NCT05904847

Brief Summary

It is essential to manage the disease to prevent and reduce complications and mortality in patients with diabetes. Adequate information and options should be provided to patients by healthcare providers so that patients can make informed choices. Patient education is a patient empowerment process designed to enable patients to be responsible for their health. With this study, it is considered essential to educate diabetic patients according to the theory of planned behavior and to develop self-efficacy by contributing to patient empowerment in this way.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

April 16, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2023

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

June 6, 2023

Last Update Submit

May 6, 2024

Conditions

Diabete Type 2

Keywords

DiabetesTheory Of Planned BehaviorPatient EmpowermentSelf-Efficacy

Outcome Measures

Primary Outcomes (2)

  • Patient Empowerment Scale

    The scale consists of 37 items in total. Scale is graded in a 5-point Likert type, and in total, the lowest 37 and the highest 185 points are taken. There is an opposite item in the scale. This applied to individuals over the age of 18 who receive long-term care services.

    2 weeks

  • Diabetes Management Self-Efficacy Scale for Patients with Type 2 Diabetes

    The scale consists of 20 items in total. The scale is scored as a Likert type (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always), and the lowest score from the scale is 20 and the highest score is 100.

    2 weeks

Secondary Outcomes (1)

  • Blood Glucose Level

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Application of The Theory of Planned Behaviour for Diabetes

Control

NO INTERVENTION

Interventions

Application of The Theory of Planned Behaviour for DiabetesBEHAVIORAL

In the study, diabetes education consisting of a total of 4 sessions structured according to the Planned Behavior Theory will be applied to the intervention group, and a standard diabetes education consisting of a single session containing information about diabetes on the website of the Ministry of Health will be applied to the control group. The training will be given face-to-face in groups of 10-15 people. After the training, the participants will be monitored for 3 months. To increase patient empowerment and self-efficacy, the intervention group will be followed up by phone calls every 15 days to increase motivation and answer questions.

Intervention

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study
  • years and older
  • Diagnosed with type 2 DM at least 1 year ago
  • Treated at the hospital where the study will be conducted
  • Using antidiabetic agents
  • No communication problem
  • Contactable by phone

You may not qualify if:

  • Participants who did not give consent at any stage of the study and left

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54000, Turkey (Türkiye)

Location

Related Publications (1)

  • Goger S, Sener S, Ci Ngi L D. The effect of training to diabetes patients according to planned behavior theory on self-efficacy and patient empowerment: A randomized study. Prim Care Diabetes. 2024 Oct;18(5):486-492. doi: 10.1016/j.pcd.2024.08.002. Epub 2024 Aug 24.

    PMID: 39183095DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusPatient Participation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

April 16, 2023

Primary Completion

June 17, 2023

Study Completion

October 26, 2023

Last Updated

May 7, 2024

Record last verified: 2024-05

Locations

TU(1)