A Mobile Phone Based Medication Reminder Program

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Other: Daily reminders of taking medications; Other: Educational materials

• Registration Number: NCT02793830
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2016-06-03
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-08
• Study Start: 2016-07-11
• Primary Completion: 2016-09-19
• Study Completion: 2016-11-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile App Group	Daily reminders of taking medications	Participants in the experimental group will receive daily reminders and educational materials from mobile applications.
Mobile App Group	Educational materials	Participants in the experimental group will receive daily reminders and educational materials from mobile applications.
Control Group	Educational materials	The control group will receive the same educational materials, but no daily reminder.

Primary Outcome Measures

Name	Time	Method
Change in medication adherence score	baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.	Percent of prescribed antihypertensive drugs taken during the past three days.
Change in systolic blood pressure (SBP)	baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Change in diastolic blood pressure (DBP)	baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.

Secondary Outcome Measures

Name	Time	Method
Feasibility as measured by patient enrollment	approximately seven weeks	Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study).
Feasibility as measured by patient retention	approximately seven weeks	Feasibility will be determined by retention (percent of patients who complete the study)
Acceptability as measured by patient interviews	approximately seven weeks	Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.