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

NCT06753799 | Completed DMC

• 1 other identifier: SBUniversitesi2024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Foot Ulcer, Diabetic; Patient Engagement; Self Efficacy; Wound Healing; Nursing

Keywords

Diabetic foot ulcer; patient participation; self-efficacy; wound healing; nursing

Outcome Measures

Primary Outcomes (3)

• Change in ulcer size

  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

  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

  "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

Study Arms (2)

The intervention group

ACTIVE COMPARATOR

The intervention group received training based on Social Cognitive Learning Theory

Behavioral: The intervention group received training based on Social Cognitive Learning Theory.

The control group

NO INTERVENTION

The control group received routine clinical training (is in the form of verbal information)

Interventions

The intervention group received training based on Social Cognitive Learning Theory. BEHAVIORAL

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.

The intervention group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Fadime Koyuncu: lead

Study Sites (1)

University of Health Sciences Gulhane Faculty of Nursing

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot; Patient Participation

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Fadime Koyuncu, 2

  University of Health Sciences Gulhane Faculty of Nursing

  STUDY CHAIR

• Kerim Bora YILMAZ, 3

  Gulhane Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Research Assistant

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 31, 2024
• Study Start: January 19, 2024
• Primary Completion: April 19, 2024
• Study Completion: September 27, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)