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Completed

NCT Number: NCT04703439

An mHealth Intervention to Improve Medication Adherence and Health Outcomes

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

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

  • was enrolled in other research studies

Treatment and study plan

Medication-taking reminders & educational materials

Behavioral

The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.

Educational materials

Behavioral

The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.

Primary outcomes

  1. Change of medication non-adherence

    Time frame: 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

  2. Change of systolic blood pressure

    Time frame: 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

  3. Change of diastolic blood pressure

    Time frame: 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

  4. Change of heart rate

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • West China Hospital

Registry information

Official study title

A Mobile Phone Based Medication Reminder Program for Patients With Coronary Heart Diseases: A Pilot Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 11, 2021
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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