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New Diagnosed Type 2 Diabetes - Online Education

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Online Education
Control Group
Sponsored by
Mehmet Akif Ersoy University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm 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.

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

Outcomes

Primary Outcome Measures

The Diabetes Self-Care Activities Questionnaire
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
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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2022
Last Updated
April 21, 2022
Sponsor
Mehmet Akif Ersoy University
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1. Study Identification

Unique Protocol Identification Number
NCT05341063
Brief Title
New Diagnosed Type 2 Diabetes - Online Education
Official Title
The Effect of OnlineEducation Given to Individuals With Newly Diagnosed Type 2 Diabetes on Metabolic Control, Self-Care and Health Literacy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mehmet Akif Ersoy University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
They did not know if they were in the control and intervention group at the time of randomization.
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Online Education
Intervention Description
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
Other
Intervention Name(s)
Control Group
Intervention Description
The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
Primary Outcome Measure Information:
Title
The Diabetes Self-Care Activities Questionnaire
Description
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.
Time Frame
5 minute
Title
Health Literacy Scale
Description
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.
Time Frame
5 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Aydemir, Dr
Organizational Affiliation
Akdeniz University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All authors contributed to the interpretation, writing, and approval of the final manuscript.
Citations:
PubMed Identifier
30632972
Citation
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.
Results Reference
result
PubMed Identifier
32006642
Citation
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.
Results Reference
result

Learn more about this trial

New Diagnosed Type 2 Diabetes - Online Education

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