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The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial

BACKGROUND: Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have...

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Autores principales: Daud, Maryam Hannah, Ramli, Anis Safura, Abdul-Razak, Suraya, Isa, Mohamad Rodi, Yusoff, Fakhrul Hazman, Baharudin, Noorhida, Mohamed-Yassin, Mohamed Syarif, Badlishah-Sham, Siti Fatimah, Nikmat, Azlina Wati, Jamil, Nursuriati, Mohd-Nawawi, Hapizah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7130454/
https://www.ncbi.nlm.nih.gov/pubmed/32248825
http://dx.doi.org/10.1186/s13063-020-04237-x
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author Daud, Maryam Hannah
Ramli, Anis Safura
Abdul-Razak, Suraya
Isa, Mohamad Rodi
Yusoff, Fakhrul Hazman
Baharudin, Noorhida
Mohamed-Yassin, Mohamed Syarif
Badlishah-Sham, Siti Fatimah
Nikmat, Azlina Wati
Jamil, Nursuriati
Mohd-Nawawi, Hapizah
author_facet Daud, Maryam Hannah
Ramli, Anis Safura
Abdul-Razak, Suraya
Isa, Mohamad Rodi
Yusoff, Fakhrul Hazman
Baharudin, Noorhida
Mohamed-Yassin, Mohamed Syarif
Badlishah-Sham, Siti Fatimah
Nikmat, Azlina Wati
Jamil, Nursuriati
Mohd-Nawawi, Hapizah
author_sort Daud, Maryam Hannah
collection PubMed
description BACKGROUND: Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour of patients with MetS components (i.e., diabetes or hypertension). However, evidence is lacking in terms of their effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving activation and self-management behaviours among patients with MetS. This paper presents the study protocol. METHODS: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18–60 years with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months, and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurses and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app, strengthening the patient–physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the changes in waist circumference, body mass index, blood pressure, patient physical activity level, eating behaviour, perception of chronic illness care, satisfaction with patient–physician interaction, and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. This includes acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and the intervention’s potential effectiveness. CONCLUSION: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04120779. Registered on 9 October 2019, protocol version 1.
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spelling pubmed-71304542020-04-06 The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial Daud, Maryam Hannah Ramli, Anis Safura Abdul-Razak, Suraya Isa, Mohamad Rodi Yusoff, Fakhrul Hazman Baharudin, Noorhida Mohamed-Yassin, Mohamed Syarif Badlishah-Sham, Siti Fatimah Nikmat, Azlina Wati Jamil, Nursuriati Mohd-Nawawi, Hapizah Trials Study Protocol BACKGROUND: Epidemiological studies conducted in various parts of the world have clearly demonstrated that metabolic syndrome (MetS) is an increasing global health problem, not only in Western societies but also in Asian populations. Web-based and mobile phone-based self-management applications have been proven to be effective in improving self-management behaviour of patients with MetS components (i.e., diabetes or hypertension). However, evidence is lacking in terms of their effectiveness specifically for patients with MetS. The aim of this pilot study is to evaluate the feasibility and potential effectiveness of the EMPOWER-SUSTAIN Self-Management e-Health Intervention in improving activation and self-management behaviours among patients with MetS. This paper presents the study protocol. METHODS: A pilot randomised controlled trial will be conducted in a university primary care clinic. A total of 232 patients aged 18–60 years with MetS will be recruited; 116 will be randomised to receive the EMPOWER-SUSTAIN intervention for 6 months, and another 116 patients will continue with usual care. The EMPOWER-SUSTAIN intervention is a multifaceted chronic disease management strategy based on the Chronic Care Model and persuasive technology theory. It consists of training primary care physicians, nurses and patients to use the EMPOWER-SUSTAIN web-based self-management mobile app, strengthening the patient–physician relationship and reinforcing the use of relevant clinical practice guidelines to guide management and prescribing. The primary outcome is the mean change in patient activation score using the Patient Activation Measure short form Malay version (PAM-13-M) questionnaire. The secondary outcomes include the changes in waist circumference, body mass index, blood pressure, patient physical activity level, eating behaviour, perception of chronic illness care, satisfaction with patient–physician interaction, and perceived absolute 10-year cardiovascular disease risk. Feasibility of implementing the intervention will be evaluated. This includes acceptability of the intervention, estimating the likely rate of participant recruitment and retention, appropriateness of the outcome measures, calculation of sample size, and the intervention’s potential effectiveness. CONCLUSION: To our knowledge, this is the first study in Malaysia that aims to determine the feasibility of a multifaceted e-health intervention, as well as to indicate more useful aspects of this intervention for further exploration in a larger trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04120779. Registered on 9 October 2019, protocol version 1. BioMed Central 2020-04-05 /pmc/articles/PMC7130454/ /pubmed/32248825 http://dx.doi.org/10.1186/s13063-020-04237-x Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Daud, Maryam Hannah
Ramli, Anis Safura
Abdul-Razak, Suraya
Isa, Mohamad Rodi
Yusoff, Fakhrul Hazman
Baharudin, Noorhida
Mohamed-Yassin, Mohamed Syarif
Badlishah-Sham, Siti Fatimah
Nikmat, Azlina Wati
Jamil, Nursuriati
Mohd-Nawawi, Hapizah
The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
title The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
title_full The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
title_fullStr The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
title_full_unstemmed The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
title_short The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
title_sort empower-sustain e-health intervention to improve patient activation and self-management behaviours among individuals with metabolic syndrome in primary care: study protocol for a pilot randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7130454/
https://www.ncbi.nlm.nih.gov/pubmed/32248825
http://dx.doi.org/10.1186/s13063-020-04237-x
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