Hyperlipidemia, Hypertension, Ischemic Cardiovascular Disease
Conditions
Brief summary
This study aims to: 1. Investigate the impact of MED-AD intervention on medication adherence among CVD patients, compared to patients receiving text message reminders or routine care alone at baseline, 6 months, and 12 months later. 2. Evaluate the effectiveness of MED-AD intervention on clinical outcomes among patients with CVD, compared to the outcomes of patients receiving text or routine care alone at baseline, 6 months, and 12 months later. This study is a prospective randomized controlled clinical trial (RCT) with three arms: 1. MED-AD intervention: MED-AD is a smartphone application that will use the following strategies (pill reminders, Medication Adherence Report, medication intake confirmation, Medical Appointment Reminder, and educational notifications) to enhance medication adherence 2. Text message reminders: Participants will receive short text message (SMS) reminders to remind them to take medications as prescribed once daily 3. Routine care only: Participants will receive routine care that does not include text messages or reminders and education through an application.
Interventions
BEHAVIORALsmartphone application (MED-AD)
1. Medication Reminders: The oral medication list of the patient (names, doses, times, and frequency of administration) will be entered manually in the application by the RA in agreement with the patient during the medication prescription refill. This application will then send reminders, as notifications and voice notes, to take medications. An example of the reminder is "take lisinopril, one tablet, 10 mg at 9:00 am." The reminders will be categorized as normal, urgent \& critical. Normal is a reminder sent on the normal medication timing. An urgent reminder is when the patient misses confirming a reminder more than once, which will be set as an alert on the phone. Critical reminder is when the patient misses confirming a reminder multiple times, which will be as an alert or an alarm on the phone. In addition, the application will notify a family member in case of urgent and critical reminders. 2. Medication Adherence Report: The application will generate a weekly report on medication
BEHAVIORALShort Text-message Reminders
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.
Sponsors
Sultan Qaboos University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. diagnosed with at least one CVD (i.e., HTN, IHD, hyperlipidemia), 2. prescribed at least one medication for at least one year, 3. Omanis aged 18 years or older, 4. registered in the selected healthcare center, and 5) agreed to participate in the study
Exclusion criteria
1. have a severe cognitive impairment, 2. are unable to provide informed consent, 3. cannot read, and 4) do not have a smartphone with a compatible operating system (ios or Android).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Refills and Medications Scale | BASELINE, AT 6 MONTHS, AT 12 MONTHS | 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. |
| The Proportion of Days Covered | BASELINE, AT 6 MONTHS, AT 12 MONTHS | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes | BASELINE, AT 6 MONTHS, AT 12 MONTHS | 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\[troponin I\]) |
Countries
Oman
Outcome results
None listed