InterTxt2Heart pilot: A trial to evaluate efficacy of text message to improve adherence to cardiovascular medications in secondary prevention.

Lead Research Organisation: London Sch of Hygiene and Trop Medicine
Department Name: Epidemiology and Population Health

Abstract

In less developed countries cardiovascular diseases (heart diseases and stroke) have a vast deleterious impact at individual and society level.

Patients with cardiovascular diseases can benefit from affordable and effective medications, but only a minority of patients takes the medications, and strategies tested in the past to improve taking of these medications have failed.

Mobile phones are becoming an essential instrument in daily life of people living in less developed countries and therefore have become an ideal "instrument" to deliver interventions to change behaviours, such as taking medications. Previous successes of studies using mobile text messages to improve adherence to HIV-medications provides a strong precedent that this success could be translated to cardiovascular diseases. However, to achieve this, it requires a carefully work on understanding the reasons why people stop taking medications that also considers the local-context.

To date, there are no studies in cardiovascular disease that full fill these criteria. Our long-term aim is to conduct the largest study to evaluate if mobile text messages can be helpful to increase adherence to life-saving cardiovascular medications. As a first step (current proposal), we will be studying reasons for poor adherence to cardiovascular medications using "state of art" psychological strategies co-developed by some of the co-applicants. Then, we will convert this knowledge, on reasons for poor adherence, into short-text messages tailor to the specific needs of patients in order to increase adherence of cardiovascular medications. In a second step (not included in this proposal) we will test under controlled experimental conditions (known as randomized trial) if mobile text messages are useful to increase adherence to cardiovascular medications that decrease blood pressure and the bad-cholesterol as well as making the blood thinner to avoid occlusion of arteries in the heart, brain and extremities.

The study will take place in Colombia, Ghana, and India, representing major geographical areas with different stage of economic development and health care systems. We expect that our wide-coverage of less-developed countries will facilitate a rapid adoption of our intervention (if successful) to other less-developed countries. Our study will inform the World Health Organization initiative on uses of mobile text phone interventions to improve management of chronic conditions such as cardiovascular diseases

Technical Summary

There is strong evidence that in patients with atherosclerotic cardiovascular disease (ACVD) anti-platelet therapy, ACE inhibitors, beta-blockers and statins, are cost-effective in reducing subsequent cardiovascular disease (CVD) events, but only a low proportion of these patients adhere to these medications. Interventions delivered through mobile phones are one of the most promising strategies to increase medication adherence. Our long-term plan is to conduct the largest randomised trial to evaluate the efficacy and safety of short messages services (SMS) on adherence to CVD secondary prevention medications in patients with ACVD. For this proposal the objectives are: (1) Develop an appropriate content of SMS addressing local causes of poor adherence (2) Develop the appropriate trial design needed to evaluate the efficacy & safety of SMS to increase adherence to CVD secondary prevention medications. The study will be conducted in Colombia, Ghana, and India, covering a wide spectrum of regions, with different health systems and likely to differ in determinants for poor adherence to medications. The study will have six phases 1) Understand causes of poor adherence, 2) Identify causes of poor adherence that could be modifiable using behavioral change techniques (BCT) 3) Convert knowledge from BCTs into simple SMS, 4) Understand the patterns of clinical care in each setting, 5) Evaluate the feasibility and acceptability for patient recruitment, and 6) Evaluate the e-platform and instruments involved in the trial. Our study will be essential to inform evidence of mobile text phone interventions to increase adherence in CVD secondary prevention applicable to middle income countries. Finally, we will develop a tool kit describing the process for generation of SMS interventions to improve CVD medication adherence that would be useful to scale up this strategy beyond our own study.

Planned Impact

Cardiovascular diseases are the main cause of death worldwide; most of the cardiovascular premature deaths are preventable and occur in low and middle income countries (LMICs). Although cost-effective medications could reduce cardiovascular disease risk by almost two thirds only 1 in 10 patients living with cardiovascular diseases are taking these medications. Even a modest increase in adherence of these live saving medications with a strategy that is affordable and available worldwide will have a major public health impact.

This proposal aims to develop a mobile-Health intervention, to be tested in a future trial, to improve adherence to cardiovascular medications used in secondary prevention in lower and upper middle income countries where most of the burden of cardiovascular disease lies.

The beneficiaries from this proposal are the academic community, policy-making organization, industry, patients and society.

The study will improve the knowledge of causes for poor adherence of cardiovascular secondary prevention medications and will provide evidence about mHealth interventions to increase adherence. In the process of achieving this, the proposal will show a successful example of a multidisciplinary team with skills cardiovascular research, behavioral sciences, mHealth research, and global health to solve a highly relevant public health problem and at the same time generate capacity building in LMICs needed to scale-up and implement the intervention.

Improving adherence to cardiovascular medications used in secondary prevention is top on the global health agenda and is 1 of only 9 targets from the World Health Organization (WHO) Global Action Plan. Our proposal will impact the ongoing global initiatives from policy decision makers such as WHO and World Heart Federation (WHF). The WHF Roadmap for Secondary Prevention initiative (in which Perel (Co-PI) is involved), provides a general framework to countries to narrow the evidence-care gap in secondary prevention and proposed the use of information and communication technology as a potential solution. The WHO Be Healthy, Be Mobile initiative, in which WHO together with more than 20 LMICs aims to provide support to local government to scale up mHealth interventions for smoking cessation, diabetes and hypertension control. Through collaboration with leaders of this initiative, we expect to increase the reach out of our proposal.

Our study will also inform industry. In recent years industry has recognized the potential of digital technologies such as mobile-phones to improve health, an example of this is increasing numbers of health-related mobile-applications. We consider that knowledge from this proposal on the causes of poor-adherence in less developed countries and the process to construct effective mHealth interventions could be of value to industry involved in digital technologies, but also to industry related to drug/devices manufacturing where improve adherence is being recognized as an "added value" to existing products. In order to explore this benefit, we will use the Technology Transfer Office at LSHTM and UCL-Business to facilitate our interface with industry partners. Previous experience from Casas (Co-PI) on industry-academy collaborations, including biotechnology companies, would be valuable to this aim.
 
Description This development grant was key to develop the proposal and get further funding from Colombia to conduct the largest ever trial on this topic. Resutls of this trial will be ready in the coming months and will provide a robust answer to the question whether SMS increase adherence in this population.
Exploitation Route We already published the protocol of the trial and we have submmiteed the final results which after an initial positive response from reviewers is liketly to be published soon
Sectors Healthcare

 
Description Convocatoria para proyectos de investigación en temáticas priorizadas en salud - 2015
Amount $ 1,270,000,000 (COP)
Organisation Administrative Department of Science, Technology and Innovation (Colciencias) 
Sector Public
Country Colombia
Start 01/2016 
End 01/2019
 
Description NUS Singapore 
Organisation National University of Singapore
Department Saw Swee School of Public Health
Country Singapore 
Sector Academic/University 
PI Contribution Expert advice and comments on study design and methods
Collaborator Contribution Excpert advice and comments on qualitative research
Impact Workshop LSHTM September 2016
Start Year 2016
 
Description Text2PreventCVD Collaboration 
Organisation University of Sydney
Country Australia 
Sector Academic/University 
PI Contribution We have been invited to be part of the the Text2PreventCVD collaboration that is planning a systematic review and individual participant data meta-analysis of text message-based interventions for the prevention of cardiovascular diseases. This is lead by the University of Sydney Australia and we will contributing with the data and analysis of this meta-analysis
Collaborator Contribution Same as my team they will be contributing with trial data and analysis plan of this collaboration
Impact There are not outputs yet of this recently initiated collaboration
Start Year 2021
 
