Effectiveness of Telehealth Program in Patients With Type 2 Diabetes

June 13, 2023 updated by: Fatih Ozden, Muğla Sıtkı Koçman University

Effectiveness of Telehealth Program in Patients With Type 2 Diabetes: Randomized Controlled Study

Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of telehealth technologies in the field of health is becoming more and more widespread. Telehealth has become one of the frequently used options in the follow-up process of chronic diseases such as diabetes, especially in recent years. Diabetes education is of great importance in the effective management of diabetes. Studies have shown that patients given diabetes education have positive developments in their ability to manage the disease and their attitudes towards the disease. The aim of the study is to compare the education given to individuals with Type 2 diabetes via mobile phone and the education given to individuals via brochures with conventional methods.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Turkey
      • Muğla, Turkey, 48000
        • Muğla Training and Research Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having a diagnosis of type 2 diabetes mellitus for at least 6 months,
  • Those between the ages of 18-65,
  • Receiving oral antidiabetic and/or insulin therapy,
  • Having a mobile phone capable of receiving and playing video messages,
  • Does not have hearing, speech and psychiatric problems that prevent communication,

Exclusion Criteria:

  • Individuals who do not volunteered to participate in the study
  • Patients who have hearing, speech and psychiatric problems that prevent communication

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehealth Education (TE)
After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.
Other: TE
After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.
Active Comparator: Conventional Education (CE)
Paper-based education forms will be given to the patients in the first group. Face-to-face conventional diabetes education will be carried out.
Other: CE
After the first meeting, diabetes education videos prepared in two parts a week will be sent to the mobile phones of the individuals. The video submission will be completed in a total of four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Survey of Physical Activity (IPAQ)
Time Frame: 4 weeks
Physical activity assessment
4 weeks
Goal orientation in exercise measure (GOEM)
Time Frame: 4 weeks
Measurement of goal orientation in exercise
4 weeks
Mini Nutritional Assessment
Time Frame: 4 weeks
To evaluate the nutrition status of the patients
4 weeks
The Problem Areas in Diabetes Scale (PADS)
Time Frame: 4 weeks
PADS evaluates comprehensive diabetes evaluation. A total score is ranged between 0 - 100. Patients scoring 40 or higher may be at the level of "emotional burnout" and warrant special attention.
4 weeks

Collaborators and Investigators

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

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Study Chair: Serap Tuna, PhD, Muğla Sıtkı Koçman University
  • Principal Investigator: Emine Neşe Yeniçeri, MD, Muğla Sıtkı Koçman University
  • Principal Investigator: Cem Şahin, MD, Muğla Sıtkı Koçman 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)

January 6, 2022

Primary Completion (Actual)

May 10, 2023

Study Completion (Actual)

May 15, 2023

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mugla Sıtkı Kocman

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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