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Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial

BACKGROUND: Research 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...

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Autores principales: Schoenthaler, Antoinette, Leon, Michelle, Butler, Mark, Steinhaeuser, Karsten, Wardzinski, William
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542413/
https://www.ncbi.nlm.nih.gov/pubmed/32965230
http://dx.doi.org/10.2196/17135
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author Schoenthaler, Antoinette
Leon, Michelle
Butler, Mark
Steinhaeuser, Karsten
Wardzinski, William
author_facet Schoenthaler, Antoinette
Leon, Michelle
Butler, Mark
Steinhaeuser, Karsten
Wardzinski, William
author_sort Schoenthaler, Antoinette
collection PubMed
description BACKGROUND: Research 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. OBJECTIVE: This 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 A(1c) (HbA(1c)) at 3 months in 42 Black patients with uncontrolled HTN and/or T2D who were initially nonadherent 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 (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 HbA(1c) were assessed using automated devices. RESULTS: In 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 HbA(1c) 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. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT01643473; http://clinicaltrials.gov/ct2/show/ NCT01643473
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spelling pubmed-75424132020-10-20 Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial Schoenthaler, Antoinette Leon, Michelle Butler, Mark Steinhaeuser, Karsten Wardzinski, William JMIR Mhealth Uhealth Original Paper BACKGROUND: Research 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. OBJECTIVE: This 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 A(1c) (HbA(1c)) at 3 months in 42 Black patients with uncontrolled HTN and/or T2D who were initially nonadherent 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 (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 HbA(1c) were assessed using automated devices. RESULTS: In 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 HbA(1c) 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. CONCLUSIONS: This 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 REGISTRATION: ClinicalTrials.gov NCT01643473; http://clinicaltrials.gov/ct2/show/ NCT01643473 JMIR Publications 2020-09-23 /pmc/articles/PMC7542413/ /pubmed/32965230 http://dx.doi.org/10.2196/17135 Text en ©Antoinette Schoenthaler, Michelle Leon, Mark Butler, Karsten Steinhaeuser, William Wardzinski. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 23.09.2020. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.
spellingShingle Original Paper
Schoenthaler, Antoinette
Leon, Michelle
Butler, Mark
Steinhaeuser, Karsten
Wardzinski, William
Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial
title Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial
title_full Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial
title_fullStr Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial
title_full_unstemmed Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial
title_short Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial
title_sort development and evaluation of a tailored mobile health intervention to improve medication adherence in black patients with uncontrolled hypertension and type 2 diabetes: pilot randomized feasibility trial
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542413/
https://www.ncbi.nlm.nih.gov/pubmed/32965230
http://dx.doi.org/10.2196/17135
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