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An mHealth Intervention to Improve Medication Adherence and Health Outcomes

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ClinicalTrials.gov Identifier: NCT04703439
Recruitment Status : Completed
First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Duke University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Behavioral: Medication-taking reminders & educational materials Behavioral: Educational materials Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Mobile Phone Based Medication Reminder Program for Patients With Coronary Heart Diseases: A Pilot Study
Actual Study Start Date : May 20, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.
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
The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.


Outcome Measures
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Primary Outcome Measures :
  1. Change of medication non-adherence [ 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) ]
    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

  2. Change of systolic blood pressure [ 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) ]
    Participants self-measured their systolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators

  3. Change of diastolic blood pressure [ 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) ]
    Participants self-measured their diastolic blood pressures every 15 days using a blood pressure cuff and reported them to investigators

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04703439


Locations
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China, Sichuan
West China Hospital
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Duke University
West China Hospital
Investigators
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Study Chair: Prof. Ryan Shaw, PhD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04703439    
Other Study ID Numbers: Pro00073395_1
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases