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Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial
INTRODUCTION: Heart failure (HF) as a long-term clinical syndrome is associated with inadequate self-care behaviours, a feeling of uncertainty and frequent hospitalisation. In recent years, empowerment has evolved for improving chronic disease management. Nevertheless, there is a lack of studies inv...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10414091/ https://www.ncbi.nlm.nih.gov/pubmed/37558436 http://dx.doi.org/10.1136/bmjopen-2023-074256 |
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author | Khanipour-Kencha, Ali Ghiyasvandian, Shahrzad Mohammadi, Somaye Khabazkhoob, Mehdi Mirshahi, Arvin Wells, Rachel Zakerimoghadam, Masoumeh |
author_facet | Khanipour-Kencha, Ali Ghiyasvandian, Shahrzad Mohammadi, Somaye Khabazkhoob, Mehdi Mirshahi, Arvin Wells, Rachel Zakerimoghadam, Masoumeh |
author_sort | Khanipour-Kencha, Ali |
collection | PubMed |
description | INTRODUCTION: Heart failure (HF) as a long-term clinical syndrome is associated with inadequate self-care behaviours, a feeling of uncertainty and frequent hospitalisation. In recent years, empowerment has evolved for improving chronic disease management. Nevertheless, there is a lack of studies investigating remote care interventions such as a tele-empowerment programme in patients with HF. Therefore, this protocol proposes a randomised controlled trial which aims to evaluate the effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission in patients with HF. METHODS AND ANALYSIS: The study is a double-arm and parallel-group randomised controlled trial in which a 10-week intervention, including 6 weeks of a comprehensive tele-empowerment programme and 4 weeks of follow-up, will be compared with usual care. A total of 96 eligible patients with HF will be recruited and randomly assigned to the intervention or control group. The patients in the intervention group will join virtual groups and receive the five-step tele-empowerment programme through the internet. The primary outcomes include self-care behaviours and uncertainty which will be measured with valid instruments at baseline and 10th week. The secondary outcome is the number of patients’ hospital readmissions and will be assessed at the end of the study. Descriptive statistics will be used to describe variables. According to the types of variables, appropriate statistical tests including two-sample t-tests, Χ(2), analysis of covariance or linear regression will be performed. In addition, standardised intervention effect sizes will be calculated for each outcome. ETHICS AND DISSEMINATION: The trial has been approved by the Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation at Tehran University of Medical Sciences. In this study, written consent will be obtained from all participants. The results will be presented to representative groups and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials (IRCT20100725004443N30). |
format | Online Article Text |
id | pubmed-10414091 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-104140912023-08-11 Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial Khanipour-Kencha, Ali Ghiyasvandian, Shahrzad Mohammadi, Somaye Khabazkhoob, Mehdi Mirshahi, Arvin Wells, Rachel Zakerimoghadam, Masoumeh BMJ Open Nursing INTRODUCTION: Heart failure (HF) as a long-term clinical syndrome is associated with inadequate self-care behaviours, a feeling of uncertainty and frequent hospitalisation. In recent years, empowerment has evolved for improving chronic disease management. Nevertheless, there is a lack of studies investigating remote care interventions such as a tele-empowerment programme in patients with HF. Therefore, this protocol proposes a randomised controlled trial which aims to evaluate the effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission in patients with HF. METHODS AND ANALYSIS: The study is a double-arm and parallel-group randomised controlled trial in which a 10-week intervention, including 6 weeks of a comprehensive tele-empowerment programme and 4 weeks of follow-up, will be compared with usual care. A total of 96 eligible patients with HF will be recruited and randomly assigned to the intervention or control group. The patients in the intervention group will join virtual groups and receive the five-step tele-empowerment programme through the internet. The primary outcomes include self-care behaviours and uncertainty which will be measured with valid instruments at baseline and 10th week. The secondary outcome is the number of patients’ hospital readmissions and will be assessed at the end of the study. Descriptive statistics will be used to describe variables. According to the types of variables, appropriate statistical tests including two-sample t-tests, Χ(2), analysis of covariance or linear regression will be performed. In addition, standardised intervention effect sizes will be calculated for each outcome. ETHICS AND DISSEMINATION: The trial has been approved by the Research Ethics Committee of School of Nursing and Midwifery & Rehabilitation at Tehran University of Medical Sciences. In this study, written consent will be obtained from all participants. The results will be presented to representative groups and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials (IRCT20100725004443N30). BMJ Publishing Group 2023-08-09 /pmc/articles/PMC10414091/ /pubmed/37558436 http://dx.doi.org/10.1136/bmjopen-2023-074256 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Nursing Khanipour-Kencha, Ali Ghiyasvandian, Shahrzad Mohammadi, Somaye Khabazkhoob, Mehdi Mirshahi, Arvin Wells, Rachel Zakerimoghadam, Masoumeh Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial |
title | Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial |
title_full | Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial |
title_fullStr | Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial |
title_full_unstemmed | Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial |
title_short | Effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial |
title_sort | effectiveness of a comprehensive tele-empowerment programme on self-care behaviours, uncertainty and readmission of patients with heart failure: protocol for a randomised controlled trial |
topic | Nursing |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10414091/ https://www.ncbi.nlm.nih.gov/pubmed/37558436 http://dx.doi.org/10.1136/bmjopen-2023-074256 |
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