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| ID | Type | Description | Link |
|---|---|---|---|
| UM.0000532/HPV.PV | Other Grant/Funding Number | Caring Up Malaysia Pte. Ltd., 50470 Kuala Lumpur. Malaysia |
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| Name | Class |
|---|---|
| Caring Up Pte Ltd, Malaysia | UNKNOWN |
| Institute of Adherence to Medication, American University of Health Sciences, United States | UNKNOWN |
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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:
Researchers will ask the participants to use the CareAide app for 6 months and compare the group that used the app with the other group which just received the usual treatment. Researchers will check if they do better with their medications, feel healthier, have a better life, and spend less money. They will check this twice, once after 3 months and again after 6 months.
adherence, clinical outcomes, quality of life and economic associated with the app with two follow ups at 3 month intervals.
According to WHO and Ministry of Health (MOH) Malaysia 2020 report, expenditure for chronic diseasesestimated involved around 0.65% of Malaysia's gross domestic product (GDP) which is about RM8.91 billion (Ministry of Health Malaysia, 2020). This showed that chronic diseases imposed a significant healthburden to our country. Malaysian population having good and easy access to effective medical therapyunder the public healthcare system, approximately 46% to 56% of patients with hypertension were non-adherent in terms of their medications. Therefore, CareAide App will be used to study and identify the effect, clinical outcome and cost effectiveness of mobile health app in managing chronic diseases.
The Comprehensive Adherence-enhancing Reminder and Engagement Aide (CAREAide) Trial aims to assess the effect of CareAide® app on adherence, clinical outcomes of patients with chronic diseases and user's perception and satisfaction with the app.
A 3-and 6- month open-label multicentre randomized controlled trial with two parallel groups will be conducted. This study will take place in the outpatient setting of the three hospitals [i.e., Hospital Putrajaya, Hospital Pulau Pinang and Universiti Malaya Medical Center (UMMC)) in Malaysia]. Both interventional and control group will be allocated to 1:1 ratio. Randomization number will be generated by using online number generated programme. Consultants reviewing patients at medical, cardiology,diabetes mellitus and asthma clinics will provide referral and notify independent researchers for eligibility and group assignments. Eligible patients will then be instructed to see pharmacists/researchers atoutpatient pharmacies to refill their prescriptions and subsequently enrol in the assigned study group either to receive an intervention with CareAide® or to receive normal clinical care. Information and training on the app will be provided by these researchers to the participants.Patients will be recruited at therespective outpatient clinics. At the usual care clinic appointments, patients have their demographics and baseline data of blood pressure, blood sugar, basic blood profiles, asthma control and review of theirdisease management collected by consultants/researchers. Patients who meet the study criteria will then be instructed to see pharmacists/researchers at outpatient pharmacy to refill their medications. The pharmacists/researchers will screen patients' inclusion and exclusion criteria for this study and will explainthat they may or may not be selected for the study and if they agree, proceed to provide written informedconsent. The adherence data from the screening will be collected to gauge the general adherence rate inthese group of patients. An independent researcher, who is not involved in the intervention and controlgroups, will use the random number generator software for randomisation sequences. The random numbers will be placed in opaque envelopes, which subsequently will be opened by pharmacists/researchers at the outpatient pharmacies. Participants and pharmacists/researchers are unblinded to group assignment and are aware of the intervention, but the study hypotheses are not disclosed to the participants. The assessor and statisticians are blinded to participant allocation. The study will be evaluating usual care compared with usual care plus pharmacist-driven patient-specific adherence interventions - CareAide® medication adherence digital application. Usual care provided bythese hospitals comprises clinic appointments every 3 to 6 months. Medication adherence: CareAide® effectiveness is measured with a medication adherence tool at baseline and follow-up time periods at 3months and 6 months using Morisky Medication Adherence Scale (MMAS) and proportion of days covered (PDC). MMAS-8 is a licensed validated questionnaire to assess medication adherence, where a higher score represents higher medication adherence and vice versa. Comprising of 8 items, the score ranges from 0 to 8, where a higher score represents a higher medication adherence. The internal consistency (Cronbach's alpha) of MMAS-8 is 0.83 along with a sensitivity of 93% and a specificity of 57%.
