Telehealth , Lipid Lowering Medication AdherenceNCT05872919
Telenhealth and Adherence to Stains
A study testing SMS reminder massages about adherence in people with Telehealth , Lipid Lowering Medication Adherence, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the effect of telehealth through short messaging services (SMSs) on adherence to statins in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Telehealth , Lipid Lowering Medication Adherence
- What is being tested?
- SMS reminder massages about adherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years)
- Both sexes
- Type 1 and 2 diabetes
- Had a prescription of lipid lowering medication with a minimum duration of two weeks
- Have an active contact phone number that can receive text messages
- Able to read SMS text messages (patient, or family member)
Who cannot join
- Communication impairment
- Taking any psychotropic medications
- Familial hypercholesterolemia
- Already established coronary heart disease
- not on lipid lowering medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telehealth and Challenges in Statin Adherence in Patients With Diabetes: A Randomized Controlled Trial
To evaluate the effect of telehealth through short messaging services (SMSs) on adherence to statins in patients with diabetes.
- Being tested
- SMS reminder massages about adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS reminder massages about adherenceOther
SMS three-times per week in the first six weeks and twice per week in the second six weeks reminding the patient about adherence to prescribed medication
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | will not receive the intervention |
| Study group | Experimental | will receive the intervention Receives: Other: SMS reminder massages about adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate
Adherence rate was measured by:
- Pill counting (PC) Pill count (PC) Is an objective mesearrment, calculated by the sum of days covered by lipid-lowering medication divided by the number of days in that period.
Investigators calculated the index date for adherence on the day of recruitment for each patient.
Patients were considered to have good adherence to lipid-lowering medication if their estimated PC was ≥80%,
Equation : Sum of days covered by lipid-lowering medication / number of days in that period × 100.
Percentage ≧ 80% means a good medication adherence
Percentage < 80% means a poor medication adherence
Measured: 6 and 12 weeks
Adherence rate
Medication Adherence Reporting Scale -5 (MARS-5) is a self-reporting scale. Is a subjective method of mesearrment, It is a 5 five-point Likert scale response ranging from 1 (always) to 5 (never).
The total score of the MARS-5 ranges from 5 to 25
Mean score ≥20 means good medication adherence
Mean score < 20 means poor medication adherence
Measured: 6 and 12 weeks
Secondary outcomes (3)
Lipid profile
Mean score of lipid profile will be monitored at follow up times comparison between baseline and follow up measurements will be done
Measured: at 12 week
Acute cardiovascular events (CVE)
Number of cases who will be hospitalized or exposed to acute cardiovascular events (CVD) within follow periods.
Measured: at 12 weeks
Mortality
Number of death or mortality within follow up period.
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start15 Jul 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telehealth , Lipid Lowering Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be offered to participate. Willing patients will be randomly assigned to one of two groups: Two arms study design: first arm (control group)won't receive intervention while the second arm (intervention group) will receive telenursing intervention through SMS; Is a text messages will be sent to the intervention group comprised of a reminder on when, how to take lipid lowering medication, benefits, and adverse effect of not taken the drug as prescribed for three months duration. SMS (Short Messaging Service) will be sent three times per week in the first six weeks and twice per week in the second six weeks.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amna A. Desouky, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872919
- Sponsor's protocol ID
- Adherence for medication
- Status last verified
- Dec 2024
- First submitted
- 15 May 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth and Challenges in Statin Adherence in Patients With Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05872919
- Acronym / sponsor ID
- Adherence for medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 24 May 2023 (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.
To evaluate the effect of telehealth through short messaging services (SMSs) on adherence to statins in patients with diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be offered to participate. Willing patients will be randomly assigned to one of two groups: Two arms study design: first arm (control group)won't receive intervention while the second arm (intervention group) will receive telenursing intervention through SMS; Is a text messages will be sent to the intervention group comprised of a reminder on when, how to take lipid lowering medication, benefits, and adverse effect of not taken the drug as prescribed for three months duration. SMS (Short Messaging Service) will be sent three times per week in the first six weeks and twice per week in the second six weeks.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –will not receive the intervention |
| Study group | Experimental | Other: SMS reminder massages about adherencewill receive the intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult (≥18 years)
- Both sexes
- Type 1 and 2 diabetes
- Had a prescription of lipid lowering medication with a minimum duration of two weeks
- Have an active contact phone number that can receive text messages
Key exclusion criteria (5 listed)
- Communication impairment
- Taking any psychotropic medications
- Familial hypercholesterolemia
- Already established coronary heart disease
- not on lipid lowering medication
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 |
|---|---|---|
| SMS reminder massages about adherenceSMS three-times per week in the first six weeks and twice per week in the second six weeks reminding the patient about adherence to prescribed medication | Other | Study group |
Primary outcome
Adherence rate
Time frame: 6 and 12 weeks
Adherence rate was measured by: 1. Pill counting (PC) Pill count (PC) Is an objective mesearrment, calculated by the sum of days covered by lipid-lowering medication divided by the number of days in that period. Investigators calculated the index date for adherence on the day of recruitment for each patient. Patients were considered to have good adherence to lipid-lowering medication if their estimated PC was ≥80%, Equation : Sum of days covered by lipid-lowering medication / number of days in that period × 100. Percentage ≧ 80% means a good medication adherence Percentage < 80% means a poor medication adherence
Adherence rate
Time frame: 6 and 12 weeks
Medication Adherence Reporting Scale -5 (MARS-5) is a self-reporting scale. Is a subjective method of mesearrment, It is a 5 five-point Likert scale response ranging from 1 (always) to 5 (never). The total score of the MARS-5 ranges from 5 to 25 Mean score ≥20 means good medication adherence Mean score < 20 means poor medication adherence
3 secondary outcomes
Lipid profile
Time frame: at 12 week
Acute cardiovascular events (CVE)
Time frame: at 12 weeks
Mortality
Time frame: at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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. This study is not recruiting at the moment.
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 SMS reminder massages about adherence in people with Telehealth , Lipid Lowering Medication Adherence, run by Assiut University at 1 site in Egypt.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 27 Dec 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 rate (time frame: 6 and 12 weeks). 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 27 Dec 2024.