Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings
The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial
1 other identifier
interventional
216
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2019
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2019
CompletedFirst Submitted
Initial submission to the registry
December 20, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedJanuary 11, 2023
January 1, 2023
5 months
December 20, 2022
January 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
improvement in HbA1c levels
6 months
improvement in fasting glucose
6 months
improvement in low density lipoprotein
6 months
improvement in triglyceride
6 months
Study Arms (2)
Intervention group
ACTIVE COMPARATORType 2 Diabetes Mellitus patients who received a empowerment training program for 6 weeks, 2 hours a week
Control group
NO INTERVENTIONType 2 Diabetes Mellitus patients who did not receive a empowerment training program
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago
You may not qualify if:
- Mental retardation
- Dementia
- Deafness
- Blindness
- Psychiatric illness
- Steroid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Acıbadem Hospital
Eskişehir, 26170, Turkey (Türkiye)
Related 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: 10.1186/s12955-018-0901-3.
PMID: 29685153RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
müzelfe bıyık, Ms
Eskişehir Osmangazi University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of Science
Study Record Dates
First Submitted
December 20, 2022
First Posted
January 11, 2023
Study Start
March 1, 2019
Primary Completion
July 30, 2019
Study Completion
August 30, 2019
Last Updated
January 11, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share