HIGHLIGHTS
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There are limited data on the value of digital health interventions.
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Elfie is a free app with a set of features for hypertension management.
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Elfie is designed to enhance self-monitoring, adherence and education.
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This study assesses the Elfie in adults with hypertension.
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Elfie could offer a low-cost app for hypertension management globally.
ABSTRACT
Background
Hypertension represents a major contributor to the global cardiovascular (CV) disease burden, yet it remains inadequately controlled largely due to poor treatment adherence. Emerging digital health technologies hold promise for improving blood pressure (BP) management and CV outcomes, but the lack of evidence, unavailability in most countries, and out-of-pocket costs have hindered the widespread use of these technologies in clinical practice.
Objectives
To assess in a randomized controlled trial whether a digital health intervention (DHI) based on the free Elfie solution compared to usual care will reduce systolic blood pressure (SBP) in adults with uncontrolled hypertension (SBP ≥ 140 mmHg).
Methods
This is a pragmatic, open-label, randomized parallel arm, international, multicenter clinical trial. Adult individuals with hypertension are randomly assigned to usual care or a DHI based on the Elfie solution. Elfie offers a comprehensive set of features designed to enhance self-monitoring, adherence and education, complemented with a gamification feature to boost engagement. The primary outcome is office SBP measured at 6 months. Secondary outcomes include medication adherence, diastolic BP, BP control achievement, hypertension knowledge, self-care, health-related quality of life and process outcomes assessing app usage and engagement.
Conclusions
The ELFIE-HYPERTENSION trial is an international multicenter pragmatic randomized clinical trial, investigating the effects of an innovative, free and scalable DHI to improve BP control. If proven effective, this intervention can be easily and widely implemented in the management of hypertension in a variety of clinical settings globally.
Trial registration number
The trial is registered at the Clinicaltrials.gov (NCT06242483).
Background and rationale
Hypertension remains the leading modifiable risk factor for premature all-cause and cardiovascular (CV) deaths, accounting for 10.8 million CV deaths in 2021. CV disease morbidity and mortality are primarily driven by ischemic heart disease and stroke, both of which are mainly related to poor blood pressure (BP) control worldwide.
Despite major advances in hypertension treatments, adherence to lifestyle changes and antihypertensive medications is frequently suboptimal, as more than 50% of individuals with hypertension are considered nonadherent. , Therapeutic inertia, poor adherence and insufficient patient engagement are associated with uncontrolled BP and adverse CV outcomes. , Recognizing this, national and international guidelines emphasize the importance of screening for poor adherence in patients with hypertension and recommend tools to support treatment adherence. ,,, Moreover, many patients lack sufficient knowledge about hypertension, a critical factor for sustaining long-term engagement and adherence to an effective healthcare management. In view of these challenges, innovative solutions are needed to improve BP control and patient engagement.
Recently, several digital health interventions (DHIs) have shown the capability of improving quality of care, clinical outcomes, reduce healthcare-related costs and improve patient satisfaction in CV diseases management. , DHIs include a wide range of technologies such as telemonitoring devices, decision support platforms, and mobile health apps (mHealth). mHealth technology is one of the most promising DHI since 7.33 billion people are estimated to have mobile phones in the world and 4.64 billion people are estimated to have a smartphone globally. To date, few of these technologies have been rigorously tested in dedicated randomized clinical trials (RCTs) and evidence on multifeature DHIs in hypertension remains limited, especially in low-middle income countries, which account for nearly 80% of the global hypertensive population. ,,, In addition, the regulatory requirements and high operational costs of such technologies may result in the absence of digital solutions in many countries or in inaccessibility of these solutions because of out-of-pocket expenses for patients. All these constraints have hindered the widespread use of digital technologies in clinical practice.
A previous review has also shown a high attrition rate of app usage, with 70% of users discontinuing use of health apps within the first 100 days. Other reviews have also found high attrition rates, but these studies analyzed health apps mainly related to mental health and mindfulness, physical activity and smoking, ,,, thus, strategies to improve app engagement, such as gamification, need to be considered in app development. Therefore, there is a need to better understand user engagement over time with health apps related to CV diseases management, especially in apps with engagement strategies such as gamification, and its association with clinical outcomes.
