NCT02793830

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

July 11, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2016

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

2 months

First QC Date

June 3, 2016

Last Update Submit

January 27, 2017

Conditions

Keywords

medication adherencemHealthChinaheart disease

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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 Outcomes (3)

  • Feasibility as measured by patient enrollment

    approximately seven weeks

  • Feasibility as measured by patient retention

    approximately seven weeks

  • Acceptability as measured by patient interviews

    approximately seven weeks

Study Arms (2)

Mobile App Group

EXPERIMENTAL

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

Other: Daily reminders of taking medicationsOther: Educational materials

Control Group

ACTIVE COMPARATOR

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

Other: Educational materials

Interventions

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.

Mobile App Group

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 GroupMobile App Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Medication AdherenceHeart Diseases

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 8, 2016

Study Start

July 11, 2016

Primary Completion

September 19, 2016

Study Completion

November 12, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share