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

Primary Purpose

Diabetes Mellitus, Type 2, Empowerment, Patient Empowerment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Diabetes self- management education (DSME) program
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2

Eligibility Criteria

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

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

Sites / Locations

  • Acıbadem Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Type 2 Diabetes Mellitus patients who received a empowerment training program for 6 weeks, 2 hours a week

Type 2 Diabetes Mellitus patients who did not receive a empowerment training program

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

improvement in HbA1c levels
decrease in HbA1c (mmol/mol)
improvement in fasting glucose
decrease in fasting glucose (mmol/L)
improvement in low density lipoprotein
decrease in low density lipoprotein (mmol/L)
improvement in triglyceride
decrease in triglyceride (mmol/L)

Full Information

First Posted
December 20, 2022
Last Updated
January 8, 2023
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05680207
Brief Title
Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings
Official Title
The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences 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
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.
Detailed 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Type 2 Diabetes Mellitus patients who received a empowerment training program for 6 weeks, 2 hours a week
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Type 2 Diabetes Mellitus patients who did not receive a empowerment training program
Intervention Type
Behavioral
Intervention Name(s)
Diabetes self- management education (DSME) program
Intervention Description
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.
Primary Outcome Measure Information:
Title
improvement in The Diabetes Empowerment Scale scores
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
improvement in HbA1c levels
Description
decrease in HbA1c (mmol/mol)
Time Frame
6 months
Title
improvement in fasting glucose
Description
decrease in fasting glucose (mmol/L)
Time Frame
6 months
Title
improvement in low density lipoprotein
Description
decrease in low density lipoprotein (mmol/L)
Time Frame
6 months
Title
improvement in triglyceride
Description
decrease in triglyceride (mmol/L)
Time Frame
6 months

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: Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago Exclusion Criteria: Mental retardation Dementia Deafness Blindness Psychiatric illness Steroid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
müzelfe bıyık, Ms
Organizational Affiliation
Eskişehir Osmangazi University
Official's Role
Study Chair
Facility Information:
Facility Name
Acıbadem Hospital
City
Eskişehir
ZIP/Postal Code
26170
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29685153
Citation
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: 10.1186/s12955-018-0901-3.
Results Reference
result

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

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