Status:
COMPLETED
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
Lead Sponsor:
Abbott
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-75 years
Brief Summary
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 dyslipidemi...
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 define...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18-75 years (inclusive)
- Subjects who have provided written informed consent
- 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
- Subjects who were on a stable lipid-lowering therapy within 1 month prior to the screening visit
- 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
- Subjects for whom lipid profile laboratory data is available from routine care within 14 days prior to the screening visit
- 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
- 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.
- Able to read and understand Thai
- Willing and able to comply with the study requirements.
Exclusion
- 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
- 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
- Subjects receiving injectable lipid-lowering therapy
- Subjects who are currently using other medication-use-related mobile applications.
Key Trial Info
Start Date :
April 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05370703
Start Date
April 26 2022
End Date
November 18 2022
Last Update
February 15 2023
Active Locations (1)
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1
Chatlert Mueang Pongchaiyakul
Khon Kaen, Thailand, 40002