Efficacy of CareAide® App in Improving Adherence in Adults With Chronic Diseases

NCT06068309 | Completed DMC

• 2 other identifiers: NMRR ID-22-01108-COIUM.0000532/HPV.PV
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to study the impact of a medication adherence app, CareAide, in adult population diagnosed with chronic diseases in Malaysian population. The main question\[s\] it aims to answer are:

1. 1.Can CareAide make people take their medications better and improve their health?
2. 2.Can CareAide improve the health of people with chronic diseases?
3. 3.Does using CareAide make people's lives better?
4. 4.Can CareAide save money when managing chronic diseases?
5. 5.How do people feel about using CareAide?

Conditions

Adherence, Medication; Chronic Disease; Quality of Life; Economic Burden; Asthma; Hypertension; Heart Failure; Diabetes

Keywords

randomized controlled trial; mobile health app; digital health; medication adherence app; Patient perception; CareAide; clinical outcomes; Malaysia; adherence

Outcome Measures

Primary Outcomes (2)

• Morisky Medication Adherence Scale (MMAS) Score

  Adherence measured by the 8-item Morisky Medication Adherence Scale (MMAS-8) where a scoring is as defined as, Low Adherence (0\< 6); Medium Adherence (6 to \<8); High Adherence (= 8)

  6 Months

• Proportion of days covered (PDC)

  Adherence is measured by Proportion of days covered (PDC) which measures the proportion of days in which a subject has access to their medication over a specified period of time (POI). It is calculated as the (sum of days covered in the POI) ÷ (number of days in the POI) × 100, Scoring is defined as, High adherence (\>80%); Medium Adherence (50%-80%); Poor adherence (\<50%)

  6 Months

Secondary Outcomes (12)

• Clinical Parameter of Hypertension: Blood Pressure

  6 Months

• Clinical Parameter of Heart Failure: Ejection fraction

  6 Months

• Clinical Parameter of Diabetes: Glycated hemoglobin

  6 Months

• Clinical Parameter of Diabetes: Glucose levels

  6 Months

• Clinical Parameter of Asthma: Forced Expiratory Volume in 1 second

  6 Months

Study Arms (2)

CareAide Interventional Group

EXPERIMENTAL

Participants allocated to the Interventional group (IG) uses the CareAide® app on their smartphones in addition to prescribed usual therapeutic care.

Other: CareAide App Usage

Control Group

NO INTERVENTION

Participants allocated to the Control group (CG) receives prescibed usual therapeutic care

Interventions

CareAide App Usage OTHER

The study participant uses the CareAide app in addition to prescribed usual therapeutic care

CareAide Interventional Group

Eligibility Criteria

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

You may qualify if:

• Age: 18 years and above
• Diagnosed with selected non-communicable diseases (NCDs): hypertension, diabetes mellitus, heart failure or asthma for at least 6 months
• Prescription generated from one of the following specialty clinics: Medical, Cardiology, Diabetes Mellitus or Asthma clinics of study site.
• Medications are prescribed in previous 3 months and refill at the point of recruitment
• Morisky Medication Adherence Scale (MMAS) score \< 6 (i.e. Low adherence)
• More than three medications daily or two medications with multiple dosing intervals.
• One or more hospital admissions in the prior 24 months
• Owns a smartphone

You may not qualify if:

• Medications prescribed from other institution providers
• Existing mobile health app or medication reminder app user
• Pregnant
• Cognitively impaired
• Prisoners
• Bed-bound
• Severe diseases/comorbidities - terminal cancer, psychiatry, etc

Sponsors & Collaborators

• University of Malaya: lead
• Caring Up Pte Ltd, Malaysia: collaborator
• Institute of Adherence to Medication, American University of Health Sciences, United States: collaborator

Study Sites (3)

Hospital Pulau Pinang

George Town, Pulau Pinang, 10450, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Hospital Putrajaya

Putrajaya, 62250, Malaysia

Location

Related Publications (22)

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MeSH Terms

Conditions

Medication Adherence; Chronic Disease; Financial Stress; Asthma; Hypertension; Heart Failure; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ong Siew Chin, PhD

  School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), Penang, Malaysia

  PRINCIPAL INVESTIGATOR

• Navin Kumar Loganadan, PhD

  Hospital Putrajaya, Malaysia

  PRINCIPAL INVESTIGATOR

• Jaya Muneswarao M Devudu

  Hospital Pulau Pinang, Malaysia

  PRINCIPAL INVESTIGATOR

• Izyan A Wahab, PhD

  Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

• Kayatri Govindaraju, PhD

  Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

• Rajat Rana, Pharm.D

  Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

• Ng Chow Kyn, MPharm Clin

  School of Pharmaceutical Sciences, Universiti Sains Malaysia (USM), Penang, Malaysia

  PRINCIPAL INVESTIGATOR

• Mohamed Syamir Shukeri, MCH

  Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

• Baharudin Ibrahim, PhD

  Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

• Hasniza Zaman Huri, PhD

  Faculty of Pharmacy, University of Malaya, 50603 Kuala Lumpur, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Researcher

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 5, 2023
• Study Start: July 30, 2022
• Primary Completion: June 30, 2024
• Study Completion: September 6, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

MY (3)