Abstract

BackgroundResearch has underscored the need to develop socioculturally tailored interventions to improve adherence behaviors in minority patients with hypertension (HTN) and type 2 diabetes (T2D). Novel mobile health (mHealth) approaches are potential methods for delivering tailored interventions to minority patients with increased cardiovascular risk.ObjectiveThis study aims to develop and evaluate the acceptability and preliminary efficacy of a tailored mHealth adherence intervention versus attention control (AC) on medication adherence, systolic blood pressure (SBP), diastolic blood pressure (DBP), and hemoglobin A1c (HbA1c) at 3 months in 42 Black patients with uncontrolled HTN and/or T2D who were initially nonadherent to their medications.MethodsThis 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 (7/10, 70% female; mean age 65.8 years, SD 5.6) to tailor the intervention based on the Information-Motivation-Behavioral skills model of adherence. The clinical efficacy phase consisted of a 3-month pilot randomized controlled trial to evaluate the tailored mHealth intervention versus an AC. The tablet-delivered intervention included a tailoring survey, an individualized adherence profile, and a personalized list of interactive adherence-promoting modules, whereas AC included the tailoring survey and health education videos delivered on the tablet. Acceptability was assessed through semistructured exit interviews. Medication adherence was assessed using the 8-item Morisky Medication Adherence Scale, whereas blood pressure and HbA1c were assessed using automated devices.ResultsIn phase 1, thematic analysis of the semistructured interviews revealed the following 5 major barriers to adherence: disruptions in daily routine, forgetfulness, concerns about adverse effects, preference for natural remedies, and 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 (23/42, 55% male; mean age 57.6 years, SD 11.1) participated in the clinical efficacy pilot trial. At 3 months, both groups showed significant improvements in adherence (mean 1.35, SD 1.60; P<.001) and SBP (−4.76 mm Hg; P=.04) with no between-group differences (P=.50 and P=.10). The decreases in DBP and HbA1c over time were nonsignificant (−1.97 mm Hg; P=.20; and −0.2%; P=.45, respectively). Patients reported high acceptability of the intervention for improving their adherence.ConclusionsThis pilot study demonstrated preliminary evidence on the acceptability of a tailored mHealth adherence intervention among a sample of Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications. Future research should explore whether repeated opportunities to use the mHealth intervention would result in improvements in behavioral and clinical outcomes over time. Modifications to the intervention as a result of the pilot study should guide future efforts.Trial RegistrationClinicalTrials.gov NCT01643473; http://clinicaltrials.gov/ct2/show/ NCT01643473

Highlights

  • BackgroundDespite advances in treatments for hypertension (HTN) and type 2 diabetes (T2D), Black patients continue to experience disproportionately lower rates of blood pressure (BP) and glycemic control than those observed in White patients [1,2]

  • Patients reported high acceptability of the intervention for improving their adherence. This pilot study demonstrated preliminary evidence on the acceptability of a tailored mobile health (mHealth) adherence intervention among a sample of Black patients with uncontrolled HTN and T2D who were initially nonadherent to their medications

  • Future research should explore whether repeated opportunities to use the mHealth intervention would result in improvements in behavioral and clinical outcomes over time

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Summary

Introduction

BackgroundDespite advances in treatments for hypertension (HTN) and type 2 diabetes (T2D), Black patients continue to experience disproportionately lower rates of blood pressure (BP) and glycemic control than those observed in White patients [1,2]. Poor medication adherence among Black patients may explain the disproportionately lower rates of BP and glucose control in this patient population than in White patients [3,4]. Of the mHealth interventions that have aimed to improve medication adherence, only 6 have been conducted in high-risk minority populations with HTN or T2D, all of which used text messages as their primary method of intervention delivery [11,12,13,14,15,16]. Reading and responding to text messages require a level of visual acuity and dexterity that may be challenging for people who experience any motor and/or visual impairments This is especially true for patients with uncontrolled T2D and/or HTN who may experience retinopathy as a result of their disease. Novel mobile health (mHealth) approaches are potential methods for delivering tailored interventions to minority patients with increased cardiovascular risk

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