The PDC method utilises pharmacy refill records. Fasting blood sugar, HbA1C, cardiovascular events (heart failure admission, mortality), asthma control and blood pressure, hospitalizations and emergency visits measurements will be based on the clinics attended by the participants. Health care utilization, quality of life and health care expenditures willbe measured for all the participants.
Intention to treat (ITT) analysis will be applied to evaluate the results to avoid any bias. The data analysiswill be using the SPSS version 29. Data will be coded and analysed. Descriptive or categorical data will beexpressed as mean ± standard deviation (SD) unless otherwise stated. Student t-test will be used foranalysis of normally distributed or continuous variables. Mann-Whitney test will be used for non-normallydistributed data. Categorical data will be analysed using Chi-square or Fischer's exact test. A value of P <0.05 is considered statistically significant.
The prevalence of medication compliant is quantified at 3 months and 6 months follow-up. Independent t-test or Mann-Whitney test will be used to compare MMAS score rankings between the intervention andcontrol groups. Chi-Square test of independence will be used to determine the difference in number ofpatients with medication adherence between the intervention and control groups at 3 months and 6months follow-up. Ordinal logistic regression, with the MMAS adherence score ranking, will be used to examine the association between intervention and control groups.
For the perception and satisfaction towards the app, the frequency and percentage of respondents in each category (strongly disagree to strongly agree) will be calculated. The median of each statement will then be calculated to give an overview of perception and satisfaction towards the CareAide® app. Chi-square, Mann-Whitney U, Kriskall Wallis, Chi-square tests and logistic regression will be used where appropriate. Linear regression analysis will be conducted to determine the independent predictors of HRQoL.
An economic evaluation will be conducted from a payer and societal perspective. Costs and outcomes will be discounted at 3% per year as the results will be extrapolated to examine costs and outcome over a year. Cost effectiveness analysis will be estimated based on the results of cost data and the incremental cost per quality adjusted life year (QALY) gained. Total incremental cost effectiveness ratio (ICER) will be calculated by dividing the difference between the cost of CareAide intervention group and control group by the difference between the QALYs of CareAide intervention group and control group. Sensitivity analysis will be performed by bootstrapping technique to ensure or examine the robustness of ICER. Then, cost effectiveness acceptability curve (CEAC) will be created to estimate the proportion of the result being cost-effective in relation to the Willingness-to-Pay (WTP) threshold.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | Participants allocated to the Control group (CG) receives prescibed usual therapeutic care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareAide App Usage | Other | The study participant uses the CareAide app in addition to prescribed usual therapeutic care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Parameter of Hypertension: Blood Pressure | Hypertensive clinical parameters, Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) are measured, where SBP (≥140 mm Hg); DBP (≥90 mm Hg) levels are considered Hypertensive. | 6 Months |
| Clinical Parameter of Heart Failure: Ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Pulau Pinang | George Town | Pulau Pinang | 10450 | Malaysia | ||
| University Malaya Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21397776 | Background | Asche C, LaFleur J, Conner C. A review of diabetes treatment adherence and the association with clinical and economic outcomes. Clin Ther. 2011 Jan;33(1):74-109. doi: 10.1016/j.clinthera.2011.01.019. | |
| Background | Baker-Eveleth, L., & Stone, R. W. (2020). User's perceptions of perceived usefulness, satisfaction, and intentions of mobile application. International Journal of Mobile Communications, 18(1), 1-18. | ||
| 24049221 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jul 30, 2022 | Sep 28, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D002908 | Chronic Disease |
| D000086522 | Financial Stress |
| D001249 | Asthma |
| D006973 | Hypertension |
