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Abstract
Introduction The prevalence of dementia is increasing without a known cure, resulting in an increasing number of informal caregivers. Caring for a person with dementia results in increased stress and depressive symptoms. There are several behavioural interventions designed to alleviate stress and depressive symptoms in caregivers of persons with dementia with evidence of efficacy. Two of the best-known interventions are the New York University Caregiver Intervention (NYUCI) and the Resources for Enhancing Alzheimer's Caregivers Health (REACH). The effectiveness of the NYUCI and REACH has never been compared. There is also a paucity of data on which interventions are more effective in Hispanics in New York City. Thus, we proposed the Northern Manhattan Hispanic Caregiver intervention Effectiveness Study (NHiCE), a pragmatic clinical trial designed to compare the effectiveness of adaptations of the NYUCI and the REACH in informal Hispanic caregivers of persons with dementia in New York City.
Methods and analysis NHiCE is a 6-month randomised controlled trial comparing the effectiveness of adaptations of the NYUCI and REACH among 200 Hispanic informal adult caregivers of persons with dementia. The planned number of sessions of the NYUCI and REACH are similar. The primary outcome measures are changes from baseline to 6 months in the Zarit Caregiver Burden Scale and Geriatric Depression Scale. Our primary approach to analyses will be intent-to-treat. The primary analyses will use mixed random effects models, and a full information maximum likelihood approach, with sensitivity analyses using generalised estimating equation.
Ethics and dissemination NHiCE is approved by the Institutional Review Board of Columbia University Medical Center (protocol AAAM5150). A Data Safety Monitoring Board monitors the progress of the study. Dissemination will include reports of the characteristics of the study participants, as well as a report of the results of the clinical trial.
Trial registration number NCT02092987, Pre-results.
- caregiving
- Alzheimer
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Footnotes
Contributors JAL is the study principal investigator and was responsible for obtaining funding, designing the study and drafting this manuscript; LB is a study co-principal investigator and was responsible for co-designing the study, designing the REACH implementation and drafting this manuscript. MM is a study co-principal investigator and was responsible for co-designing the study, designing the NYUCI implementation and drafting this manuscript; ID is the executive director of our community-based research partner Riverstone Senior Life Services and reviewed and approved the manuscript for content. JAL is the Executive Vice President and Director of programmes and services at our community research partner, Caringkind, formerly the Alzheimer's Association, New York City Chapter. MR and SS were responsible for the design of study logistics and questionnaires; JAT is the leader of the data-coordinating centre and was responsible for the overall study design, the statistical plan and drafting of this manuscript. JK assisted JAT with the development of the statistical plan. All authors read and approved the final manuscript.
Funding The primary source for the funding of this project is PCORI contract CE-1304-7160. Partial support for participant assessments is provided by the Irving Institute of Clinical Translational Research at Columbia University Medical Center, funded by a Clinical Translational Science Award (UL1 RR024156).
Disclaimer The content is solely the responsibility of the authors and does necessarily represent the official views of funding agency.
Competing interests MM is the developer of the NYUCI and has received consulting fees for training providers. She is currently working on a Small Business Innovation Research grant to develop online training for the NYUCI. It is possible that MM will benefit in the future from the distribution of NYUCI training materials. LB is the developer of the REACH OUT caregiver support program and has received consulting fees for training providers. He is currently working with Oxford University Press to publish a version of the REACH OUT training manual. It is possible that LB will benefit in the future from the distribution of REACH OUT training materials. The other author(s) declare that they have no competing interests.
Ethics approval Institutional Review Board of Columbia University Medical Center.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
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