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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06779591
Enrollment
200
Registered
2025-01-16
Start date
2025-04-30
Completion date
2026-12-31
Last updated
2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, Dyslipidemia, Hypertension

Brief 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, 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.

Interventions

OTHERCareAide® Medication Adherence Mobile Application

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.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ReachBefore the start of interventionThe 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.
EffectivenessBefore the start of the intervention, and at 24 weeks after the interventionThe 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.
AdoptionThrough study completion, an average of 1 yearThe 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.
ImplementationAt three months and at 24 weeks after the interventionAt 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.
MaintenanceThrough study completion, an average of 1 yearThe 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.

Countries

Malaysia

Contacts

Primary ContactHooi Chin Beh
hcbeh@ummc.edu.my+60124438038

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026