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Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial

BACKGROUND: Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract t...

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Autores principales: Claes, Jomme, Cornelissen, Véronique, McDermott, Clare, Moyna, Niall, Pattyn, Nele, Cornelis, Nils, Gallagher, Anne, McCormack, Ciara, Newton, Helen, Gillain, Alexandra, Budts, Werner, Goetschalckx, Kaatje, Woods, Catherine, Moran, Kieran, Buys, Roselien
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055834/
https://www.ncbi.nlm.nih.gov/pubmed/32014842
http://dx.doi.org/10.2196/14221
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author Claes, Jomme
Cornelissen, Véronique
McDermott, Clare
Moyna, Niall
Pattyn, Nele
Cornelis, Nils
Gallagher, Anne
McCormack, Ciara
Newton, Helen
Gillain, Alexandra
Budts, Werner
Goetschalckx, Kaatje
Woods, Catherine
Moran, Kieran
Buys, Roselien
author_facet Claes, Jomme
Cornelissen, Véronique
McDermott, Clare
Moyna, Niall
Pattyn, Nele
Cornelis, Nils
Gallagher, Anne
McCormack, Ciara
Newton, Helen
Gillain, Alexandra
Budts, Werner
Goetschalckx, Kaatje
Woods, Catherine
Moran, Kieran
Buys, Roselien
author_sort Claes, Jomme
collection PubMed
description BACKGROUND: Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. OBJECTIVE: The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. METHODS: Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients’ experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). RESULTS: A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; P(interaction)=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; P(interaction)=.004; effect size of −0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; P(interaction)=.004; effect size of −0.36) remained constant, but deteriorated in UC. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. TRIAL REGISTRATION: ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-016781
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spelling pubmed-70558342020-03-16 Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial Claes, Jomme Cornelissen, Véronique McDermott, Clare Moyna, Niall Pattyn, Nele Cornelis, Nils Gallagher, Anne McCormack, Ciara Newton, Helen Gillain, Alexandra Budts, Werner Goetschalckx, Kaatje Woods, Catherine Moran, Kieran Buys, Roselien J Med Internet Res Original Paper BACKGROUND: Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. OBJECTIVE: The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. METHODS: Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients’ experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). RESULTS: A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; P(interaction)=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; P(interaction)=.004; effect size of −0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; P(interaction)=.004; effect size of −0.36) remained constant, but deteriorated in UC. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. TRIAL REGISTRATION: ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-016781 JMIR Publications 2020-02-04 /pmc/articles/PMC7055834/ /pubmed/32014842 http://dx.doi.org/10.2196/14221 Text en ©Jomme Claes, Véronique Cornelissen, Clare McDermott, Niall Moyna, Nele Pattyn, Nils Cornelis, Anne Gallagher, Ciara McCormack, Helen Newton, Alexandra Gillain, Werner Budts, Kaatje Goetschalckx, Catherine Woods, Kieran Moran, Roselien Buys. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 04.02.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Claes, Jomme
Cornelissen, Véronique
McDermott, Clare
Moyna, Niall
Pattyn, Nele
Cornelis, Nils
Gallagher, Anne
McCormack, Ciara
Newton, Helen
Gillain, Alexandra
Budts, Werner
Goetschalckx, Kaatje
Woods, Catherine
Moran, Kieran
Buys, Roselien
Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial
title Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial
title_full Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial
title_fullStr Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial
title_full_unstemmed Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial
title_short Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial
title_sort feasibility, acceptability, and clinical effectiveness of a technology-enabled cardiac rehabilitation platform (physical activity toward health-i): randomized controlled trial
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7055834/
https://www.ncbi.nlm.nih.gov/pubmed/32014842
http://dx.doi.org/10.2196/14221
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