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Clinical Trials/NCT02793830
NCT02793830
Completed
Not Applicable

A Mobile Phone Based Medication Reminder Program for Patients in China With Coronary Heart Disease: A Pilot Study

Duke University0 sites49 target enrollmentJuly 11, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medication Adherence
Sponsor
Duke University
Enrollment
49
Primary Endpoint
Change in medication adherence score
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 11, 2016
End Date
November 12, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in medication adherence score

Time Frame: 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)

Time Frame: 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)

Time Frame: baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.

Secondary Outcomes

  • Feasibility as measured by patient enrollment(approximately seven weeks)
  • Feasibility as measured by patient retention(approximately seven weeks)
  • Acceptability as measured by patient interviews(approximately seven weeks)

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