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Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial

BACKGROUND: Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and pre...

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Autores principales: Maddison, Ralph, Stewart, Ralph, Doughty, Rob, Scott, Tony, Kerr, Andrew, Benatar, Jocelyne, Whittaker, Robyn, Rawstorn, Jonathan C., Rolleston, Anna, Jiang, Yannan, Estabrooks, Paul, Sullivan, Rachel Karen, Bartley, Hannah, Pfaeffli Dale, Leila
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785898/
https://www.ncbi.nlm.nih.gov/pubmed/29370829
http://dx.doi.org/10.1186/s13063-018-2468-z
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author Maddison, Ralph
Stewart, Ralph
Doughty, Rob
Scott, Tony
Kerr, Andrew
Benatar, Jocelyne
Whittaker, Robyn
Rawstorn, Jonathan C.
Rolleston, Anna
Jiang, Yannan
Estabrooks, Paul
Sullivan, Rachel Karen
Bartley, Hannah
Pfaeffli Dale, Leila
author_facet Maddison, Ralph
Stewart, Ralph
Doughty, Rob
Scott, Tony
Kerr, Andrew
Benatar, Jocelyne
Whittaker, Robyn
Rawstorn, Jonathan C.
Rolleston, Anna
Jiang, Yannan
Estabrooks, Paul
Sullivan, Rachel Karen
Bartley, Hannah
Pfaeffli Dale, Leila
author_sort Maddison, Ralph
collection PubMed
description BACKGROUND: Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand. METHODS: Text4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention. DISCUSSION: The Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426. Registered retrospectively on 1 April 2016.  ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2468-z) contains supplementary material, which is available to authorized users.
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spelling pubmed-57858982018-02-07 Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial Maddison, Ralph Stewart, Ralph Doughty, Rob Scott, Tony Kerr, Andrew Benatar, Jocelyne Whittaker, Robyn Rawstorn, Jonathan C. Rolleston, Anna Jiang, Yannan Estabrooks, Paul Sullivan, Rachel Karen Bartley, Hannah Pfaeffli Dale, Leila Trials Study Protocol BACKGROUND: Cardiac rehabilitation (CR) is an essential component of contemporary management for patients with coronary heart disease, including following an acute coronary syndrome (ACS). CR typically involves education and support to assist people following an ACS to make lifestyle changes and prevent subsequent events. Despite its benefits, uptake and participation in tradition CR programs is low. The use of mobile technologies (mHealth) offers the potential to improve reach, access, and delivery of CR support. We aim to determine the effectiveness and cost-effectiveness of a text-messaging intervention (Text4Heart II) to improve adherence to medication and lifestyle change in addition to usual care in people following an ACS. A second aim is to use the RE-AIM framework to inform the potential implementation of Text4Heart II within health services in New Zealand. METHODS: Text4Heart II is a two-arm, parallel, superiority randomized controlled trial conducted in two large metropolitan hospitals in Auckland, New Zealand. Three hundred and thirty participants will be randomized to either a 24-week theory- and evidence-based personalized text message program to support self-management in addition to usual CR, or usual CR alone (control). Outcomes are assessed at 6 and 12 months. The primary outcome is the proportion of participants adhering to medication at 6 months as measured by dispensed records. Secondary outcomes include medication adherence at 12 months, the proportion of participants adhering to self-reported healthy behaviors (physical activity, fruit and vegetable consumption, moderating alcohol intake and smoking status) measured using a composite health behavior score, self-reported medication adherence, cardiovascular risk factors (lipids, blood pressure), readmissions and related hospital events at 6 and 12 months. A cost-effectiveness analysis will also be conducted. Using the RE-AIM framework, we will determine uptake and sustainability of the intervention. DISCUSSION: The Text4Heart II trial will determine the effectiveness of a text-messaging intervention to improve adherence to medication and lifestyle behaviors at both 6 and 12 months. Using the RE-AIM framework this trial will provide much needed data and insight into the potential implementation of Text4Heart II. This trial addresses many limitations/criticisms of previous mHealth trials; it builds on our Text4Heart pilot trial, it is adequately powered, has sufficient duration to elicit behavior change, and the follow-up assessments (6 and 12 months) are long enough to determine the sustained effect of the intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ID: ACTRN12616000422426. Registered retrospectively on 1 April 2016.  ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-018-2468-z) contains supplementary material, which is available to authorized users. BioMed Central 2018-01-25 /pmc/articles/PMC5785898/ /pubmed/29370829 http://dx.doi.org/10.1186/s13063-018-2468-z Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. 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.
spellingShingle Study Protocol
Maddison, Ralph
Stewart, Ralph
Doughty, Rob
Scott, Tony
Kerr, Andrew
Benatar, Jocelyne
Whittaker, Robyn
Rawstorn, Jonathan C.
Rolleston, Anna
Jiang, Yannan
Estabrooks, Paul
Sullivan, Rachel Karen
Bartley, Hannah
Pfaeffli Dale, Leila
Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
title Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
title_full Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
title_fullStr Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
title_full_unstemmed Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
title_short Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
title_sort text4heart ii – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5785898/
https://www.ncbi.nlm.nih.gov/pubmed/29370829
http://dx.doi.org/10.1186/s13063-018-2468-z
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