Northern-Manhattan Hispanic Caregiver Intervention Effectiveness Study

NCT ID: NCT02092987

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-10-31

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.

Conditions

Depressive Symptoms; Burden

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

NYU Caregiver Intervention

The New York University (NYU) caregiver intervention arm received the NYU caregiver intervention in addition to social work support and educational materials.

Group Type: EXPERIMENTAL

Social work support

Intervention Type: OTHER

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

Educational material

Intervention Type: OTHER

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 intervention

Intervention Type: BEHAVIORAL

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

The 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.

Group Type: ACTIVE_COMPARATOR

Social work support

Intervention Type: OTHER

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

Educational material

Intervention Type: OTHER

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.

REACH OUT counseling intervention

Intervention Type: BEHAVIORAL

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

Interventions

Social work support

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

Intervention Type: OTHER

Educational material

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.

Intervention Type: OTHER

NYU caregiver counseling intervention

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.

Intervention Type: BEHAVIORAL

REACH OUT counseling intervention

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

Intervention Type: BEHAVIORAL

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).

• 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

Exclusion Criteria

• Not Hispanic

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew Home at Riverdale

OTHER

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: collaborator

Burgio Geriatric Consulting

UNKNOWN

Sponsor Role: collaborator

Riverstone Senior Life Services

UNKNOWN

Sponsor Role: collaborator

Alzheimer's Association

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

José A. Luchsinger

Associate Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose A Luchsinger, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27888180 (View on PubMed)

Other Identifiers

7160

Identifier Type: OTHER

Identifier Source: secondary_id

AAAM5150

Identifier Type: -

Identifier Source: org_study_id