The Effect of Education on Patient Care Outcomes in Individuals With Diabetic Foot Ulcer

December 22, 2024 updated by: Fadime Koyuncu

The Effect of Education Based on Social Cognitive Learning Theory on Patient Participation, Self-Efficacy and Wound Healing in Individuals With Diabetic Foot Ulcer

The aim of this study is to determine the effect of Social Cognitive Learning Theory-based education on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers. The research was conducted with 52 patients (25 intervention and 27 control) with Wagner 2 diabetic foot ulcers at Gülhane Training and Research Hospital between January and September 2024.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was conducted in four stages: first application to the clinic, 1st month, 2nd month and 3rd month. While the Social Cognitive Learning Theory was applied to the intervention group, only the currrent clinical education was provided to the control group. The research data were collected using the "Data Collection Form Regarding Participants' Identifying Characteristics", "Diabetic Foot Information Form", "Metabolic Status and Wound Follow-up Form", "Patient Participation Scale" and "Diabetic Foot Care Self-Efficacy Scale". The results of this study show that education based on Social Cognitive Learning Theory is effective on patient participation, self-efficacy and wound healing in individuals with diabetic foot ulcers.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • UNIVERSITY OF HEALTH SCIENCES GULHANE FACULTY OF NURSING

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals 18 years of age or older Agree to participate in the study Have type 2 diabetes Have a Wagner classification score of 2 Have the same wound care protocols (epidermal growth factor/hyalunoric acid containing cream and dressing with gauze)

Exclusion Criteria:

  • Having communication difficulties and mental retardation Having vision and manual dexterity problems Having diabetic foot infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The intervention group
The intervention group received training based on Social Cognitive Learning Theory
Behavioral: The intervention group received training based on Social Cognitive Learning Theory.
One of the theories that provides a conceptual framework for the learning and behavior change process is Social Cognitive Learning Theory. Verbal information is commonly provided in the education of individuals with diabetic foot ulcers. The difference of this study from other studies is that an educational booklet, an educational video and a demonstration method with a diabetic foot model are used during the education within the scope of theory-based education.
No Intervention: The control group
The control group received routine clinical training (is in the form of verbal information)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ulcer size
Time Frame: From enrollment to the end of treatment at 3 months
The result obtained by multiplying the length and width measurements of the ulcer with each other expresses the ulcer size in cm2.
From enrollment to the end of treatment at 3 months
Change in patient participation
Time Frame: From enrollment to the end of treatment at 3 months
It was assessed with the Patient Health Engagement Scale (PHE-s). The PHE-s was developed based on a 4-stage model of patient. Items of the PHE-s: blackout, arousal, adhesion and eudaimonic project. Patients were asked to respond by positioning themselves between one and seven points in relation to their experience.
From enrollment to the end of treatment at 3 months
Change in self-efficacy
Time Frame: From enrollment to the end of treatment at 3 months
"Participants achieved a response if they scored a self efficacy status of 0 or 10 on a scale ranging from 0 (worst outcome) to 90 (best outcome)."
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fadime Koyuncu

Investigators

  • Study Chair: Fadime Koyuncu, 2, UNIVERSITY OF HEALTH SCIENCES GULHANE FACULTY OF NURSING
  • Study Chair: Kerim Bora YILMAZ, 3, Gulhane Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2024

Primary Completion (Actual)

April 19, 2024

Study Completion (Actual)

September 27, 2024

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 22, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 22, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBUniversitesi2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

all collected IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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