A Mobile Phone Based Medication Reminder Program

NCT ID: NCT02793830

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-11
• Study Completion Date: 2016-11-12

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.

Conditions

Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mobile App Group

Participants in the experimental group will receive daily reminders and educational materials from mobile applications.

Group Type: EXPERIMENTAL

Daily reminders of taking medications

Intervention Type: OTHER

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

Intervention Type: OTHER

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.

Control Group

The control group will receive the same educational materials, but no daily reminder.

Group Type: ACTIVE_COMPARATOR

Educational materials

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 35262490 (View on PubMed)

Other Identifiers

Pro00073395

Identifier Type: -

Identifier Source: org_study_id