Clinical trial NCT04703439: An mHealth Intervention to Improve Medication Adherence and Health Outcomes
Official title: A Mobile Phone Based Medication Reminder Program for Patients With Coronary Heart Diseases: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2021-01-11
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of medication non-adherence
timeFrame: 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)
measure: Change of systolic blood pressure
timeFrame: At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)
measure: Change of diastolic blood pressure
timeFrame: At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)
measure: Change of heart rate
timeFrame: At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Duke University
name: Prof. Ryan Shaw, PhD
role: STUDY_CHAIR
References:
citation: Ni Z, Wu B, Yang Q, Yan LL, Liu C, Shaw RJ. An mHealth Intervention to Improve Medication Adherence and Health Outcomes Among Patients With Coronary Heart Disease: Randomized Controlled Trial. J Med Internet Res. 2022 Mar 9;24(3):e27202. doi: 10.2196/27202.