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NCT Number: NCT06779591

Implementation and Effectiveness of "CareAide® App" for People with Cardiometabolic Diseases At a Primary Care Clinic

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Individuals who are pregnant, already using any adherence apps or diagnosed with any terminal illnesses, visually impaired, disability or mental health related illnesses

Treatment and study plan

CareAide® Medication Adherence Mobile Application

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 (%).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hooi Chin Beh

CONTACT

[email protected]

+60124438038

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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