HypertensionNCT06779591
Implementation and Effectiveness of "CareAide® App" for People with Cardiometabolic Diseases At a Primary Care Clinic
A study testing CareAide® Medication Adherence Mobile Application in people with Hypertension and Diabetes Mellitus Type 2, run by University of Malaya at 1 site in Malaysia.
Trial summary
This study aims to explore the barriers and facilitators to implement CareAide® app among healthcare providers and patients at a primary care clinic in Malaysia. This is an implementation-qualitative research study meaning researchers will collect data regarding the adoption rate, ease of implementation and adoption… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus Type 2, Dyslipidemia
- What is being tested?
- CareAide® Medication Adherence Mobile Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old
- Medically diagnosed with either hypertension, type 2 diabetes and dyslipidemia for at least 6 months as listed in electronic health records
- Exhibit a low adherence indicated by Malaysia Medication Adherence Assessment Tool (MyMAAT) scores of <54 scores
- Taking at least one type of medication daily, three medications daily or two medications with multiple dosing intervals prescribed,
- Owns and able to use a smartphone
- Able to read English or Malay
Who cannot join
- Individuals who are pregnant, already using any adherence apps or diagnosed with any terminal illnesses, visually impaired, disability or mental health related illnesses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Universiti Malaya Medical Centre
Petaling Jaya, Kuala Lumpur, 50603
Hooi Chin Beh, +6012 443 8038, hcbeh@ummc.edu.my
About this study
Official title: Implementation and Effectiveness of the Medication Adherence "CareAide® App" for People with Cardiometabolic Diseases At an Academic Primary Care Clinic in Malaysia: a Hybrid Implementation-effectiveness Study
This study aims to explore the barriers and facilitators to implement CareAide® app among healthcare providers and patients at a primary care clinic in Malaysia.
This is an implementation-qualitative research study meaning researchers will collect data regarding the adoption rate, ease of implementation and adoption, and patient's willingness to use the application. The researchers will also compare the effectiveness of the application as a tool to remind patients to take their medicine, by comparing between a group of participants who use the app and another group of participants who do not use the app.
This study requires participants to use an app, then attend some routine follow-ups and be administered blood tests, followed by an interview to collect their opinions, feelings, and experiences.
- Conditions
- Hypertension, Diabetes Mellitus Type 2, Dyslipidemia
- Being tested
- CareAide® Medication Adherence Mobile Application
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareAide® Medication Adherence Mobile ApplicationOther
CareAide® app is one of the mobile apps in assisting and improving patients' adherence to medications. It is an unique health-tech and insure-tech company with expertise in behavioural science, chronic condition management and technology. The app aims to help patients with chronic conditions live a better everyday life and empower their families and the ecosystem around the patients to drive better outcomes. They have the clinically validated approach to improving adherence. Using behavioural science and smart tech, they improve the day-to-day life of patients, and importantly, empower both patients and health care providers with the digital tools and near real-time insights to proactively manage risks, intervene early to avoid patient emergencies and to help to provide a better customer satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group participants will receive 24 weeks of free, unlimited access to the CareAide® app.
The CareAide® app will help the intervention group track their medication, view health statistics, help in remote management, act as a health diary, act as a virtual drug cabinet, access medical record files, educate patients and their families, and foster community among afflicted patients.
Participants will be assisted by the study coordinator to download the App onto their smartphones and how to navigate the app upon recruitment. They will be asked to use the app to manage their medications for a period of 24 weeks. Participants in the IG will participate in the use of the app for from 0 to 24 weeks while the control group will continue with their usual routine. Assessment of adherence levels and pertinent clinical outcomes is scheduled at the end of 24 weeks of the intervention following the enrolment of participants for both study groups. Receives: Other: CareAide® Medication Adherence Mobile Application |
| Control Group | No intervention | Participants in the control group will continue with their usual routine without being aware of the existence of the app. Assessment of adherence levels and pertinent clinical outcomes is scheduled at the end of 24 weeks of the intervention following the enrolment of participants for both study groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach
The absolute number, proportion, and representativeness of individuals who are willing to participate in a given initiative, intervention, or program.
A proxy for reach was used and defined as the percentage of patients who gave informed consent to participate out of all patients approached.
Measured: Before the start of intervention
Effectiveness
The impact of CareAide® app on medication adherence using the Malaysia Medication Adherence Assessment Tool (MyMAAT) score, with 12 points being the minimum score and 60 points being the maximum. Patients are classified as moderate \& poor adherence if their score is < 54. Patients have good adherence if their score is ≥ 54.
