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

Sultan Qaboos University

Status: Not yet enrolling

Conditions: Hypertension; Hyperlipidemia; Ischemic Cardiovascular Disease

Treatments: Behavioral: smartphone application (MED-AD); Behavioral: Short Text-message Reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT06951451

MoH/CSR/22/26909

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,000 participants in 3 patient groups

MED-AD application

Experimental group

Description:

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.

Treatment:

Behavioral: smartphone application (MED-AD)

Short Text-message Reminders

Active Comparator group

Description:

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.

Treatment:

Behavioral: Short Text-message Reminders

Routine care

No Intervention group

Description:

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.