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

University of Malaya

Status: Not yet enrolling

Conditions: Hypertension; Diabetes Mellitus Type 2; Dyslipidemia

Treatments: Other: CareAide® Medication Adherence Mobile Application

Study type: Interventional

Funder types: Other

Identifiers

NCT06779591

2024724-13968 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: CareAide® Medication Adherence Mobile Application

Control Group

No Intervention group

Description:

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.