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An mHealth Intervention to Improve Medication Adherence and Health Outcomes

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Medication-taking reminders & educational materials
Educational materials
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Heart Disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • was enrolled in other research studies

Sites / Locations

  • West China Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 7, 2021
Last Updated
April 25, 2023
Sponsor
Duke University
Collaborators
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04703439
Brief Title
An mHealth Intervention to Improve Medication Adherence and Health Outcomes
Official Title
A Mobile Phone Based Medication Reminder Program for Patients With Coronary Heart Diseases: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This was a two-arm parallel randomized controlled trial, in which 116 and 114 participants were assigned to the experimental and control groups, respectively. The mHealth intervention in this study had been pilot tested and tailored. Specifically, the experimental group received a medication-taking reminder every morning via WeChat app and educational materials of coronary heart disease and medication adherence every five days via Message Express app. The control group received only general educational materials, which were irrelevant to coronary heart disease or medication adherence, every 5 days via Message Express app. All participants were diagnosed with coronary heart disease. The specific recruitment criteria of participants had been published in peer-reviewed journal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medication-taking reminders & educational materials
Intervention Description
The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.
Intervention Type
Behavioral
Intervention Name(s)
Educational materials
Intervention Description
The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.
Primary Outcome Measure Information:
Title
Change of medication non-adherence
Description
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
Time Frame
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)
Title
Change of systolic blood pressure
Description
Participants self-measured their systolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators
Time Frame
At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)
Title
Change of diastolic blood pressure
Description
Participants self-measured their diastolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators
Time Frame
At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)
Title
Change of heart rate
Description
Participants self-measured their heart rates every 15 days using a blood pressure cuff and reported them to investigators
Time Frame
At enrollment (baseline), 15-day, 30-day, 45-day, 60-day (end of intervention), 75-day, and 90-day (end of follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: was enrolled in other research studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Ryan Shaw, PhD
Organizational Affiliation
Duke University
Official's Role
Study Chair
Facility Information:
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

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

Learn more about this trial

An mHealth Intervention to Improve Medication Adherence and Health Outcomes

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