An mHealth Intervention to Improve Medication Adherence and Health Outcomes

Not Applicable

Completed

• Conditions: Coronary Heart Disease
• Interventions: Behavioral: Medication-taking reminders & educational materials; Behavioral: Educational materials

• Registration Number: NCT04703439
• Lead Sponsor: Duke University

Brief Summary

Investigators evaluated the efficacy of a pilot-tested mHealth intervention to improving medication adherence and health outcomes among patients with coronary heart disease.

Detailed Description

This was a two-arm parallel randomized controlled trial, in which 116 and 114 participants were assigned to the experimental and control groups, respectively. The mHealth intervention in this study had been pilot tested and tailored. Specifically, the experimental group received a medication-taking reminder every morning via WeChat app and educational materials of coronary heart disease and medication adherence every five days via Message Express app. The control group received only general educational materials, which were irrelevant to coronary heart disease or medication adherence, every 5 days via Message Express app. All participants were diagnosed with coronary heart disease. The specific recruitment criteria of participants had been published in peer-reviewed journal.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-20
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2021-01
• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• (1) had a medical diagnosis of coronary heart disease;
• (2) aged 18 years or older;
• (3) had an antihypertensive medication regimen for 90 days or more from enrollment;
• (4) able to read messages through mobile phone;
• (5) had a mobile phone that could receive messages from WeChat and reminders from Message Express;
• (6) capable of giving his/her own consent; and
• (7) had an electronic blood pressure cuff to check blood pressures and heart rates.

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Exclusion Criteria

• was enrolled in other research studies

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Medication-taking reminders & educational materials	This group consisted of 116 participants who received a medication-taking reminder every morning at a random time between 7-8 am on WeChat app. Also, participants received a piece of educational material every five days at a random time between 8 am and 9 am regarding improving medication adherence and preventing coronary heart disease.
Control group	Educational materials	This group consisted of 114 participants who only received a piece of educational material every five days at a random time between 8 am and 9 am. The educational materials sent to this group were general medical information, which were not specifically about improving medication adherence or preventing coronary heart disease.

Primary Outcome Measures

Name	Time	Method
Change of diastolic blood pressure	At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)	Participants self-measured their diastolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators
Change of heart rate	At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)	Participants self-measured their heart rates every 15 days using a blood pressure cuff and reported them to investigators
Change of medication non-adherence	Participants' medication non-adherence scores were measured at enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)	Participants' medication non-adherence scores were measured using the Voils Medication Non-Adherence Extent Scale. Specifically, participants received the question items of the Voils Medication Non-Adherence Extent Scale every 15 days on WeChat app and provided answers
Change of systolic blood pressure	At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)	Participants self-measured their systolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China