Effectiveness of a Multifaceted Mobile Health Intervention (Multi-Aid-Package) in Medication Adherence and Treatment Outcomes Among Patients With Hypertension in a Low- to Middle-Income Country: Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND The high prevalence of uncontrolled hypertension in Pakistan is predominantly attributed to poor drug adherence. Mobile phone innovations are cheap, ubiquitous, and culturally acceptable tools for behavioral change. As more than 137 million populations in Pakistan use mobile phones, a suitable mobile health (mHealth) module can be a suitable and effective tool to overcome poor drug adherence. OBJECTIVE This study sought to determine whether a novel mobile health intervention was useful in enhancing adherence to antihypertensive therapy and treatment outcomes among patients with hypertension in a developing country. METHODS A parallel, single-blinded, superiority randomized controlled trial of six months duration recruited 439 hypertensive patients at a public hospital in Pakistan, with poor adherence to antihypertensive therapy and access to smartphones. An innovative multifaceted, mHealth intervention, “Multi-Aid-Package”, based on the Health Belief Model was developed for the intervention group. The novel module contained written, audio & visual reminders, infographics, video clips, educational content, and 24/7 individual support, while the control group only received standard care. The primary outcome was self-reported medication adherence measured using the Self-efficacy for Appropriate Medication Adherence Scale (SEAMS) and pill-counting. The secondary outcome was a systolic blood pressure (SBP) change. Both outcomes were evaluated at the baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. RESULTS Of 439 participants, 423 could complete the study. In the control group, 10 participants were lost to follow-up, while one withdrew his consent. In the intervention group, 6 participants were lost to follow-up. At six months post-intervention, the median SEAMS score was higher in the intervention group (32, IQR 11) compared to the controls (21, IQR 6), and the difference was statistically significant (P<0.001). Within the intervention group, there was also an improvement of 12.5 points between baseline and 6 months (P<0.001). By using the pill-counting method, there was an increase in adherent patients between the intervention and the control groups (difference of 81 patients, P<0.001), as well as within groups (difference of 83 patients; baseline vs 6 months, P<0.001). As for the SBP, between groups, there was a statistically significant difference in SBP of 7mmHg (P<0.001) at 6 months, while within groups, there was a reduction by 4mmHg (P<0.001) within the intervention group, but there was an increase by 3mmHg (P=0.314) in the controls. Overall, the number of patients with uncontrolled hypertension was reduced by 46 patients in the intervention group (baseline vs 6 months), but the controls remained unchanged. The Multi-Aid-Package received a 94.8% acceptability score. CONCLUSIONS The novel “Multi-Aid-Package” is an effective mHealth module in enhancing adherence to medication and treatment outcomes among patients with hypertension in a developing country. CLINICALTRIAL Clinical Trials. gov. NCT04577157