An observational study in Dyslipidemia, sponsored by Abbott. Completed at 1 site in Thailand. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-15.
Sponsored by Abbott · Observational
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
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.
1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.
This study's enrollment of 150 is below the median of 648 across 229 observational studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.
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This is a prospective, randomized, open-label, clinical study in subjects with dyslipidemia and suboptimal adherence to their current lipid-lowering therapy in Thailand.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will continue their current lipid-lowering therapy and will not need to download any mobile application.
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
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
Mobile application with Motivational messages
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
Adherence is measured by change from Baseline in MARS-5VA Scores at 12 Weeks
Time frame: 12 weeks (± 7 days)
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
Level of lipid control is measured by change from Baseline in the subject's lipid profile at 12 weeks
Time frame: 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
Subjects' perception to medications in general measured by change from Baseline in BMQ-General-12 and PSM-5 Questionnaires at 12 weeks
Time frame: 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
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
Time frame: 12 weeks (± 7 days)
Correlations between subjects' adherence to lipid-lowering therapy and mobile applications data using individual summaries retrieved from the application database.
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
Time frame: 12 weeks (± 7 days)
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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