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

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

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.

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.