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

Diabete Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904847
• Other study ID #: 13353
• Status: Completed
• Phase: N/A
• Start date: April 16, 2023
• Est. completion date: October 26, 2023

Study information

• Verified date: May 2024
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 26, 2023
• Est. primary completion date: June 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Application of The Theory of Planned Behaviour for Diabetes
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.

Locations

Country	Name	City	State
Turkey	Sakarya University	Sakarya	Serdivan

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Primary	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.	2 weeks
Secondary	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.	3 months