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Completed

NCT Number: NCT02793830

A Mobile Phone Based Medication Reminder Program

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.

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Key information

Conditions

Medication Adherence Behavior Cardiovascular Diseases Health Behavior Heart Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Daily reminders of taking medications

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Feasibility as measured by patient enrollment

    Time frame: approximately seven weeks

    Feasibility will be determined by the number of patients enrolled, and retention (percent of patients who complete the study).

  2. Feasibility as measured by patient retention

    Time frame: approximately seven weeks

    Feasibility will be determined by retention (percent of patients who complete the study)

  3. Acceptability as measured by patient interviews

    Time frame: approximately seven weeks

    Acceptability (read daily reminders and educational materials via mobile applications) will be evaluated through interviews.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 8, 2016
Registry last updated
Jan 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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