In 2021, the digital Elfie solution was launched to address challenges in the management of chronic conditions, such as hypertension and diabetes, by improving patient adherence, knowledge, and engagement. The Elfie app is a free, user-friendly digital technology, widely available in most countries, with several features to facilitate hypertension management, including a novel gamification feature to improve user engagement. This gamification feature is a reward-based scoring system that encourages self-monitoring through the performance of tasks assigned in the personalized app monitoring plan.
In summary, mHealth apps are promising tools to improve BP control, through features aimed at improving medication adherence, self-monitoring and patient education; however, there is a lack of high-quality evidence through RCTs investigating the effects of such apps in hypertension management, especially in low-middle income countries and utilizing mHealth apps equipped with gamification features aimed at improving user engagement and reducing user attrition rates. Therefore, the ELFIE-HYPERTENSION trial is designed to evaluate the efficacy of the novel Elfie app-based solution in improving hypertension control in a low-middle income setting.
Methods
Study design, setting, and organization
The ELFIE-HYPERTENSION trial is an international, multicenter, pragmatic, open-label, randomized (concealed) trial with parallel groups (2-arms). In this trial, the outcome assessor is unaware of treatment assignments, and the primary analysis follows the intention-to-treat principle. The total follow-up period is 6 months ( Figure 1 ). The study is being conducted in 16 research sites (11 in Brazil and 5 in Vietnam) comprising outpatient clinics in public, private and teaching hospitals, as well as private practices in Brazil and Vietnam. Participating sites include primary, secondary and tertiary levels of care. The trial is registered at the Clinicaltrials.gov (NCT06242483). The study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement.
ELFIE-HYPERTENSION design and flowchart.
SBP, systolic blood pressure.
Study objectives
The primary objective of the ELFIE-HYPERTENSION trial is to evaluate whether a DHI based on the Elfie solution compared to usual care provides a greater reduction in the systolic BP (SBP) at 6 months in adults with hypertension. The secondary objectives are to assess whether this DHI compared to usual care improves diastolic BP (DBP), BP control achievement, adherence to antihypertensive medication, antihypertensive treatment intensification, body mass index (BMI), hypertension knowledge, self-care, health-related quality of life, and the need for unscheduled CV-related medical assessment. We also aim to assess the app user engagement and satisfaction through process outcomes on the app usage data and user feedback surveys.
Study population and recruitment
Adults with a previous diagnosis of hypertension with currently uncontrolled systolic BP (office SBP ≥ 140 mmHg) are screened to participate. Ownership of a compatible smartphone and the ability to operate a smartphone app are required for the participant to be enrolled into the trial, given the DHI being evaluated. Detailed inclusion and exclusion criteria are presented in Table 1 . Potential participants are screened at research sites and invited to participate in the study if they meet the eligibility criteria. Upon agreeing to participate, individuals are required to provide written informed consent. Reasons for ineligibility are registered for screened individuals. Recruitment strategies for this study are based on nonprobability consecutive/convenience sampling including potential participant identification through review of the local practice´s medical records and previous studies´ databases, screening outpatient clinic case lists or referrals from other physicians and social media advertisements.
Table 1
Eligibility criteria.
| Inclusion criteria |
| 1. Age ≥ 18 years and ≤ 75 years |
| 2. Male or female |
| 3. Hypertension diagnosis based on the local guidelines criteria |
| 4. Uncontrolled BP (SBP ≥ 140 mmHg) on the screening visit |
| 5. Patients in whom medication adherence needs to be improved according to the healthcare provider clinical judgment |
| 6. Use of at least 1 anti-hypertensive medication |
| 7. Ownership of an active smartphone with operational system iOS (version 13.0 or later) or Android (version 8.0 or later) with access to the internet on 3G, 4G or 5G |
| 8. Ability to use a mobile phone app |
| Exclusion criteria |
| 1. Unable to provide written informed consent |
| 2. Current use of a health app with the aim to improve medication adherence and BP control |
| 3. Illiteracy to read in the local language |
| 4. Known cognitive decline, dementia, or diagnosis of severe psychiatric conditions (depression, schizophrenia, bipolar disorder) |
| 5. Known use of illicit drugs or alcoholism |
| 6. Current participation in a cardiovascular randomized clinical trial |
| 7. Life expectancy < 1 year |
BP , blood pressure; SBP , systolic blood pressure.
Randomization, group allocation and blinding
Eligible participants who provide written informed consent are randomized in a 1:1 ratio to the DHI group (Elfie solution) or to the usual care group. The randomization sequence is generated using a statistical software with variable block sizes and is stratified by site, age (< and ≥ 50 years) and ownership of a BP monitor (yes/no). Randomization is implemented with the use of a central concealed, web-based, automated randomization system, preventing selection bias during enrolment.
