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

Sponsor
Kutahya Health Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT05680207
Collaborator
(none)
216
1
2
6
36.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diabetes self- management education (DSME) program
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Jul 30, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intervention group

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

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.

No Intervention: Control group

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

Outcome Measures

Primary Outcome Measures

  1. improvement in The Diabetes Empowerment Scale scores [3 months]

    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

  1. improvement in HbA1c levels [6 months]

    decrease in HbA1c (mmol/mol)

  2. improvement in fasting glucose [6 months]

    decrease in fasting glucose (mmol/L)

  3. improvement in low density lipoprotein [6 months]

    decrease in low density lipoprotein (mmol/L)

  4. improvement in triglyceride [6 months]

    decrease in triglyceride (mmol/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acıbadem Hospital Eskişehir Turkey 26170

Sponsors and Collaborators

  • Kutahya Health Sciences University

Investigators

  • Study Chair: müzelfe bıyık, Ms, Eskişehir Osmangazi University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muzelfe BIYIK, Master of Science, Kutahya Health Sciences University
ClinicalTrials.gov Identifier:
NCT05680207
Other Study ID Numbers:
  • DM Training
First Posted:
Jan 11, 2023
Last Update Posted:
Jan 11, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2023