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

Официальное название

Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman: A Multicenter Randomized Clinical Trial

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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.

Первичные конечные точки

• Adherence to Refills and Medications Scale [Срок оценки: BASELINE, AT 6 MONTHS, AT 12 MONTHS]
• The Proportion of Days Covered [Срок оценки: BASELINE, AT 6 MONTHS, AT 12 MONTHS]

Вторичные конечные точки (1)

• Clinical outcomes [Срок оценки: BASELINE, AT 6 MONTHS, AT 12 MONTHS]

Критерии участия

Критерии включения

• diagnosed with at least one CVD (i.e., HTN, IHD, hyperlipidemia),
• prescribed at least one medication for at least one year,
• Omanis aged 18 years or older,
• registered in the selected healthcare center, and 5) agreed to participate in the study

Критерии исключения

• have a severe cognitive impairment,
• are unable to provide informed consent,
• cannot read, and 4) do not have a smartphone with a compatible operating system (ios or Android).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Oman · 1 центр

• Ministry of Health — Muscat

Идентификаторы

NCT: NCT06951451 · MoH/CSR/22/26909

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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