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Enrolling by invitation NCT06951451

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

No phase Interventional Ischemic Cardiovascular Disease Hypertension Hyperlipidemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: smartphone application (MED-AD), Short Text-message Reminders.
Who it may be relevant to
Registry conditions: Ischemic Cardiovascular Disease, Hypertension, Hyperlipidemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Oman
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Behavioral 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
  • 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.

Primary outcome measures

  • Adherence to Refills and Medications Scale [Time frame: BASELINE, AT 6 MONTHS, AT 12 MONTHS]
  • The Proportion of Days Covered [Time frame: BASELINE, AT 6 MONTHS, AT 12 MONTHS]
Secondary outcome measures (1)
  • Clinical outcomes [Time frame: BASELINE, AT 6 MONTHS, AT 12 MONTHS]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Oman · 1 center
  • Ministry of Health — Muscat

Identifiers

NCT: NCT06951451 · MoH/CSR/22/26909

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