NCT05680207

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

December 20, 2022

Last Update Submit

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 COMPARATOR

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

Control group

NO INTERVENTION

Type 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.

Intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2EmpowermentPatient Participation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • müzelfe bıyık, Ms

    Eskişehir Osmangazi University

    STUDY CHAIR

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

Locations