New Diagnosed Type 2 Diabetes - Online Education

NCT ID: NCT05341063

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2022-04-01

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Online Education

Intervention Type: BEHAVIORAL

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.

Control Group

The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

Group Type: EXPERIMENTAL

Control Group

Intervention Type: OTHER

The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

Interventions

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.

Intervention Type: BEHAVIORAL

Control Group

The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Nurten Terkes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Aydemir, Dr

Role: STUDY_CHAIR

Akdeniz University Hospital

Locations

Akdeniz University

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Agarwal P, Mukerji G, Desveaux L, Ivers NM, Bhattacharyya O, Hensel JM, Shaw J, Bouck Z, Jamieson T, Onabajo N, Cooper M, Marani H, Jeffs L, Bhatia RS. Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 10;7(1):e10321. doi: 10.2196/10321.

Reference Type: RESULT

PMID: 30632972 (View on PubMed)

Park J, Kim SH, Kim JG. Effects of message framing and health literacy on intention to perform diabetes self-care: A randomized controlled trial. Diabetes Res Clin Pract. 2020 Mar;161:108043. doi: 10.1016/j.diabres.2020.108043. Epub 2020 Jan 30.

Reference Type: RESULT

PMID: 32006642 (View on PubMed)

Other Identifiers

GO 2021/294

Identifier Type: -

Identifier Source: org_study_id