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This study aims to:
This study is a prospective randomized controlled clinical trial (RCT) with three arms:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MED-AD application | Experimental | MED-AD is a smartphone application that will use two strategies (pill reminders and educational notifications) to enhance medication adherence. Both methods have shown their effectiveness in independently improving medication adherence; however, combining two or more strategies maximizes the efficacy of improving adherence. In addition, this application will be unique as it allows the patient to engage with their self-management behaviors and get feedback about their performance. The research team will develop the smartphone application with an expert in the application development field. In addition, the research team will pilot the MED-AD application on the same population and modify it before implementation of the study. The application will be hosted on SQU's in-house data, which is hosted and managed by the Center for Information Systems. |
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| Short Text-message Reminders | Active Comparator | Participants will receive short text messages (SMS) to remind them to take medications as prescribed once daily. However, unlike the application reminders, the SMS will be general and not specify taking particular medicines. An example of the SMS message will be, "Remember to take your medicines for the day?" The research team will pilot the MED-AD application on the same population and modify it before implementing the study. |
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| Routine care | No Intervention | Participants will receive routine care that does not include text messages or reminders and education through an application. In primary health care centers, the current routine care for people with chronic disease consists of the physical attendance of patients to their pre-scheduled medical appointment. The medical appointment will be every three months for most regular and controlled cases. The health care provider will usually evaluate the patient's condition, including the disease progression and medication adherence, and compare that with clinical parameters and laboratory investigations. Medications will be prescribed for the next three months, but the dispensing will be monthly. Patients will come every month directly to the pharmacy for a medication refill. The pharmacist will check the time window for medication refills and dispense the prescribed medications for one month. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smartphone application (MED-AD) | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Refills and Medications Scale | This instrument includes 12 items divided into two subscales: 8 items on the medication-taking subscale and four items on the refill subscale. The items are scored on a 4-point Likert scale with ranges of 1 = ''none of the time'' to 4 = ''all of the time.'' The total score is the sum of all items, ranging from 12 to 48, with lower scores representing better medication adherence. | BASELINE, AT 6 MONTHS, AT 12 MONTHS |
| The Proportion of Days Covered | This measure is one of the objective, indirect instruments used to measure adherence. It calculates the number of days "covered" over the total number of days in the same period. Proportion of days covered = Days Supply of medication dispensed to the patient/ Total number of days X 100% The scoring is always positive and ranges from 0 to 100%. Zero means no adherence, while a PDC of 100% indicates perfect adherence. The threshold is the level that provides a reasonable likelihood of achieving the clinical benefits of therapy. For patients with cardiovascular diseases (CVD), clinical evidence supports using 80% as a standard PDC threshold. | BASELINE, AT 6 MONTHS, AT 12 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes | laboratory findings (i.e., Blood pressure, Cholesterol level, triglyceride levels, LDL, HDL, Ejection fraction, GFR), and cardiovascular complications in the previous three months (i.e., heart failure, dysrhythmias, strokes, heart attacks, Catheterization, ED visits, hospitalization, LOS if hospitalized, cardiac enzymes[troponin I]) | BASELINE, AT 6 MONTHS, AT 12 MONTHS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ministry of Health | Muscat | Oman |
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The study protocol will be made available upon reasonable request beginning 3 months after the primary results are published. Requests must include a methodologically sound proposal and will be subject to review.
Qualified researchers affiliated with academic, healthcare, or research institutions can access the study protocol only; no individual participant data (IPD) will be shared. The protocol includes detailed information about the study design, objectives, and methodology. It will be made available upon reasonable request starting three months after publication of the primary study results. Access will be granted following a brief review process to ensure appropriate use, and the document will be shared through secure institutional email or document-sharing platforms.
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| Short Text-message Reminders | Behavioral | Participants will receive short text message (SMS) reminders to remind them to take medications as prescribed ONCE daily. However, the SMS will be general and not specify taking particular medicine compared to the application reminders. An example of the SMS message will be "Remember to take your medicines of the day?" The research team will pilot the MED-AD application on the same population and modify it before the implementation of the study. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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