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The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes

Primary Purpose

Diabete Type 2

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Application of The Theory of Planned Behaviour for Diabetes
Sponsored by
Sakarya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabete Type 2 focused on measuring Diabetes, Theory Of Planned Behavior, Patient Empowerment, Self-Efficacy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Volunteering to participate in the study 40 years and older Diagnosed with type 2 DM at least 1 year ago Treated at the hospital where the study will be conducted Using antidiabetic agents No communication problem Contactable by phone Exclusion Criteria: Those who do not meet the inclusion criteria for the study Participants who did not give consent at any stage of the study and left

Sites / Locations

  • Sakarya UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Patient Empowerment Scale
The scale consists of 37 items in total. Scale is graded in a 5-point Likert type, and in total, the lowest 37 and the highest 185 points are taken. There is an opposite item in the scale. This applied to individuals over the age of 18 who receive long-term care services.
Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
The scale consists of 20 items in total. The scale is scored as a Likert type (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always), and the lowest score from the scale is 20 and the highest score is 100.

Secondary Outcome Measures

Blood Glucose Level
A condition in which the blood glucose level is above normal. Hyperglycemia is mentioned when fasting blood glucose exceeds 100 mg/dl and postprandial blood glucose exceeds 140 mg/dl.

Full Information

First Posted
June 6, 2023
Last Updated
July 17, 2023
Sponsor
Sakarya University
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1. Study Identification

Unique Protocol Identification Number
NCT05904847
Brief Title
The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes
Official Title
The Effect of Education Given to Diabetes Patients According to the Planned Behavior Theory on Patient Empowerment and Self-Efficacy: A Single-Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
July 17, 2023 (Anticipated)
Study Completion Date
October 9, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sakarya University

4. Oversight

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

5. Study Description

Brief Summary
It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabete Type 2
Keywords
Diabetes, Theory Of Planned Behavior, Patient Empowerment, Self-Efficacy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Application of The Theory of Planned Behaviour for Diabetes
Intervention Description
In the study, diabetes education consisting of a total of 4 sessions structured according to the Planned Behavior Theory will be applied to the intervention group, and a standard diabetes education consisting of a single session containing information about diabetes on the website of the Ministry of Health will be applied to the control group. The training will be given face-to-face in groups of 10-15 people. After the training, the participants will be monitored for 3 months. To increase patient empowerment and self-efficacy, the intervention group will be followed up by phone calls every 15 days to increase motivation and answer questions.
Primary Outcome Measure Information:
Title
Patient Empowerment Scale
Description
The scale consists of 37 items in total. Scale is graded in a 5-point Likert type, and in total, the lowest 37 and the highest 185 points are taken. There is an opposite item in the scale. This applied to individuals over the age of 18 who receive long-term care services.
Time Frame
2 weeks
Title
Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes
Description
The scale consists of 20 items in total. The scale is scored as a Likert type (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always), and the lowest score from the scale is 20 and the highest score is 100.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Blood Glucose Level
Description
A condition in which the blood glucose level is above normal. Hyperglycemia is mentioned when fasting blood glucose exceeds 100 mg/dl and postprandial blood glucose exceeds 140 mg/dl.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteering to participate in the study 40 years and older Diagnosed with type 2 DM at least 1 year ago Treated at the hospital where the study will be conducted Using antidiabetic agents No communication problem Contactable by phone Exclusion Criteria: Those who do not meet the inclusion criteria for the study Participants who did not give consent at any stage of the study and left
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
seda goger
Phone
009005070275712
Email
f.sedaucar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
dilek cingil
Phone
009005058177683
Email
ddayanircingil@gmail.com
Facility Information:
Facility Name
Sakarya University
City
Sakarya
State/Province
Serdivan
ZIP/Postal Code
54000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burçin Çakır
Email
burcincakir@sakarya.edu.tr

12. IPD Sharing Statement

Learn more about this trial

The Effect of Theory-Based Education on Patient Empowerment and Self-Efficacy in Patients With Type 2 Diabetes

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