Hypertension Clinical Trial
— CAREAideOfficial title:
Perception, Adherence, Clinical, Economical and Health-Related Quality of Life Outcomes of CareAide® App Usage in Chronic Diseases
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. Can CareAide make people take their medications better and improve their health? 2. Can CareAide improve the health of people with chronic diseases? 3. Does using CareAide make people's lives better? 4. Can CareAide save money when managing chronic diseases? 5. How do people feel about using CareAide? 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.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | December 31, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Pulau Pinang | George Town | Penang |
Malaysia | University Malaya Medical Centre | Kuala Lumpur | |
Malaysia | Hospital Putrajaya | Putrajaya |
Lead Sponsor | Collaborator |
---|---|
University of Malaya | Caring Up Pte Ltd, Malaysia, Institute of Adherence to Medication, American University of Health Sciences, United States |
Malaysia,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Clinical Parameter of Heart Failure: Ejection fraction | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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