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

NCT ID: NCT06951451

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-07-30

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.

Conditions

Ischemic Cardiovascular Disease; Hypertension; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

MED-AD application

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.

Group Type: EXPERIMENTAL

smartphone application (MED-AD)

Intervention Type: BEHAVIORAL

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

Short Text-message Reminders

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.

Group Type: ACTIVE_COMPARATOR

Short Text-message Reminders

Intervention Type: 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.

Routine care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

smartphone 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

Intervention Type: BEHAVIORAL

Short 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sultan Qaboos University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Huda Al Noumani

Associate Professor, Department of Adult Health and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ministry of Health

Muscat, , Oman

Countries

Oman

Central Contacts

Huda Al-Noumani

Role: CONTACT

hudasn@squ.edu.om

+968024145400

Facility Contacts

Huda Al-Noumani

Role: primary

hudasn@squ.edu.om

024145400

Other Identifiers

MoH/CSR/22/26909

Identifier Type: -

Identifier Source: org_study_id