A Mobile Phone Based Medication Reminder Program

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793830
• Other study ID #: Pro00073395
• Status: Completed
• Phase: N/A
• First received: June 3, 2016
• Last updated: January 27, 2017
• Start date: July 11, 2016
• Est. completion date: November 12, 2016

Study information

• Verified date: January 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 12, 2016
• Est. primary completion date: September 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Other:
• Daily reminders of taking medications
Reminders. Participants will receive medication-taking reminders from the researcher. These reminders are sent through the mobile application—BB Reminder on an unencrypted external device (a phone borrowed from Duke University School of Nursing and is used specifically for this study by the researcher). BB Reminder has the function that after inputting a patient's phone number and prescriptions, participants can receive reminders through text messages of the name, dosage, function, and administration route for every dose of his/her medications. The daily reminders will be sent to participants 15 minutes before every dose of their medications.
• Educational materials
Educational materials. Participants will receive educational materials from the researcher. These educational materials will be sent through the mobile application-WeChat. The educational materials include short articles (< 500 words) and/or pictures. They will be retrieved from the Chinese Cardiovascular Disease-Prevention Information Website (www.healthyheart-china.com), which is governed by the Chinese Ministry of Health. The validity of information from it is guaranteed. The retrieved educational materials will be screened by the cardiologist, the head nurse, and the researcher, before sending to participants. The educational materials will be sent to participants every other day at any time during 8 am and 10 pm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in medication adherence score	Percent of prescribed antihypertensive drugs taken during the past three days.	baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Primary	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.
Primary	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	Feasibility as measured by patient enrollment	Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study).	approximately seven weeks
Secondary	Feasibility as measured by patient retention	Feasibility will be determined by retention (percent of patients who complete the study)	approximately seven weeks
Secondary	Acceptability as measured by patient interviews	Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.	approximately seven weeks