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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
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medication Adherence focused on measuring medication adherence, mHealth, China, heart disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 3, 2016
    Last Updated
    January 27, 2017
    Sponsor
    Duke University
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    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

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    A Mobile Phone Based Medication Reminder Program

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