Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman

Not Applicable

Not yet recruiting

• Conditions: Ischemic Cardiovascular Disease; Hypertension; Hyperlipidemia

• Registration Number: NCT06951451
• Lead Sponsor: Sultan Qaboos University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-20
• Study First Submitted QC: 2025-04-26
• Last Update Submitted: 2025-04-26
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30
• Study Start: 2025-06-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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\[troponin I\])

Trial Locations

Locations (1)

Ministry of Health; 🇴🇲 Muscat, Oman