Telenhealth and Adherence to Stains

December 21, 2024 updated by: Amna A. Desouky, MD, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
will not receive the intervention
Experimental: Study group
will receive the intervention
Other: SMS 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 and 12 weeks
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
6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipid profile
Time Frame: at 12 week
Mean score of lipid profile will be monitored at follow up times comparison between baseline and follow up measurements will be done
at 12 week
Acute cardiovascular events (CVE)
Time Frame: at 12 weeks
Number of cases who will be hospitalized or exposed to acute cardiovascular events (CVD) within follow periods.
at 12 weeks
Mortality
Time Frame: at 12 weeks
Number of death or mortality within follow up period.
at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 21, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Adherence for medication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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