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

NCT06779591 | Not Yet Recruiting

• 1 other identifier: 2024724-13968
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Diabetes Mellitus Type 2; Dyslipidemia

Outcome Measures

Primary Outcomes (8)

• Reach

  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.

  Before the start of intervention

• Effectiveness

  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.

  Before the start of the intervention, and at 24 weeks after the intervention

• Effectiveness

  The impact of CareAide® app on hypertension, measured by taking the patient's systolic and diastolic blood pressure in mmHg.

  Before the start of the intervention, and at 24 weeks after the intervention

• Effectiveness

  The impact of CareAide® app on type 2 diabetes by measuring the patient's fasting blood glucose (mmol/L) and HbA1c (%).

  Before the start of the intervention, and at 24 weeks after the intervention

• Effectiveness

  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).

  Before the start of the intervention, and at 24 weeks after the intervention

• Adoption

  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.

  Through study completion, an average of 1 year

• Implementation

  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.

  At three months and at 24 weeks after the intervention

• Maintenance

  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.

  Through study completion, an average of 1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: CareAide® Medication Adherence Mobile Application

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Universiti Malaya Medical Centre

Petaling Jaya, Kuala Lumpur, 50603, Malaysia

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2; Dyslipidemias

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Central Study Contacts

Hooi Chin Beh

CONTACT

+60124438038; hcbeh@ummc.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 16, 2025
• Study Start: April 30, 2025
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)