JMIR Publications

ABSTRACT

Background:

Recent research has underscored the need to develop socio-culturally tailored interventions to improve adherence behaviors in minority patients with hypertension (HTN) and type II diabetes (T2D). Novel eHealth approaches is one potential method for delivering tailored interventions to minority patients with increased cardiovascular risk.

Objective:

To develop and evaluate the feasibility, acceptability and preliminary efficacy of a tailored eHealth adherence intervention vs. an attention control (AC) on medication adherence, systolic and diastolic blood pressure (SBP and DBP) and hemoglobin A1c (HbA1c) in 42 Black patients with uncontrolled HTN and/or T2D, who were initially non-adherent to their medications.

Methods:

This was a two-phase pilot study consisting of a formative phase and a clinical-efficacy phase. The formative phase consisted of qualitative interviews with 10 members of the target patient population to tailor the intervention based on the Information-Motivation-Behavioral Skills Model of Adherence. The clinical-efficacy phase consisted of a pilot randomized controlled trial to evaluate the tailored eHealth intervention versus an AC. The tablet-delivered intervention included three parts: (1) a tailoring survey; (2) an individualized adherence profile; and (3) a personalized list of interactive adherence-promoting modules. The AC included the tailoring survey and health education videos delivered on the tablet. Feasibility was assessed as the number of patients who were retained in the study once they are consented and enrolled at baseline. Acceptability was assessed through semi-structured exit interviews. Medication adherence was assessed with the 8-item Morisky Medication Adherence Scale while BP and HbA1c were assessed using automated devices.

Results:

In Phase 1, thematic analysis of the semi-structured interviews revealed fiver major barriers to adherence: (1) disruptions in daily routine; (2) forgetfulness; (3) concerns about adverse effects; (4) preference for natural remedies; and (5) burdens of medication-taking. Patients recommended the inclusion of modules that address improving patient-provider communication, peer vignettes, and stress reduction strategies to facilitate adherence. A total of 42 Black patients (54.8% male; mean age: 57.6 years) participated in the clinical-efficacy pilot trial. One participant was lost to follow-up. At 3 months, both groups showed significant improvements in adherence (1.35, p<0.001) and SBP (-4.76mmHg, p=0.04) with no between-group differences (ps>0.05). The decreases in HbA1c and DBP overtime were non-significant (-1.97mmHg, p=0.20 and -0.2%, p=0.45, respectively). Patients reported high acceptability of the intervention for improving their adherence.

Conclusions:

This pilot study demonstrated preliminary evidence on the feasibility and acceptability of a tailored eHealth adherence intervention among a sample of Black patients with uncontrolled HTN and T2D, who were initially non-adherent to their medications. Future research should explore whether repeated opportunities to use the eHealth intervention would result in improvements in behavioral and clinical outcomes overtime. Modifications to the intervention as a result of the pilot study should also guide future efforts. Clinical Trial: clinicaltrials.gov NCT01643473