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New Diagnosed Type 2 Diabetes - Online Education

M

Mehmet Akif Ersoy University

Status

Completed

Conditions

Type 2 Diabetes

Treatments

Behavioral: Online Education
Other: Control Group

Study type

Interventional

Funder types

Other

Identifiers

NCT05341063
GO 2021/294

Details and patient eligibility

About

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.

Full 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.

Enrollment

97 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

97 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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