score on Geriatric Depression Scale — 9.57; 9.80 units on a scale — p=0.70
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Score on Geriatric Depression Scale |
9.57; 9.80 | 0.70 |
| PRIMARY Score on Zarit Caregiver Burden Scale |
36.24; 35.46 | 0.77 |
| SECONDARY Score on Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale |
30.10; 28.68 | 0.51 |
| SECONDARY Score on Perceived Stress Scale (PSS) |
14.98; 14.95 | 0.51 |
| SECONDARY Score on the PROMIS Short Form (SF) Depression Scale |
48.01; 48.51 | 0.76 |
| SECONDARY Total Score on Patient Health Questionnaire (PHQ-9) |
5.40; 4.73 | 0.79 |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- Not Hispanic
- Caregiver is not a relative as defined in the inclusion criteria.
- 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
Data sourced from ClinicalTrials.gov (NCT02092987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.