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

Not Applicable

Not yet recruiting

• Conditions: Hypertension; Diabetes Mellitus Type 2; Dyslipidemia

• Registration Number: NCT06779591
• Lead Sponsor: University of Malaya

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-12
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Start: 2025-04-30
• Primary Completion: 2025-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reach	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	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	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	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	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.

Trial Locations

Locations (1)

Universiti Malaya Medical Centre; 🇲🇾 Petaling Jaya, Wilayah Persekutuan Kuala Lumpur, Malaysia