Clinical trial NCT02092987: Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study
Official title: Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Burden
Keywords: Hispanic
Dementia
Caregivers
Depressive symptoms
Burden
Pragmatic randomized trial
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Hebrew Home at Riverdale
name: NYU Langone Health
name: Burgio Geriatric Consulting
name: Riverstone Senior Life Services
name: Alzheimer's Association
name: Patient-Centered Outcomes Research Institute
First posted: 2014-03-20
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

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

Primary outcomes:
measure: Score on Geriatric Depression Scale
timeFrame: 6 months
measure: Score on Zarit Caregiver Burden Scale
timeFrame: 6 months
Secondary outcomes:
measure: Score on Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale
timeFrame: 6 months
measure: Score on Perceived Stress Scale (PSS)
timeFrame: 6 months
measure: Score on the PROMIS Short Form (SF) Depression Scale
timeFrame: 6 months
measure: Total Score on Patient Health Questionnaire (PHQ-9)
timeFrame: 6 months
Other outcomes:
measure: Score on the Lawton Caregiving Appraisal Scale (CAS) - Burden Subscale
timeFrame: 6 months
measure: Score on Montgomery Objective Burden Scale
timeFrame: 6 months
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jose A Luchsinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.