A Mobile Phone Based Medication Reminder Program
Primary Purpose
Medication Adherence
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Daily reminders of taking medications
Educational materials
Sponsored by

About this trial
This is an interventional prevention trial for Medication Adherence focused on measuring medication adherence, mHealth, China, heart disease
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile App Group
Control Group
Arm Description
Participants in the experimental group will receive daily reminders and educational materials from mobile applications.
The control group will receive the same educational materials, but no daily reminder.
Outcomes
Primary Outcome Measures
Change in medication adherence score
Percent of prescribed antihypertensive drugs taken during the past three days.
Change in systolic blood pressure (SBP)
Change in diastolic blood pressure (DBP)
Secondary Outcome Measures
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).
Feasibility as measured by patient retention
Feasibility will be determined by retention (percent of patients who complete the study)
Acceptability as measured by patient interviews
Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02793830
Brief Title
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
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 11, 2016 (undefined)
Primary Completion Date
September 19, 2016 (Actual)
Study Completion Date
November 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Adherence
Keywords
medication adherence, mHealth, China, heart disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile App Group
Arm Type
Experimental
Arm Description
Participants in the experimental group will receive daily reminders and educational materials from mobile applications.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive the same educational materials, but no daily reminder.
Intervention Type
Other
Intervention Name(s)
Daily reminders of taking medications
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Educational materials
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in medication adherence score
Description
Percent of prescribed antihypertensive drugs taken during the past three days.
Time Frame
baseline, day 3, day 6, day 9, day 12, day 15, day 18, day 21, day 24, day 27, day 30.
Title
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.
Title
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 Outcome Measure Information:
Title
Feasibility as measured by patient enrollment
Description
Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study).
Time Frame
approximately seven weeks
Title
Feasibility as measured by patient retention
Description
Feasibility will be determined by retention (percent of patients who complete the study)
Time Frame
approximately seven weeks
Title
Acceptability as measured by patient interviews
Description
Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.
Time Frame
approximately seven weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35262490
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.
Results Reference
derived
Learn more about this trial
A Mobile Phone Based Medication Reminder Program
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