| D006333 | Heart Failure |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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Ejection fraction (EF) is a measurement, expressed as a percentage, of how much blood the left ventricle pumps out with each contraction. It is classified as Reduced (EF≤40%); Borderline (EF≈41-49%); Normal (EF≈50-70%). |
| 6 Months |
| Clinical Parameter of Diabetes: Glycated hemoglobin | Glycated hemoglobin (HbA1c) is measured for diagnosis of Diabetes, where a patient with HbA1c >6.5% is considered Diabetic. | 6 Months |
| Clinical Parameter of Diabetes: Glucose levels | Glucose levels, specifically Fasting blood glucose (FBG) (>125 mg/dL), Random blood glucose (RBG) (>200 mg/dL) and Post-Prandial blood glucose PPBG at 2 hours (>200 mg/dl) are indicative of diabetic. | 6 Months |
| Clinical Parameter of Asthma: Forced Expiratory Volume in 1 second | Forced expiratory volume in 1 second (FEV1) is the maximum amount of air that the subject can forcibly expel during the first second following maximal inhalation. A patient is considered a high risk if FEV1 is less than 60% and Low risk if his FEV1 is more than 60%. | 6 Months |
| Clinical Parameter of Asthma: Peak Expiratory Flow | Peak expiratory flow (PEF) is the maximum flow rate (expressed in liters per minute [L/min]) generated during a forceful exhalation, starting from full inspiration. It is classified as Persistent Asthma with symptoms (Severe Persistent (PEF<60%); Moderate Persistent (PEF 60-79%); Mild Persistent (PEF>80%), Intermittent Asthma without symptoms (PEF>80%)) | 6 Months |
| Clinical Parameter of Asthma: Asthma Control Questionnaire-7 (ACQ-7) Score | The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). It classifies asthma control as well controlled (≤0.75); Inadequately controlled (≥1.5); Minimal important difference (0.5). | 6 Months |
| Total Medical Cost | Total Medical Cost will be calculated in Malaysia currency, Ringgit Malaysia (RM). It will involve direct, indirect, and intangible costs. Direct cost refers to the costs incurred because of medical management of the disease, drugs, admissions, complementary tests, patient transportation. The Indirect costs refers to the costs incurred not as a result of medical management of the disease but rather of other incurred losses such as lost wages, lost productivity, and costs resulting from the need for home care and child care that would otherwise not be incurred. Intangible costs are those associated with the function lost, increased pain and reduced life quality. | 6 Months |
| Incremental Cost-Effectiveness Ratio (ICER) | The ICER is calculated as the difference in the expected costs of the two health interventions i.e. CareAide app users with usual therapeutic care versus only usual therapeutic standard care, divided by the difference in their expected effects i.e. improvement in adherence (QALYs). | 6 Months |
| Health-related quality of life (HRQoL): EuroQol-5D (EQ-5D-5L) Questionnaire | The EQ-5D-5L comprises two pages: the descriptive system (five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression; each with five levels) and the EQ VAS (a vertical scale indicating self-rated health from 'best health imaginable' to 'worst health imaginable'). The patient marks their health state by choosing a statement for each dimension, resulting in a 5-digit number. The EQ VAS serves as a quantitative measure of the patient's health judgment.. | 6 Months |
| Health-related quality of life (HRQoL): Short-form (SF-36) Survey Instrument | A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The self-administered SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. | 6 Months |
| Perception & Satisfaction Questionnaire (PSQ) | Only the participants using the CareAide® app will be given Perception & Satisfaction Questionnaire (PSQ) at the end of 6 months follow up to understand the participant's perception of the perceived usefulness of the app and rate their satisfaction with the app. The questionnaire will be divided into three sections to specify the type of questions to be asked. The first section consists of basic demographics, including age, gender, ethnicity, personal health status, and the number of medications taken. Section two includes questions to explore the perception of the users towards the app. Section three consists of a questionnaire to rate their satisfaction with the app. The responses will be measured using a 5-point Likert scale with score ranging from 1 (Inadequate) to 5 (Excellent) | 6 Months |
| 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 |
| Kuala Lumpur |
| 59100 |
| Malaysia |
| Hospital Putrajaya | Putrajaya | 62250 | Malaysia |
| Background |
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| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |