Clinical trial NCT05370703: 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
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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 dyslipidemia in Thailand

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks (± 7 days)
Secondary outcomes:
measure: 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
timeFrame: 12 weeks (± 7 days)
measure: 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
timeFrame: 12 weeks (± 7 days)
measure: 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
timeFrame: 12 weeks (± 7 days)
Other outcomes:
measure: Correlations between subjects' adherence to lipid-lowering therapy and mobile applications data using individual summaries retrieved from the application database.
timeFrame: 12 weeks (± 7 days)
Locations:
city: Khon Kaen
country: Thailand
facility: Chatlert Mueang Pongchaiyakul
Study officials:
affiliation: Abbott
name: Jean-Pascal Berrou, MD, Phd
role: STUDY_DIRECTOR
References: