NCT04703439

Brief Summary

Investigators evaluated the efficacy of a pilot-tested mHealth intervention to improving medication adherence and health outcomes among patients with coronary heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 20, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
Last Updated

April 27, 2023

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

January 7, 2021

Last Update Submit

April 25, 2023

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (4)

  • Change of medication non-adherence

    Participants' medication non-adherence scores were measured using the Voils Medication Non-Adherence Extent Scale. Specifically, participants received the question items of the Voils Medication Non-Adherence Extent Scale every 15 days on WeChat app and provided answers

    Participants' medication non-adherence scores were measured at enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)

  • Change of systolic blood pressure

    Participants self-measured their systolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators

    At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)

  • Change of diastolic blood pressure

    Participants self-measured their diastolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators

    At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)

  • Change of heart rate

    Participants self-measured their heart rates every 15 days using a blood pressure cuff and reported them to investigators

    At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)

Study Arms (2)

Experimental group

EXPERIMENTAL

This group consisted of 116 participants who received a medication-taking reminder every morning at a random time between 7-8 am on WeChat app. Also, participants received a piece of educational material every five days at a random time between 8 am and 9 am regarding improving medication adherence and preventing coronary heart disease.

Behavioral: Medication-taking reminders & educational materials

Control group

PLACEBO COMPARATOR

This group consisted of 114 participants who only received a piece of educational material every five days at a random time between 8 am and 9 am. The educational materials sent to this group were general medical information, which were not specifically about improving medication adherence or preventing coronary heart disease.

Behavioral: Educational materials

Interventions

Medication-taking reminders & educational materialsBEHAVIORAL

The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.

Experimental group
Educational materialsBEHAVIORAL

The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.

Control group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) had a medical diagnosis of coronary heart disease;
  • (2) aged 18 years or older;
  • (3) had an antihypertensive medication regimen for 90 days or more from enrollment;
  • (4) able to read messages through mobile phone;
  • (5) had a mobile phone that could receive messages from WeChat and reminders from Message Express;
  • (6) capable of giving his/her own consent; and
  • (7) had an electronic blood pressure cuff to check blood pressures and heart rates.

You may not qualify if:

  • was enrolled in other research studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

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.

    PMID: 35262490DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Prof. Ryan Shaw, PhD

    Duke University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

May 20, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 27, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)