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.

Background: The high prevalence of uncontrolled hypertension in Pakistan is predominantly attributed to poor medication adherence. As more than 137 million people in Pakistan use cell phones, a suitable mobile health (mHealth) intervention can be an effective tool to overcome poor medication adherence.

Objective: We sought to determine whether a novel mHealth intervention is useful in enhancing antihypertensive therapy adherence and treatment outcomes among patients with hypertension in a low- to middle-income country.

Methods: A 6-month parallel, single-blinded, superiority randomized controlled trial recruited 439 patients with hypertension with poor adherence to antihypertensive therapy and access to smartphones. An innovative, multifaceted mHealth intervention (Multi-Aid-Package), based on the Health Belief Model and containing reminders (written, audio, visual), infographics, video clips, educational content, and 24/7 individual support, was developed for the intervention group; the control group 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 systolic blood pressure (SBP) change. Both outcomes were evaluated at baseline and 6 months. Technology acceptance feedback was also assessed at the end of the study. A generalized estimating equation was used to control the covariates associated with the probability of affecting adherence to antihypertensive medication.

Results: Of 439 participants, 423 (96.4%) completed the study. At 6 months post intervention, the median SEAMS score was statistically significantly higher in the intervention group compared to the controls (median 32, IQR 11 vs median 21, IQR 6; U=10,490, P<.001). Within the intervention group, there was an increase in the median SEAMS score by 12.5 points between baseline and 6 months (median 19.5, IQR 5 vs median 32, IQR 11; P<.001). Results of the pill-counting method showed an increase in adherent patients in the intervention group compared to the controls (83/220, 37.2% vs 2/219, 0.9%; P<.001), as well as within the intervention group (difference of n=83, 37.2% of patients, baseline vs 6 months; P<.001). There was a statistically significant difference in the SBP of 7 mmHg between the intervention and control groups (P<.001) at 6 months, a 4 mmHg reduction (P<.001) within the intervention group, and a 3 mmHg increase (P=.314) within the controls. Overall, the number of patients with uncontrolled hypertension decreased by 46 in the intervention group (baseline vs 6 months), but the control group remained unchanged. The variables groups (adjusted odds ratio [AOR] 1.714, 95% CI 2.387-3.825), time (AOR 1.837, 95% CI 1.625-2.754), and age (AOR 1.618, 95% CI 0.225-1.699) significantly contributed (P<.001) to medication adherence. Multi-Aid-Package received a 94.8% acceptability score.

Conclusions: The novel Multi-Aid-Package is an effective mHealth intervention for enhancing medication adherence and treatment outcomes among patients with hypertension in a low- to middle-income country.

Trial registration: ClinicalTrials.gov NCT04577157; https://clinicaltrials.gov/study/NCT04577157.