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

NCT ID: NCT05680207

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2019-08-30

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.

Conditions

Diabetes Mellitus, Type 2; Empowerment; Patient Empowerment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: ACTIVE_COMPARATOR

Diabetes self- management education (DSME) program

Intervention Type: BEHAVIORAL

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.

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kutahya Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Muzelfe BIYIK

Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

müzelfe bıyık, Ms

Role: STUDY_CHAIR

Eskişehir Osmangazi University

Locations

Acıbadem Hospital

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 29685153 (View on PubMed)

Other Identifiers

DM Training

Identifier Type: -

Identifier Source: org_study_id