Ischemic Cardiovascular DiseaseNCT06951451
Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman
A study testing smartphone application (MED-AD) and Short Text-message Reminders in people with Ischemic Cardiovascular Disease and Hypertension, run by Sultan Qaboos University at 1 site in Oman.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Cardiovascular Disease, Hypertension, Hyperlipidemia
- What is being tested?
- smartphone application (MED-AD) and Short Text-message Reminders
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteOman
- Study dates
- 1 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman: A Multicenter Randomized Clinical Trial
This study aims to:
- 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.
- 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.
Read more
This study is a prospective randomized controlled clinical trial (RCT) with three arms:
- 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
- Text message reminders: Participants will receive short text message (SMS) reminders to remind them to take medications as prescribed once daily
- Routine care only: Participants will receive routine care that does not include text messages or reminders and education through an application.
- Being tested
- smartphone application (MED-AD), Short Text-message Reminders
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smartphone application (MED-AD)Behavioural
- 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.
- Medication Adherence Report: The application will generate a weekly report on medication
Short Text-message RemindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MED-AD application | Experimental | 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. Receives: Behavioral: smartphone application (MED-AD) |
| Short Text-message Reminders | Active comparator | 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. Receives: Behavioral: Short Text-message Reminders |
| Routine care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to Refills and Medications Scale
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.
Measured: BASELINE, AT 6 MONTHS, AT 12 MONTHS
The Proportion of Days Covered
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.
Measured: BASELINE, AT 6 MONTHS, AT 12 MONTHS
Secondary outcomes (1)
Clinical outcomes
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])
Measured: BASELINE, AT 6 MONTHS, AT 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jun 2025
- Primary completion28 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Huda Al Noumani, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951451
- Sponsor's protocol ID
- MoH/CSR/22/26909
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06951451
- Acronym / sponsor ID
- MoH/CSR/22/26909
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to:
- 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.
- 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:
- 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
- Text message reminders: Participants will receive short text message (SMS) reminders to remind them to take medications as prescribed once daily
- Routine care only: Participants will receive routine care that does not include text messages or reminders and education through an application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MED-AD application | Experimental | Behavioral: smartphone application (MED-AD)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. |
| Short Text-message Reminders | Active comparator | Behavioral: Short Text-message RemindersParticipants 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. |
| Routine care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | MED-AD application |
| Short Text-message RemindersParticipants 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. | Behavioural | Short Text-message Reminders |
Primary outcome
Adherence to Refills and Medications Scale
Time frame: 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
Time frame: 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.
1 secondary outcome
Clinical outcomes
Time frame: BASELINE, AT 6 MONTHS, AT 12 MONTHS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smartphone application (MED-AD) and Short Text-message Reminders in people with Ischemic Cardiovascular Disease and Hypertension, run by Sultan Qaboos University at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to Refills and Medications Scale (time frame: BASELINE, AT 6 MONTHS, AT 12 MONTHS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.