Clinical trial NCT02793830: A Mobile Phone Based Medication Reminder Program
Official title: A Mobile Phone Based Medication Reminder Program for Patients in China With Coronary Heart Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: medication adherence
mHealth
China
heart disease
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the feasibility and acceptability of using mobile applications to improve medication adherence. Participants in the experimental group will receive educational materials and daily reminders through mobile applications. While, participants in the control group will receive only educational materials. After the intervention, interviews will be conducted among participants through phone calls.

Detailed description: The purpose of this study is to improve medication adherence for Chinese patients with coronary heart disease (CHD) by using mobile applications. An exploratory randomized controlled trial (RCT, N=49) and interviews (n=15) will be included in this pilot study. The RCT will compare the effects of the medication adherence (MA, n=24) intervention and control condition (n=25) on the MA score (percent of prescribed antihypertensive drugs taken), and health outcomes (SBP and DBP obtained) of patients. The health outcomes will be assessed at enrollment and every three days after the intervention begins for thirty days. Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study). Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through focus group interviews. All analyses will be performed using SAS 9.3 (Cary, NC). The potential risks of this study are minimal.

Eligibility criteria: Inclusion criteria for participants are:

* having a medical diagnosis of CHD
* being eighteen years old or older
* having an antihypertensive medication regimen that lasts for forty-nine days or more at the enrollment
* being able to read messages through mobile phone
* having a mobile phone which can receive messages from WeChat, and can receive daily reminders from BB Reminder
* having no obvious cognitive impairment
* patients with comorbidities can be included in the study, but during the study, antihypertensive medications are their only prescribed medications (this will be screened by the cardiologist).

Primary outcomes:
measure: Change in medication adherence score
timeFrame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
measure: Change in systolic blood pressure (SBP)
timeFrame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
measure: Change in diastolic blood pressure (DBP)
timeFrame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Secondary outcomes:
measure: Feasibility as measured by patient enrollment
timeFrame: approximately seven weeks
measure: Feasibility as measured by patient retention
timeFrame: approximately seven weeks
measure: Acceptability as measured by patient interviews
timeFrame: approximately seven weeks
Other outcomes:
Locations:
Study officials:
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.