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NCT Number: NCT06753799

The Effect of Education on Patient Care Outcomes 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.

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Key information

Conditions

Foot Ulcer, Diabetic Behavior Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Health Behavior Leg Ulcer Nursing Patient Acceptance of Health Care Patient Engagement Patient Participation Self Efficacy Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Treatment Adherence and Compliance Vascular Diseases Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Gulhane Faculty of Nursing

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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)."

Sponsors and collaborators

Lead sponsor

Fadime Koyuncu

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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