Due to the nature of the intervention, blinding of participants and study personnel implementing the intervention is not possible in this study, therefore, the trial is considered open label. However, the primary outcome assessor is unaware of treatment assignments. Therefore, all research sites are instructed to appoint a member, not involved in the randomization process, to conduct the follow-up visit and collect the primary outcome data. Additionally, participants are also requested not to disclose their allocated group prior to outcome assessment.
Interventions
Participants randomized to usual care receive standard care, in which hypertension treatment is provided according to hypertension guideline recommendations, including nonpharmacological and pharmacological treatment. Standard care is implemented by investigators according to their local practices, without any study protocol-specific guidance on BP management other than participants being instructed not to access/use other mobile phone apps or participate in any kind of DHI related to hypertension treatment during the trial. Additionally, they do not have access to the Elfie solution.
Participants randomized to DHI group receive standard care plus the Elfie solution. The Elfie solution is designed to improve knowledge, adherence, and the quality of care for patients with CV diseases (CVD). The Elfie solution comprises a smartphone app with the following features related to hypertension ( Figure 2 ):
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Personalized monitoring plan based on health conditions to guide frequency of monitoring of BP, weight, and step count. The monitoring plan is designed by the physician together with the participant during the baseline/randomization visit.
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Digital pillbox with daily medication-taking reminders and refill reminders.
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Clinical measurements graphs for BP, weight, medication adherence and step count.
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Newsfeed with short videos and texts related to CVD risk factors, diagnosis, and treatment.
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Digital coach—Artificial intelligence technology that provides information via a chatbox as well as feedback information regarding the adherence to the monitoring plan via personalized videos. This feature does not provide medical advice.
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Connection with a health app or wearable, such as smartwatches, for step count.
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Possibility of family peer support, in which a family member can have access to the participant´s app information.
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Gamification through the Elfie rewards scoring system—A rewards scoring system, in which participants earn points when performing the monitoring plan tasks related to hypertension treatment. The earned points can be exchanged for discounts on products from partners of the Elfie solution.
Overview of Elfie Solution main features.
Screenshots of the Elfie Solution main features: (A) Health plan, (B) Digital pillbox, (C) Coaching center, (D) Gamification.
Participants randomized to the Elfie solution are instructed to download the Elfie app and receive training on how to register in the app and on how to use all the app features. The research site medical team creates a personalized monitoring plan for each participant and instruct them to use the app according to the monitoring plan for the following 6 months. A call with an app customer support service directly within the app is available if any technical difficulty or questions regarding the Elfie app are encountered. The app usage during the course of the study is centrally monitored and participants may be contacted by the research team to encourage the use of the Elfie app if low engagement with the app is noted during the study conduct.
All research site staff are trained by the Elfie team on the app’s features to effectively support participants. If needed, the research site staff can contact the Elfie team for assistance with any technical issues. The Elfie app is freely available in the app stores, every participant will use a research version of the app, which has the same features of the commercially available app version but includes specific codes for each site and participant to ensure data tracking by the data management team. After the follow-up period ends, participants will be logged out of the research version of the app but can continue using the commercially available app version without data tracking.
Study outcomes
Study outcomes are collected at the 6-month follow-up visit by a research site member who is unaware of treatment assignments. Outcomes of the ELFIE-HYPERTENSION trial are listed in Table 2 . The primary outcome is office SBP measured at the 6-month follow-up visit. Secondary outcomes are specified in Table 2 .
Table 2
Study outcomes.
| Primary outcome |
| Office SBP |
| Secondary outcomes |
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BMI , body mass index; CV , cardiovascular; DBP , diastolic blood pressure; HK-LS , Hypertension Knowledge-level scale; MMAS , Morisky Medication Adherence Scale; SBP , systolic blood pressure; SC HI , Self-care of Hypertension Inventory; SF-12 , Short form 12.
We will also measure process outcomes to determine the level of app engagement and satisfaction of the intervention participants with the Elfie app ( Table 3 ) through the collection of app usage data and user feedback surveys.
Table 3
Process outcomes.
| Process outcomes related to the app usage |
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| Process outcomes related to the BP monitoring |
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| Process outcomes related to the medications |
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| Process outcomes related to the other features |
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