Measured: Before the start of the intervention, and at 24 weeks after the intervention
Effectiveness
The impact of CareAide® app on hypertension, measured by taking the patient's systolic and diastolic blood pressure in mmHg.
Measured: Before the start of the intervention, and at 24 weeks after the intervention
Effectiveness
The impact of CareAide® app on type 2 diabetes by measuring the patient's fasting blood glucose (mmol/L) and HbA1c (%).
Measured: Before the start of the intervention, and at 24 weeks after the intervention
Effectiveness
The impact of CareAide® app on dyslipidaemia outcomes, measured by taking the patient's total cholesterol (mmol/L), low-density lipoprotein (mmol/L), high density lipoprotein (mmol/L), and triglyceride level (mmol/L).
Measured: Before the start of the intervention, and at 24 weeks after the intervention
Adoption
The absolute number, proportion, and representativeness of settings and intervention agents (people who deliver the program) who are willing to initiate a program.
In the case of this study, adoption is measured by finding out the proportion of doctors that agree to deliver the intervention by calculating the number of doctors participated over the total number of doctors involved.
Measured: Through study completion, an average of 1 year
Implementation
At the setting level, implementation refers to the intervention agents' fidelity to the various elements of an intervention's protocol, including consistency of delivery as intended and the time and cost of the intervention.
At the individual level, implementation refers to clients' use of the intervention strategies.
Implementation will be assessed by exploring engagement with key components of the CareAide® app. Engagement will be assessed by looking through the app analytics data to see the frequency of usage of various app key components.
Measured: At three months and at 24 weeks after the intervention
Maintenance
The extent to which a program or policy becomes institutionalized or part of the routine organizational practices and policies.
At the individual level, maintenance has been defined as the long-term effects of a program on outcomes after 6 or more months after the most recent intervention contact.
This outcome will measure doctors' and patients' willingness to continue with the app, ease of use, perceived value of each program component, an overall rating of the program, and whether or not they would recommend the app use to others through the means of a self-report section on a questionnaire.
The System Usability Scale (Brooke, 1986) will also be administered to assess the usability of the App. The scale has a minimum score of 10 and a maximum score of 100. The higher the score, the higher the perceived usability of the CareAide® Medication Adherence Mobile Application.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start30 Apr 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779591
- Sponsor's protocol ID
- 2024724-13968
- Other IDs
- 2024724-13968
- Status last verified
- Mar 2025
- First submitted
- 1 Jan 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effectiveness of the Medication Adherence "CareAide® App" for People with Cardiometabolic Diseases At an Academic Primary Care Clinic in Malaysia: a Hybrid Implementation-effectiveness Study
- ClinicalTrials.gov ID
- NCT06779591
- Acronym / sponsor ID
- 2024724-13968
- Conditions
- Hypertension, Diabetes Mellitus Type 2, Dyslipidemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 30 Apr 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jan 2025 (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.
This study aims to explore the barriers and facilitators to implement CareAide® app among healthcare providers and patients at a primary care clinic in Malaysia.
This is an implementation-qualitative research study meaning researchers will collect data regarding the adoption rate, ease of implementation and adoption, and patient's willingness to use the application. The researchers will also compare the effectiveness of the application as a tool to remind patients to take their medicine, by comparing between a group of participants who use the app and another group of participants who do not use the app.
