An mHealth Intervention to Improve Medication Adherence and Health Outcomes

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703439
• Other study ID #: Pro00073395_1
• Status: Completed
• Phase: N/A
• Start date: May 20, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Behavioral:
• Medication-taking reminders & educational materials
The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.
• Educational materials
The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of medication non-adherence	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	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)
Primary	Change of systolic blood pressure	Participants self-measured their systolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators	At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)
Primary	Change of diastolic blood pressure	Participants self-measured their diastolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators	At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)
Primary	Change of heart rate	Participants self-measured their heart rates every 15 days using a blood pressure cuff and reported them to investigators	At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)