DyslipidemiaMy A:CareNCT05370703
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
An observational study of Dyslipidemia, run by Abbott at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- My A:care and Smart Coach
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 26 Apr 2022to 18 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Dyslipidemia
- Being tested
- My A:care, Smart Coach
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My A:careBehavioural
Mobile application with Motivational messages
Smart CoachBehavioural
Mobile application with Motivational messages
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: My A:care | |
| 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. Receives: Behavioral: Smart Coach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks (± 7 days)
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 12 weeks (± 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start26 Apr 2022
- Primary completion18 Aug 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pascal Berrou, MD, Phd, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370703
- Sponsor's protocol ID
- EPID-I21-0159
- Acronym
- My A:Care
- Status last verified
- Feb 2023
- First submitted
- 1 Apr 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pongchaiyakul C, Driessen S. Evaluating the effect of mobile applications "My A:Care" and "Smart Coach" on adherence to lipid-lowering treatment in patients with dyslipidemia: a prospective, randomized, open-label clinical study. Front Digit Health. 2025 Jul 7;7:1502990. doi: 10.3389/fdgth.2025.1502990. eCollection 2025.
PubMed 40692655
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05370703
- Acronym / sponsor ID
- My A:Care / EPID-I21-0159
- Conditions
- Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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: | – | Behavioral: My A:careThis 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. |
| SOC + Smart Coach group: | – | Behavioral: Smart CoachThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My A:careMobile application with Motivational messages | Behavioural | SOC + My A:Care group: |
| Smart CoachMobile application with Motivational messages | Behavioural | SOC + Smart Coach group: |
Primary outcome
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
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 40692655Pongchaiyakul C, Driessen S. Evaluating the effect of mobile applications "My A:Care" and "Smart Coach" on adherence to lipid-lowering treatment in patients with dyslipidemia: a prospective, randomized, open-label clinical study. Front Digit Health. 2025 Jul 7;7:1502990. doi: 10.3389/fdgth.2025.1502990. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pascal Berrou, MD, Phd study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslipidemia, run by Abbott at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 weeks (± 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370703, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.