New Diagnosed Type 2 Diabetes - Online Education

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Online Education; Other: Control Group

• Registration Number: NCT05341063
• Lead Sponsor: Mehmet Akif Ersoy University

Brief Summary

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.

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 Timeline

• Study Start: 2021-10-10
• Primary Completion: 2021-11-10
• Status Verified: 2022-04
• Study Completion: 2022-04-01
• Study First Submitted: 2022-04-14
• Study First Submitted QC: 2022-04-21
• Last Update Submitted: 2022-04-21
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Online Education	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.
Control Group	Control Group	The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

Primary Outcome Measures

Name	Time	Method
The Diabetes Self-Care Activities Questionnaire	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.
Health Literacy Scale	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.

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey