New Diagnosed Type 2 Diabetes - Online Education

April 21, 2022 updated by: Nurten Terkes, Mehmet Akif Ersoy University

The Effect of OnlineEducation Given to Individuals With Newly Diagnosed Type 2 Diabetes on Metabolic Control, Self-Care and Health Literacy

To determine the effect of online education given to individuals with newly diagnosed type 2 diabetes on metabolic control, self-care and health literacy. A randomized controlled trial. This study was conducted with 95 new diagnosed diabetes patients in the Endocrine Polyclinic of a university hospital. Personal Information Form, Diabetes Self-Care Activities Scale and Health Literacy Scale were used to evaluate the data. SPSS 21 program was used in the analysis of the data and a p<0.05 level was considered significant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants were randomized into both groups (intervention and control). The Consolidated Standard of Reporting Trials-CONSORT 2010-guidelines were used to conduct a randomized controlled trial. Sample size was estimated using the G*POWER software tool, based on 80% power and 95% confidence interval. A minimum of 45 individuals in each group were needed to determine the difference in the mean of the measurements (10% more calculated for the probability of sample loss). Between the data collection dates, 248 patients were reached and invited to participate in this study. 78 patients did not meet the inclusion criteria and 70 patients refused to participate. A total of 100 eligible patients were randomized; 50 were assigned to the intervention group and 50 to the control group. After reaching the targeted number, data collection forms were filled in. The participants were then randomly randomized into control and intervention groups in the computer program. Until the randomization was made, it was not known in which groups the individuals were. Randomization was performed after the target number was reached. The first diabetes self-management training was given to all patients by diabetes education nurses face-to-face in the outpatient clinic.

After the study objectives were stated and informed consent was obtained from the study participants, face-to-face interviews by trained interviewers were used to complete the questionnaires. The interviews lasted 20-25 minutes.

Study Type

Interventional

Enrollment (Actual)

97

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
      • Antalya, Turkey
        • Akdeniz University

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having a diagnosis of Type 2 diabetes mellitus for at most one year
  • Be between the ages of 18-65
  • Being on oral antidiabetic and/or insulin therapy
  • Have a smart phone
  • Volunteer to participate in the study
  • Hearing that interferes with communication
  • Sensory loss such as speech
  • Psychiatric problem

Exclusion Criteria:

  • Illiterate
  • Have a physical, cognitive or mental disability to answer questions
  • Individuals with type 2 DM who did not volunteer to participate in the study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Following the first meeting after the pre-tests, a weekly training was created via Zoom. Diabetes education presentations prepared beforehand were explained in two parts in each training. Training interventions were carried out weekly over Zoom for 4 weeks, lasting approximately 40 minutes. Patients' questions were answered.
Behavioral: Online Education

Diabetes education presentations prepared beforehand were explained in two parts in each training. Training interventions were carried out weekly over Zoom for 4 weeks, lasting approximately 40 minutes. Patients' questions were answered.

Two months after the training was completed, the current routine analysis results of the participants were taken again, and height and weight measurements were made with the same measurement tools. Participants were allowed to fill in the data collection forms again.
Experimental: Control Group
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Other: Control Group
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Diabetes Self-Care Activities Questionnaire
Time Frame: 5 minute
The Diabetes Self-Care Activities Questionnaire was developed by Toobert and Glasgow to determine the self-care activities of individuals with diabetes. The Turkish validity and reliability of the questionnaire were conducted by Kav et al. (2010) and the total Cronbach alpha value was found 0.72. The tool contains 11 items, which measure the frequency of performing dia- betes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The scale total score ranges between 0-7. Higher scores indicate more self-care activities.
5 minute
Health Literacy Scale
Time Frame: 5 minute
It is a 4-point Likert type scale consisting of 14 items and three parts, developed by Ishikawa et al. (2008). The scale was developed to measure the functional, interactive and critical health literacy of individuals with chronic diseases.
5 minute

Collaborators and Investigators

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

Sponsor

Mehmet Akif Ersoy University

Investigators

  • Study Chair: Mustafa Aydemir, Dr, Akdeniz University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 10, 2021

Primary Completion (Actual)

November 10, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

April 14, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 2021/294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

All authors contributed to the interpretation, writing, and approval of the final manuscript.

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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