Description Abstract presentation at the 3rd World Congress on Public Health & Nutrition, London UK February 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Abstract presentation at the 3rd World Congress on Public Health & Nutrition, London UK February 2018 title Patient's perception on e-health intervention for improving medications adherence in occlusive arterial disease
Year(s) Of Engagement Activity 2018
 
Description Contributor to the Future health Index Report from Philips 
Form Of Engagement Activity A press release, press conference or response to a media enquiry/interview
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Media (as a channel to the public)
Results and Impact I was interviewed for the Future health Index Report from Philips in particular in relation to the use of technology to improve the care of patients with CVD
Year(s) Of Engagement Activity 2017
URL https://www.futurehealthindex.com/report/2017
 
Description Lecture at the International Health Department , Geneva University 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact A presentation about my current work (including txt2heart) to a group of researchers on international health
Year(s) Of Engagement Activity 2017
 
Description NCDE Course LSHTM February 2017 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Title: Research and policy priorities for CVD: a global perspective
Presentation on the rationale, design and update of TxT2Heart by Dr. Pablo Perel (CI TXT2Heart)
Part of a Non-Communicable Diseases Epidemiology course at LSHTM, London, UK, February 2017
Impact: interest to explore potential collaborations in Mexico
Year(s) Of Engagement Activity 2016
 
Description NCDE Course LSHTM March 2019 - 2020 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Postgraduate students
Results and Impact Title: Research and policy priorities for CVD: a global perspective Presentation on the rationale, design and update of TxT2Heart by Dr. Pablo Perel (CI TXT2Heart) Part of a Non-Communicable Diseases Epidemiology course at LSHTM, London, UK
March 2019 and March 2020
Impact: interest to explore potential collaborations in Mexico
Year(s) Of Engagement Activity 2019,2020
 
Description Presentation Argentina December 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presentation on the rationale, design and update of TxT2Heart by Dr. Pablo Perel (CI TXT2Heart)
Event Title: Innovation and Translational Research
Participating at the International Meeting on Translational Research, Buenos Aires, Argentina, December 2016
Impact: Interest to explore potential collaborations in Argentina
Year(s) Of Engagement Activity 2016
 
Description Presentation Colombia APICSA Puerto Rico October 2016 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Purpose: disseminate findings from qualitative research from the Txt2Heart intervention development phase carried out in Colombia
Year(s) Of Engagement Activity 2016
URL http://www.funveca.org/congreso/es/portada/
 
Description Presentation at 3rd World Congress on Public Health and Nutrition, London UK Feb 2018 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Postgraduate students
Results and Impact Title: Patients' perception on e-health intervention for improving medications adherence in occlusive arterial disease
at 3rd World Congress on Public Health and Nutrition during February 26-28, 2018 in London, UK.
Year(s) Of Engagement Activity 2018
 
Description Presentation at VIII Convenci√≥n intercontinental Hominis, Cuba 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Title: Salud, adherencia y tecnología en enfermedades coronarias,
at VIII Convención intercontinental Hominis, Cuba
Year(s) Of Engagement Activity 2018
 
Description Visit to Singapore (NUS) 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact A meeting to Singapore to explore further collaboration with a related project on mhealth in general and the increase of adherence for secondary prevention in particular
Year(s) Of Engagement Activity 2018
 
Description Workshop LSHTM September 2016 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact Workshop title: "Adherence to treatment for chronic conditions: methodological challenges, a multidisciplinary workshop"
Location: London (UK); Date: 21/09/2016
Organised by the LSHTM Centre for Global NCDs
General aims of the workshop: To discuss methodological challenges, incorporating insights from different disciplines, through presentations of adherence-related research projects for different conditions. To identify gaps and a research agenda for the adherence research field.
Txt2Heart-specific aim of the workshop: Presentation on the rationale, design and update of TxT2Heart by Dr. Pablo Perel (CI TXT2Heart)
Outcomes: About 50 people registered to attend from LSHTM and other institutions. There was interest in forming an interest group on adherence
Year(s) Of Engagement Activity 2016