Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol
Introduction Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidenc...
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BMJ Publishing Group
2019-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/12/e028017.full |
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| author | Elizabeth Murray David Prieto-Merino Pablo Perel Louise Atkins Caroline Free Robert Horne Juan P Casas Anderson Bermon Ana Fernanda Uribe-Rodríguez Paula Fernanda Pérez-Rivero Diana Isabel Cáceres Rivera Elizabeth Guio Norma Cecilia Serrano Díaz |
| author_facet | Elizabeth Murray David Prieto-Merino Pablo Perel Louise Atkins Caroline Free Robert Horne Juan P Casas Anderson Bermon Ana Fernanda Uribe-Rodríguez Paula Fernanda Pérez-Rivero Diana Isabel Cáceres Rivera Elizabeth Guio Norma Cecilia Serrano Díaz |
| author_sort | Elizabeth Murray |
| collection | DOAJ |
| description | Introduction Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients.Methods and analysis The txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11-dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease.Ethics and dissemination The study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population.Trial registration number NCT03098186. |
| format | Article |
| id | doaj-art-af0eae9b593b444b82ab39c7f2bd089a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-af0eae9b593b444b82ab39c7f2bd089a2024-12-03T14:45:09ZengBMJ Publishing GroupBMJ Open2044-60552019-12-0191210.1136/bmjopen-2018-028017Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocolElizabeth Murray0David Prieto-Merino1Pablo Perel2Louise Atkins3Caroline Free4Robert Horne5Juan P Casas6Anderson Bermon7Ana Fernanda Uribe-Rodríguez8Paula Fernanda Pérez-Rivero9Diana Isabel Cáceres Rivera10Elizabeth Guio11Norma Cecilia Serrano Díaz12Research Department of Primary Care and Population Health, University College London, London, UKClinical Trials Unit, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UKDepartment of Population Health, London School of Hygiene and Tropical Medicine, London, UKUniversity College London Research Department of Epidemiology and Public Health, London, UKPopulation Health, London School of Hygiene and Tropical Medicine, London, London, UK1 Centre for Behavioural Medicine, University College London, London, UKFaculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, WC1E 7HT, UKResearch, Fundacion Cardiovascular de Colombia, Floridablanca, Santander, ColombiaFaculty of Psychology, Universidad Pontificia Bolivariana - Seccional Bucaramanga, Floridablanca, Santander, ColombiaFaculty of Psychology, Universidad Pontificia Bolivariana - Seccional Bucaramanga, Floridablanca, Santander, ColombiaNursing, Universidad Cooperativa de Colombia, Bucaramanga, Santander, ColombiaMetabolism and Genoma Laboratory, Fundacion Cardiovascular de Colombia, Floridablanca, Santander, ColombiaDirection of Research, Fundación Cardiovascular de Colombia, Bucaramanga, Santander, ColombiaIntroduction Anti-platelet therapy, angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers, beta-blockers and statins are cost-effective in patients with atherosclerotic cardiovascular diseases (ASCVD) for reducing the risk of ASCVD events. Unfortunately, there is abundant evidence that adherence to these cardiovascular medications is far from ideal. A recent Cochrane review showed a potential beneficial effect of Short Message Service (SMS) interventions on adherence to medication in ASCVD patients.Methods and analysis The txt2heart study is a pragmatic randomised single-blind controlled trial. The objective is to evaluate the efficacy and safety of an intervention with SMS messages delivered by mobile phones to improve adherence to cardiovascular medications in patients with ASCVD. The intervention consists of behavioural techniques delivered via SMS. The primary outcome is change in blood serum low-density lipoprotein cholesterol levels as an indicator of adherence to statins. Secondary outcomes will include systolic blood pressure as an indicator of adherence to blood-lowering therapies and heart rate as an indicator of adherence to beta-blockers, urine levels of 11-dehydrothromboxane B2, self-reported adherence to cardiovascular medications and rates of cardiovascular death or hospitalisation due to cardiovascular disease.Ethics and dissemination The study will be performed in compliance with the protocol, regulatory requirements, Good Clinical Practice and ethical principles of the Declaration of Helsinki. The Ethics Committee of Fundación Cardiovascular de Colombia evaluated and approved the trial. The txt2heart Colombia trial aims to provide robust evidence to evaluate whether SMS messages delivered through mobile telephones change the behaviour of Colombian patients who have suffered a cardiovascular event. Trial results will be presented to the local health authorities, and if the intervention is effective and safe, we hope this strategy will be implemented quickly because of its low cost and wide-reaching impact on the population.Trial registration number NCT03098186.https://bmjopen.bmj.com/content/9/12/e028017.full |
| spellingShingle | Elizabeth Murray David Prieto-Merino Pablo Perel Louise Atkins Caroline Free Robert Horne Juan P Casas Anderson Bermon Ana Fernanda Uribe-Rodríguez Paula Fernanda Pérez-Rivero Diana Isabel Cáceres Rivera Elizabeth Guio Norma Cecilia Serrano Díaz Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol BMJ Open |
| title | Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol |
| title_full | Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol |
| title_fullStr | Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol |
| title_full_unstemmed | Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol |
| title_short | Evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention: the txt2heart Colombia randomised controlled trial protocol |
| title_sort | evaluation of the efficacy and safety of text messages targeting adherence to cardiovascular medications in secondary prevention the txt2heart colombia randomised controlled trial protocol |
| url | https://bmjopen.bmj.com/content/9/12/e028017.full |
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