Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study (NHiCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Columbia University
Sponsor:
Collaborators:
Hebrew Home for the Aged in Riverdale
New York University School of Medicine
Burgio Geriatric Consulting
Riverstone Senior Life Services
Alzheimer's Association, New York City Chapter
Information provided by (Responsible Party):
José A. Luchsinger, Columbia University
ClinicalTrials.gov Identifier:
NCT02092987
First received: March 19, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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 (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.


Condition Intervention
Dementia Caregiver Depressive Symptoms
Dementia Caregiver Burden
Other: Social work support
Other: Educational material

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title: Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Score on Geriatric Depression Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Depressive symptoms measured with the Geriatric depression scale

  • Score on Zarit Caregiver Burden Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Caregiver burden measured with the Zarit Caregiver Burden Scale


Secondary Outcome Measures:
  • Score on Caregiver Physical Health Form [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Caregiver health measured with the Caregiver Physical Health Form.

  • Score on Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Caregiver health measured with the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Health Scale.

  • Score on Perceived Stress Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Caregiver stress measured by the Perceived Stress Scale.

  • Score on the PROMIS Short Form (SF) Depression Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Depressive symptoms measured with thePROMIS SF Depression Scale.

  • Score on Patient Health Questionnaire (PHQ-9) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Depressive symptoms measured with thePatient Health Questionnaire (PHQ-9).


Other Outcome Measures:
  • Score on Caregiving Appraisal Scale - Burden and Satisfaction subscales [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measures caregiver burden.

  • Score on PROMIS SF - Fatigue [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Score on EQ-5D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measures caregiver health related quality of life.

  • Score on EuroQol Visual Analogue Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measures caregiver related quality of life.

  • Score on Objective Burden Subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measures caregiver burden measure.


Estimated Enrollment: 200
Study Start Date: March 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NYU Caregiver Intervention
The first component consists of two individual and 4 family counseling sessions that include relatives suggested by the caregiver. The content of these sessions is determined by the needs of each caregiver and other participating family members These sessions last between one and 1.5 hours. The second component of the intervention is participation in a support group to provide the caregiver with continuous emotional support and education. The third component of the treatment is "ad hoc" counseling—the continuous availability of counselors to caregivers and families to help them deal with crises and with the changing nature and severity of their relatives' symptoms over the course of the disease. The emergence of 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.
Other: Social work support
All study participants will be provided access to social support services at Riverstone Senior Life services
Other: Educational material
All participants receive 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.
Active Comparator: REACH OUT
Problem Solving and Action Plans: 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 In general, problem-solving should be thought of as a "mindset" or guiding strategy to use when working with the caregiver to develop and modify action plans over the intervention period. 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. The first step in REACH OUT is to use a RISK APPRAISAL
Other: Social work support
All study participants will be provided access to social support services at Riverstone Senior Life services
Other: Educational material
All participants receive 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.

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 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092987

Contacts
Contact: Rafi Cabral 646-584-1166 rc2415@cumc.columbia.edu
Contact: Elianny Salcedo 347-4910733 es2749@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Principal Investigator: Jose A Luchsinger, MD         
Sponsors and Collaborators
Columbia University
Hebrew Home for the Aged in Riverdale
New York University School of Medicine
Burgio Geriatric Consulting
Riverstone Senior Life Services
Alzheimer's Association, New York City Chapter
Investigators
Principal Investigator: Jose A Luchsinger, MD Columbia University
  More Information

No publications provided

Responsible Party: José A. Luchsinger, Associate Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT02092987     History of Changes
Other Study ID Numbers: AAAM5150, PCORI_ID_7160
Study First Received: March 19, 2014
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Hispanic
Dementia
Caregivers
Depressive symptoms
Burden
Pragmatic randomized trial

Additional relevant MeSH terms:
Dementia
Depression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 26, 2014