An mHealth Intervention to Improve Medication Adherence and Health Outcomes

NCT ID: NCT04703439

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-20

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

Medication-taking reminders & educational materials

Intervention Type BEHAVIORAL

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

Control group

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.

Group Type PLACEBO_COMPARATOR

Educational materials

Intervention Type BEHAVIORAL

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

Interventions

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Medication-taking reminders & educational materials

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

Intervention Type BEHAVIORAL

Educational materials

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Ryan Shaw, PhD

Role: STUDY_CHAIR

Duke University

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35262490 (View on PubMed)

Other Identifiers

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Pro00073395_1

Identifier Type: -

Identifier Source: org_study_id

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