Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05680207
• Other study ID #: DM Training
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: January 2023
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the effect of nurse-led empowerment training given to patients with Type 2 Diabetes on clinical findings and empowerment behaviors will be investigated.

Description:

The research is a randomized controlled design research that includes a pre-test/post-test design. The primary outcome expected in the research; change in empowerment behaviors as a result of the training given; secondary outcomes are changes in clinical findings.

The research universe; All Type 2 diabetes patients who applied to the endocrinology polyclinic of a private hospital in Eskisehir city center between March-July 2019 consisted of. In the study, the sample was randomly selected, and it was aimed to reach all patients with Type 2 diabetes who were 18 years of age and older, with a diagnosis period of one year or more.

In the study, patients were randomly assigned to the intervention group, which included 6 weeks of training, or to the control group, which was on a 6-week waiting list. It used a question-based format to address the educational, behavioral, and psychosocial needs of patients within the scope of a 12-hour empowerment program that lasted for 6 weeks, 2 hours a week.

Education (DSMS (Developing Empowerment-Based Diabetes Self-Management Support)) is planned as stated literature.

Purpose of education: Empowerment as a philosophy of care emphasizes a collaborative approach to facilitating behavior change for patients themselves. Empowerment approach; Goal setting is a five-step process that provides patients with the knowledge and clarity they need to develop and achieve their diabetes and lifestyle goals. The first two steps are to identify the problem and identify patients' beliefs, thoughts, and feelings that may support or hinder their efforts. The third step is to determine the long-term goals expected from patients. In this step, patients are then expected to make a behavioral change that will help them achieve their long-term goals. The last step is for patients to evaluate their efforts and determine what they have learned in the process. Empowerment training was determined within the framework of this process.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago

Exclusion Criteria:

• Mental retardation

• Dementia

• Deafness

• Blindness

• Psychiatric illness

• Steroid use

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Empowerment
• Patient Empowerment

Intervention

Behavioral:
• Diabetes self- management education (DSME) program
We offered a two-hour course each week, comprising of two sessions of lectures (40 minutes each), two breaks (10 min each) and interactive session (20 min). In the interactive session, patients could communicate with each other in groups or raise any questions to the investigators.

Locations

Country	Name	City	State
Turkey	Acibadem Hospital	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Messina R, Rucci P, Sturt J, Mancini T, Fantini MP. Assessing self-efficacy in type 2 diabetes management: validation of the Italian version of the Diabetes Management Self-Efficacy Scale (IT-DMSES). Health Qual Life Outcomes. 2018 Apr 23;16(1):71. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in The Diabetes Empowerment Scale scores	The Diabetes Empowerment Scale (DES-28) questionnaires consist of 28 items with 3 subscales, with each item rated along a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The range of score was divided in three subgroups as low (28-65 scores), middle (66-103) and high (104-140).; All items have been scored so that a higher value indicates stronger empowerment.	3 months
Secondary	improvement in HbA1c levels	decrease in HbA1c (mmol/mol)	6 months
Secondary	improvement in fasting glucose	decrease in fasting glucose (mmol/L)	6 months
Secondary	improvement in low density lipoprotein	decrease in low density lipoprotein (mmol/L)	6 months
Secondary	improvement in triglyceride	decrease in triglyceride (mmol/L)	6 months