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CompletedNCT04703439Updated Apr 27, 2023

An mHealth Intervention to Improve Medication Adherence and Health Outcomes

An interventional study of Medication-taking reminders & educational materials and Educational materials in Coronary Heart Disease, sponsored by Duke University. Completed at 1 site in China. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Duke University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled May 2018, registered Jan 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
230
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 230 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • was enrolled in other research studies
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
230 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Medication-taking reminders & educational materials

  • Placebo comparator
    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.

    Behavioral: Educational materials

Interventions

  • BehavioralMedication-taking reminders & educational materials

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

  • BehavioralEducational materials

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

06

What researchers measure

Primary outcomes

  1. 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

    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)

  2. 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

    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)

  3. 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

    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)

  4. Change of heart rate

    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)

07

Study locations

1 site
  • West China Hospital
    Chengdu, Sichuan 610041, China
08

References and documents

Publications

  • 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. PubMed 35262490 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04703439
Lead sponsor
Duke University
Collaborators
West China Hospital
Responsible party
Sponsor
First posted
Jan 11, 2021
Start date
May 20, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Apr 27, 2023

Study contacts

Prof. Ryan Shaw, PhD
study chair · Duke University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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