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Telenhealth and Adherence to Stains

Telehealth and Challenges in Statin Adherence in Patients With Diabetes: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05872919
Enrollment
90
Registered
2023-05-24
Start date
2023-07-15
Completion date
2024-01-30
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telehealth , Lipid Lowering Medication Adherence

Brief summary

To evaluate the effect of telehealth through short messaging services (SMSs) on adherence to statins in patients with diabetes.

Interventions

OTHERSMS reminder massages about adherence

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

MA will provide randomization AD will assess participant at baseline and follow-up EH will deliver the intervention.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* Communication impairment * Taking any psychotropic medications * Familial hypercholesterolemia * Already established coronary heart disease * not on lipid lowering medication

Design outcomes

Primary

MeasureTime frameDescription
Adherence rate6 and 12 weeksAdherence 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

Secondary

MeasureTime frameDescription
Lipid profileat 12 weekMean score of lipid profile will be monitored at follow up times comparison between baseline and follow up measurements will be done
Acute cardiovascular events (CVE)at 12 weeksNumber of cases who will be hospitalized or exposed to acute cardiovascular events (CVD) within follow periods.
Mortalityat 12 weeksNumber of death or mortality within follow up period.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026