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Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation
BACKGROUND: We performed a trial to evaluate the efficacy of a blended intervention with personalized health coaching and virtual cardiac rehabilitation to improve medication adherence and risk factors. The trial was terminated early. Here, we describe findings from a root cause analysis and lessons...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8890340/ https://www.ncbi.nlm.nih.gov/pubmed/35265897 http://dx.doi.org/10.1016/j.cvdhj.2021.01.003 |
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author | Olivier, Christoph B. Middleton, Stephanie K. Purington, Natasha Shashidhar, Sumana Hereford, Jody Mahaffey, Kenneth W. Turakhia, Mintu P. |
author_facet | Olivier, Christoph B. Middleton, Stephanie K. Purington, Natasha Shashidhar, Sumana Hereford, Jody Mahaffey, Kenneth W. Turakhia, Mintu P. |
author_sort | Olivier, Christoph B. |
collection | PubMed |
description | BACKGROUND: We performed a trial to evaluate the efficacy of a blended intervention with personalized health coaching and virtual cardiac rehabilitation to improve medication adherence and risk factors. The trial was terminated early. Here, we describe findings from a root cause analysis and lessons learned. METHODS: SmartGUIDE was an open-label, single-center trial that randomized participants with coronary artery disease who were prescribed a statin and/or P2Y12 inhibitor 1:1 to either usual care or the added use of a mobile app with components of cardiac rehabilitation paired with personal virtual coaching. The primary outcome was medication adherence: proportion of days covered (PDC). The planned sample size was 132. We performed a root cause analysis to evaluate processes from study development to closure. RESULTS: During trial conduct, the technology start-up withdrew the intervention. The study was terminated early with 63 participants randomized and data from 26 available for analysis. The median PDC was high in both groups (intervention group 94%, interquartile range [IQR] 88%–96%; control group: 99%, IQR 95%–100%). Root cause analysis identified factors for not achieving trial objectives: key factors that limited enrollment (inclusion criteria, low penetration of compatible smartphones), participant retention or engagement (poor app product, insufficient technology support), and suboptimal choice of a technology partner (technology start-up’s inexperience in health care, poor product design, inadequate fundraising). CONCLUSION: We identified important and preventable factors leading to trial failure. These factors may be common across digital health trials and may explain prior observations that many such trials are never completed. Careful vetting of technology partners and more pragmatic study designs may prevent these missteps. |
format | Online Article Text |
id | pubmed-8890340 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-88903402022-03-08 Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation Olivier, Christoph B. Middleton, Stephanie K. Purington, Natasha Shashidhar, Sumana Hereford, Jody Mahaffey, Kenneth W. Turakhia, Mintu P. Cardiovasc Digit Health J Clinical BACKGROUND: We performed a trial to evaluate the efficacy of a blended intervention with personalized health coaching and virtual cardiac rehabilitation to improve medication adherence and risk factors. The trial was terminated early. Here, we describe findings from a root cause analysis and lessons learned. METHODS: SmartGUIDE was an open-label, single-center trial that randomized participants with coronary artery disease who were prescribed a statin and/or P2Y12 inhibitor 1:1 to either usual care or the added use of a mobile app with components of cardiac rehabilitation paired with personal virtual coaching. The primary outcome was medication adherence: proportion of days covered (PDC). The planned sample size was 132. We performed a root cause analysis to evaluate processes from study development to closure. RESULTS: During trial conduct, the technology start-up withdrew the intervention. The study was terminated early with 63 participants randomized and data from 26 available for analysis. The median PDC was high in both groups (intervention group 94%, interquartile range [IQR] 88%–96%; control group: 99%, IQR 95%–100%). Root cause analysis identified factors for not achieving trial objectives: key factors that limited enrollment (inclusion criteria, low penetration of compatible smartphones), participant retention or engagement (poor app product, insufficient technology support), and suboptimal choice of a technology partner (technology start-up’s inexperience in health care, poor product design, inadequate fundraising). CONCLUSION: We identified important and preventable factors leading to trial failure. These factors may be common across digital health trials and may explain prior observations that many such trials are never completed. Careful vetting of technology partners and more pragmatic study designs may prevent these missteps. Elsevier 2021-02-09 /pmc/articles/PMC8890340/ /pubmed/35265897 http://dx.doi.org/10.1016/j.cvdhj.2021.01.003 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). |
spellingShingle | Clinical Olivier, Christoph B. Middleton, Stephanie K. Purington, Natasha Shashidhar, Sumana Hereford, Jody Mahaffey, Kenneth W. Turakhia, Mintu P. Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation |
title | Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation |
title_full | Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation |
title_fullStr | Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation |
title_full_unstemmed | Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation |
title_short | Why digital health trials can fail: Lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation |
title_sort | why digital health trials can fail: lessons learned from a randomized trial of health coaching and virtual cardiac rehabilitation |
topic | Clinical |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8890340/ https://www.ncbi.nlm.nih.gov/pubmed/35265897 http://dx.doi.org/10.1016/j.cvdhj.2021.01.003 |
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