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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
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 d...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5168522/ https://www.ncbi.nlm.nih.gov/pubmed/27888180 http://dx.doi.org/10.1136/bmjopen-2016-014082 |
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author | Luchsinger, José A Burgio, Louis Mittelman, Mary Dunner, Ilana Levine, Jed A Kong, Jian Silver, Stephanie Ramirez, Mildred Teresi, Jeanne A |
author_facet | Luchsinger, José A Burgio, Louis Mittelman, Mary Dunner, Ilana Levine, Jed A Kong, Jian Silver, Stephanie Ramirez, Mildred Teresi, Jeanne A |
author_sort | Luchsinger, José A |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5168522 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-51685222016-12-22 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 Luchsinger, José A Burgio, Louis Mittelman, Mary Dunner, Ilana Levine, Jed A Kong, Jian Silver, Stephanie Ramirez, Mildred Teresi, Jeanne A BMJ Open Mental Health 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. BMJ Publishing Group 2016-11-25 /pmc/articles/PMC5168522/ /pubmed/27888180 http://dx.doi.org/10.1136/bmjopen-2016-014082 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Mental Health Luchsinger, José A Burgio, Louis Mittelman, Mary Dunner, Ilana Levine, Jed A Kong, Jian Silver, Stephanie Ramirez, Mildred Teresi, Jeanne A 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Mental Health |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5168522/ https://www.ncbi.nlm.nih.gov/pubmed/27888180 http://dx.doi.org/10.1136/bmjopen-2016-014082 |
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