This study requires participants to use an app, then attend some routine follow-ups and be administered blood tests, followed by an interview to collect their opinions, feelings, and experiences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: CareAide® Medication Adherence Mobile ApplicationIntervention group participants will receive 24 weeks of free, unlimited access to the CareAide® app. The CareAide® app will help the intervention group track their medication, view health statistics, help in remote management, act as a health diary, act as a virtual drug cabinet, access medical record files, educate patients and their families, and foster community among afflicted patients. Participants will be assisted by the study coordinator to download the App onto their smartphones and how to navigate the app upon recruitment. They will be asked to use the app to manage their medications for a period of 24 weeks. Participants in the IG will participate in the use of the app for from 0 to 24 weeks while the control group will continue with their usual routine. Assessment of adherence levels and pertinent clinical outcomes is scheduled at the end of 24 weeks of the intervention following the enrolment of participants for both study groups. |
| Control Group | No intervention | –Participants in the control group will continue with their usual routine without being aware of the existence of the app. Assessment of adherence levels and pertinent clinical outcomes is scheduled at the end of 24 weeks of the intervention following the enrolment of participants for both study groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Above 18 years old
- Medically diagnosed with either hypertension, type 2 diabetes and dyslipidemia for at least 6 months as listed in electronic health records
- Exhibit a low adherence indicated by Malaysia Medication Adherence Assessment Tool (MyMAAT) scores of <54 scores
- Taking at least one type of medication daily, three medications daily or two medications with multiple dosing intervals prescribed,
- Owns and able to use a smartphone
Key exclusion criteria (1 listed)
- Individuals who are pregnant, already using any adherence apps or diagnosed with any terminal illnesses, visually impaired, disability or mental health related illnesses
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 |
|---|---|---|
| CareAide® Medication Adherence Mobile ApplicationCareAide® app is one of the mobile apps in assisting and improving patients' adherence to medications. It is an unique health-tech and insure-tech company with expertise in behavioural science, chronic condition management and technology. The app aims to help patients with chronic conditions live a better everyday life and empower their families and the ecosystem around the patients to drive better outcomes. They have the clinically validated approach to improving adherence. Using behavioural science and smart tech, they improve the day-to-day life of patients, and importantly, empower both patients and health care providers with the digital tools and near real-time insights to proactively manage risks, intervene early to avoid patient emergencies and to help to provide a better customer satisfaction. | Other | Intervention Group |
Primary outcome
Reach
Time frame: Before the start of intervention
The absolute number, proportion, and representativeness of individuals who are willing to participate in a given initiative, intervention, or program. A proxy for reach was used and defined as the percentage of patients who gave informed consent to participate out of all patients approached.
Effectiveness
Time frame: Before the start of the intervention, and at 24 weeks after the intervention
The impact of CareAide® app on medication adherence using the Malaysia Medication Adherence Assessment Tool (MyMAAT) score, with 12 points being the minimum score and 60 points being the maximum. Patients are classified as moderate \& poor adherence if their score is < 54. Patients have good adherence if their score is ≥ 54.
Effectiveness
Time frame: Before the start of the intervention, and at 24 weeks after the intervention
The impact of CareAide® app on hypertension, measured by taking the patient's systolic and diastolic blood pressure in mmHg.
Effectiveness
Time frame: Before the start of the intervention, and at 24 weeks after the intervention
The impact of CareAide® app on type 2 diabetes by measuring the patient's fasting blood glucose (mmol/L) and HbA1c (%).
Effectiveness
Time frame: Before the start of the intervention, and at 24 weeks after the intervention
The impact of CareAide® app on dyslipidaemia outcomes, measured by taking the patient's total cholesterol (mmol/L), low-density lipoprotein (mmol/L), high density lipoprotein (mmol/L), and triglyceride level (mmol/L).
Adoption
Time frame: Through study completion, an average of 1 year
The absolute number, proportion, and representativeness of settings and intervention agents (people who deliver the program) who are willing to initiate a program. In the case of this study, adoption is measured by finding out the proportion of doctors that agree to deliver the intervention by calculating the number of doctors participated over the total number of doctors involved.
Implementation
Time frame: At three months and at 24 weeks after the intervention
At the setting level, implementation refers to the intervention agents' fidelity to the various elements of an intervention's protocol, including consistency of delivery as intended and the time and cost of the intervention. At the individual level, implementation refers to clients' use of the intervention strategies. Implementation will be assessed by exploring engagement with key components of the CareAide® app. Engagement will be assessed by looking through the app analytics data to see the frequency of usage of various app key components.
Maintenance
Time frame: Through study completion, an average of 1 year
The extent to which a program or policy becomes institutionalized or part of the routine organizational practices and policies. At the individual level, maintenance has been defined as the long-term effects of a program on outcomes after 6 or more months after the most recent intervention contact. This outcome will measure doctors' and patients' willingness to continue with the app, ease of use, perceived value of each program component, an overall rating of the program, and whether or not they would recommend the app use to others through the means of a self-report section on a questionnaire. The System Usability Scale (Brooke, 1986) will also be administered to assess the usability of the App. The scale has a minimum score of 10 and a maximum score of 100. The higher the score, the higher the perceived usability of the CareAide® Medication Adherence Mobile Application.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareAide® Medication Adherence Mobile Application in people with Hypertension and Diabetes Mellitus Type 2, run by University of Malaya at 1 site in Malaysia.
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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 Mar 2025. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hooi Chin Beh (+60124438038, hcbeh@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (time frame: Before the start of intervention). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2025.