NCT06768645

Brief Summary

This study aimed to evaluate the impact of diabetic foot care training delivered using the Pecha Kucha (20\*20) presentation method on the knowledge, self-efficacy, and behavior levels of patients with Type 2 diabetes. Conducted between December 10, 2023, and October 7, 2024, this randomized controlled experimental study included 125 diabetic individuals, with 62 in the experimental group and 63 in the control group. The experimental group received diabetic foot care education using the Pecha Kucha method, while the control group received conventional education. Data were collected using the Patient Assessment Form, Diabetes Foot Knowledge Questionnaire, Diabetic Foot Care Self-Efficacy Scale, and Foot Self-Care Behavior Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

December 29, 2024

Last Update Submit

January 8, 2025

Conditions

Keywords

Pecha KuchaType 2 diabetesDiabetic FootPatient Education

Outcome Measures

Primary Outcomes (3)

  • Diabetes Foot Knowledge Questionnaire

    Diabetes Foot Knowledge Questionnaire min:0 max: 5 , Above average placement

    up to 24 weeks

  • Diabetic Foot Care Self-Efficacy Scale

    Diabetic Foot Care Self-Efficacy Scale min:0 max:100 , scores above the 50 points

    up to 24 weeks

  • Foot Self-Care Behavior Scale

    Foot Self-Care Behavior Scale min: 10 max :86, scores above the 48 point

    up to 24 weeks

Study Arms (2)

Pecha Kucha

EXPERIMENTAL

Given Pecha Kucha education

Behavioral: Diabetic foot care education delivered using the Pecha Kucha method

Control

ACTIVE COMPARATOR

normal education

Behavioral: traditional diabetic foot care education

Interventions

The study commenced after obtaining ethical approval and written consent from the relevant institution. The Pecha Kucha presentation was prepared by the researcher, adhering to established literature and the specific requirements of the technique. The education covered six key topics: 1) Diabetes and Foot Problems, 2) Daily Foot Care, 3) Appropriate Socks, 4) Appropriate Footwear, 5) Nail Care, and 6) Daily Life Precautions. Expert opinions were sought from four academics (S.Ö; K.L; Z.Z; G.F) with expertise in the field to establish content validity for the final version of the Pecha Kucha diabetic foot care presentation. Following expert approval, a pilot study was conducted with 10 diabetic patients who met the sample group criteria. Feedback from these patients regarding system functionality, clarity, and flow was incorporated to finalize the presentation. Afterward, the finalized "Pecha Kucha Information" training was delivered to the experimental group. The presentations were cond

Pecha Kucha

traditional diabetic foot care education

Control

Eligibility Criteria

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

You may qualify if:

  • diagnosis of type 2 diabetes according to the American Diabetes Association (ADA) criteria at least six months before the study
  • age 18 years or older, literacy in and ability to speak Turkish,
  • absence of communication/mental problems,
  • willingness to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul

Istanbul, Kartal, 34862, Turkey (Türkiye)

Location

Related Publications (1)

  • Dincer B, Kocali C, Elveren T, Demir S, Demir K, Dolu FN, Feyizoglu G. The Effectiveness of Diabetic Foot Wound Prevention Training Given with Pecha Kucha (20*20) Presentation Technique: A Randomized Controlled. Int J Low Extrem Wounds. 2025 Feb 13:15347346251318778. doi: 10.1177/15347346251318778. Online ahead of print.

MeSH Terms

Conditions

Diabetic FootDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic NeuropathiesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Assuming a power of 80% and an α risk of. 05, a sample size of 120 was determined to be appropriate. Considering the possibility of missing data, the study initially included 65 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 62 participants in the experimental group and 63 in the control group, due to some participants withdrawing.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Associate Professor

Study Record Dates

First Submitted

December 29, 2024

First Posted

January 10, 2025

Study Start

December 30, 2023

Primary Completion

June 23, 2024

Study Completion

October 2, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations