A Clinical Study to Evaluate the Effect of Mobile Applications "My A:Care" and "Smart Coach" on the Lipid-lowering Treatment Adherence of Subjects With Dyslipidemia in Thailand (My A:Care)

February 14, 2023 updated by: Abbott

A Prospective, Randomized, Open-label, Clinical Study to Evaluate the Effect of Mobile Applications "My A:Care" and "Smart Coach" on the Lipid-lowering Treatment Adherence of Subjects With Dyslipidemia in Thailand

A prospective, randomized, open-label, clinical study to evaluate the effect of mobile applications "My A:Care" and "Smart Coach" on the lipid-lowering treatment adherence of subjects with dyslipidemia in Thailand

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, randomized, open-label, clinical study in subjects with dyslipidemia and suboptimal adherence to their current lipid-lowering therapy in Thailand. Suboptimal adherence is defined as having <22 points score on the Part 1 of MARS-5VA questionnaire. This questionnaire comprises 2 parts, Medication Adherence Report Scale (MARS-5) as Part 1 and two Visual Analogue Scales (VAS) as Part 2. The complete MARS-5VA questionnaire (Part 1 and 2) will be used to evaluate subject adherence to lipid-lowering therapy in the study. The Part 1 of MARS-5VA will also be used to confirm subject's eligibility at screening. Subjects who are continuing the stable lipid-lowering therapy for at least 1 month are being considered for this study. Subjects will be randomized to different types of behavior interventions using mobile applications that will be used in addition to their current standard of care (SOC) lipid-lowering therapy.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Chatlert Mueang Pongchaiyakul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This is a prospective, randomized, open-label, clinical study in subjects with dyslipidemia and suboptimal adherence to their current lipid-lowering therapy in Thailand.

Description

Inclusion Criteria:

  1. Male and female subjects aged 18-75 years (inclusive)
  2. Subjects who have provided written informed consent
  3. Subjects who were diagnosed with dyslipidemia and initiated lipid-lowering therapy based on local treatment guidelines, between 9 months and 1 month prior to the screening visit
  4. Subjects who were on a stable lipid-lowering therapy within 1 month prior to the screening visit
  5. Subjects who are not compliant with the prescribed lipid-lowering therapy, assessed as having <22 points score on the Part 1 of MARS-5VA questionnaire at the screening visit
  6. Subjects for whom lipid profile laboratory data is available from routine care within 14 days prior to the screening visit
  7. Subject must have their own Android operating system smart phone and a data package suitable for the installation and running of the mobile application and sending and receiving data
  8. Willing and able to operate the mobile devices, including use of all study-related smartphone applications; able to proof regular use of mobile applications in their daily life.
  9. Able to read and understand Thai
  10. Willing and able to comply with the study requirements.

Exclusion Criteria:

  1. Subjects who are diagnosed with myocardial infarction or stroke or unstable angina within 2 months prior to screening, subjects who are hospitalized for their cardio-vascular condition and requiring changes in administration of their lipid-lowering medication
  2. Subjects who experienced undesirable effects of their lipid-lowering medication and who might, in the opinion of the investigator, require its modification or discontinuation during the 12 weeks of observation period of the study
  3. Subjects receiving injectable lipid-lowering therapy
  4. Subjects who are currently using other medication-use-related mobile applications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of Care (SOC) group
This group will continue their current lipid-lowering therapy and will not need to download any mobile application.
SOC + My A:Care group:
This group will continue their current lipid-lowering therapy along with access to the mobile application My A:Care that supports medication adherence through motivational messages and challenges, health insights, and medication reminders.
Behavioral: My A:care
Mobile application with Motivational messages
SOC + Smart Coach group:

This group will continue their current lipid-lowering therapy along with access to the mobile application Smart Coach that supports medication adherence through personalized motivational messages and challenges, health insights, and medication reminders. Personalization of the messages and challenges will be based on a behavioral profiling Social, Psychological, Usage, Rational (SPUR™) questionnaire that is completed at randomization to the Smart Coach application.

Study site will guide the subjects on how to use these mobile applications. Eligibility assessment will be based on information collected at screening/baseline visit (Visit 1) and assessment of Part 1 of MARS 5VA questionnaire. Adherence at baseline (Visit 1) and after 12 weeks of observation (Visit 2), will be evaluated by the complete MARS 5VA (Part 1 and 2) questionnaire. Each subject will be followed up for approximately 12 weeks from randomization at Visit 1.
Behavioral: Smart Coach
Mobile application with Motivational messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of mobile applications (My A:Care and Smart Coach) on adherence to the lipid-lowering therapy in subjects with dyslipidemia using MARS-5VA questionnaire
Time Frame: 12 weeks (± 7 days)
Adherence is measured by change from Baseline in MARS-5VA Scores at 12 Weeks
12 weeks (± 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of mobile applications (My A:Care and Smart Coach) on level of lipid control in subjects with dyslipidemia by measuring the subject's lipid profile
Time Frame: 12 weeks (± 7 days)
Level of lipid control is measured by change from Baseline in the subject's lipid profile at 12 weeks
12 weeks (± 7 days)
Impact of mobile applications (My A:Care and Smart Coach) on the subjects' perception to medications in general using BMQ-General-12 and PSM-5 Questionnaires
Time Frame: 12 weeks (± 7 days)
Subjects' perception to medications in general measured by change from Baseline in BMQ-General-12 and PSM-5 Questionnaires at 12 weeks
12 weeks (± 7 days)
Impact of mobile applications (My A:Care and Smart Coach) on the subjects' perception to medications specific to lipid-lowering therapy using BMQ-S11-Plural and MAIN Screen Questionnaires
Time Frame: 12 weeks (± 7 days)
Subjects' perception to medications specific to lipid-lowering therapy measured by change from Baseline in BMQ-S11-Plural and MAIN Screen Questionnaires at 12 weeks
12 weeks (± 7 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between subjects' adherence to lipid-lowering therapy and mobile applications data using individual summaries retrieved from the application database.
Time Frame: 12 weeks (± 7 days)
Correlations between subjects' adherence to lipid-lowering therapy and mobile applications data is measured by using individual summaries retrieved from the application database at 12 week
12 weeks (± 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2022

Primary Completion (Actual)

August 18, 2022

Study Completion (Actual)

November 18, 2022

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPID-I21-0159

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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