Clinical trial NCT05680207: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Empowerment
Patient Empowerment
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: improvement in The Diabetes Empowerment Scale scores
timeFrame: 3 months
Secondary outcomes:
measure: improvement in HbA1c levels
timeFrame: 6 months
measure: improvement in fasting glucose
timeFrame: 6 months
measure: improvement in low density lipoprotein
timeFrame: 6 months
measure: improvement in triglyceride
timeFrame: 6 months
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Acıbadem Hospital
Study officials:
affiliation: Eskişehir Osmangazi University
name: müzelfe bıyık, Ms
role: STUDY_CHAIR
References:
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.