An mHealth Intervention to Improve Medication Adherence and Health Outcomes

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Behavioral: Medication-taking reminders & educational materials
* Behavioral: Educational materials


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Behavioral: Medication-taking reminders & educational materials<br>* The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.<br>|
| Placebo Comparator: Control group<br>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. | Behavioral: Educational materials<br>* The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) |