Clinical trial NCT06779591: Implementation and Effectiveness of "CareAide® App" for People with Cardiometabolic Diseases At a Primary Care Clinic
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Diabetes Mellitus Type 2
Dyslipidemia
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reach
timeFrame: Before the start of intervention
measure: Effectiveness
timeFrame: Before the start of the intervention, and at 24 weeks after the intervention
measure: Effectiveness
timeFrame: Before the start of the intervention, and at 24 weeks after the intervention
measure: Effectiveness
timeFrame: Before the start of the intervention, and at 24 weeks after the intervention
measure: Effectiveness
timeFrame: Before the start of the intervention, and at 24 weeks after the intervention
measure: Adoption
timeFrame: Through study completion, an average of 1 year
measure: Implementation
timeFrame: At three months and at 24 weeks after the intervention
measure: Maintenance
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Universiti Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
References: