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Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot (DF-EDU-RCT)

30 aprile 2026 aggiornato da: JAWAD AHMAD ABU-SHENNAR, Jerash Private University

Effectiveness of a Structured Educational Program on Pain Intensity, Self-Efficacy, Foot Self-Care Behaviors, and Health-Related Quality of Life Among Adults With Diabetic Foot: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effectiveness of a structured educational program on pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life among adults with diabetic foot. Diabetic foot complications are a major cause of morbidity, reduced quality of life, and disability among patients with diabetes mellitus. Poor self-care practices and inadequate knowledge contribute significantly to the progression of foot ulcers and related complications.

Participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured educational program designed to improve knowledge, self-management skills, and adherence to recommended diabetic foot care practices. The control group will receive routine care provided by the healthcare facility.

The educational program focuses on key areas including foot hygiene, daily foot inspection, appropriate footwear, glycemic control, and early identification of warning signs of complications. The primary outcomes of the study include changes in pain intensity, self-efficacy, foot self-care behaviors, and health-related quality of life, which will be assessed at baseline and after the intervention period.

The findings of this study are expected to contribute to improving nursing educational interventions and enhancing self-management outcomes among patients with diabetic foot.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Diabetic foot is one of the most serious and common complications of diabetes mellitus, often leading to infection, ulceration, hospitalization, and in severe cases, lower limb amputation. It significantly affects patients' physical, psychological, and social well-being, thereby reducing overall quality of life. Despite the availability of preventive guidelines, many patients continue to demonstrate inadequate foot self-care behaviors, poor adherence to management recommendations, and low self-efficacy in managing their condition.

This study is designed as a randomized controlled trial to assess the effectiveness of a structured educational program on improving clinical and behavioral outcomes among adults with diabetic foot. The study will be conducted at selected healthcare settings, and eligible participants will be randomly allocated into either an intervention group or a control group using a predefined randomization method.

The intervention group will receive a structured educational program delivered through planned teaching sessions. The program is based on evidence-based diabetic foot care guidelines and includes theoretical and practical components. Topics covered include diabetic foot anatomy and risk factors, daily foot inspection techniques, proper hygiene practices, nail and skin care, appropriate footwear selection, wound prevention strategies, glycemic control, and early recognition of complications. Educational materials such as brochures, demonstrations, and interactive discussions will be used to enhance understanding and adherence.

The control group will receive routine care and standard education provided by the healthcare facility without additional structured intervention.

Outcome measures will be assessed at baseline and post-intervention. The primary outcomes include:

Pain intensity measured using a validated pain scale Self-efficacy assessed through a standardized self-efficacy instrument Foot self-care behaviors measured using a diabetic foot care behavior scale Health-related quality of life assessed using a validated quality of life questionnaire

Data will be analyzed to determine the effectiveness of the structured educational program in improving these outcomes compared to routine care.

The study is expected to provide evidence supporting the integration of structured educational programs into nursing practice to improve self-management, reduce complications, and enhance quality of life among patients with diabetic foot.

Tipo di studio

Interventistico

Iscrizione (Stimato)

400

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
  • Numero di telefono: +962779084560
  • Email: JAWAD_0799@YAHOO.COM

Luoghi di studio

  • Giordania
    • Dours
      • Jerash, Dours, Giordania, 009627
        • Ministry of Health Primary Healthcare Centers
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Adults aged 18 years and older
  • Diagnosed with diabetic foot
  • Able to communicate effectively
  • Willing to participate in the educational program
  • Able to provide written informed consent

Exclusion Criteria:

  • Patients with severe or unstable medical conditions (e.g., advanced heart failure, renal failure, or active infections) that may interfere with participation
  • Patients with major lower-limb amputation or severe foot deformities preventing participation in the educational program or assessments
  • Patients with cognitive impairments, psychiatric disorders, or communication difficulties affecting understanding or compliance
  • Pregnant or lactating women
  • Patients who refuse to provide informed consent or withdraw at any stage of the study

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Gruppo di controllo
Comportamentale: Structured Educational Program
A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management. The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications. Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.
Sperimentale: Educational Program Group
Comportamentale: Structured Educational Program
A structured educational program designed for adults with diabetic foot to improve self-care practices and disease management. The program includes planned teaching sessions delivered by trained nursing staff and covers key topics such as foot hygiene, daily foot inspection, proper nail and skin care, appropriate footwear selection, glycemic control, and early identification of complications. Educational strategies include lectures, demonstrations, printed materials, and interactive discussions to enhance participants' knowledge, self-efficacy, and adherence to recommended foot care behaviors.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain Intensity Measured Using the Numeric Rating Scale (NRS)
Lasso di tempo: Baseline and post-intervention (4-8 weeks).
Change in pain intensity measured using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
Baseline and post-intervention (4-8 weeks).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES)
Lasso di tempo: Baseline and post-intervention (4-8 weeks).
Change in diabetes self-efficacy measured using the Diabetes Self-Efficacy Scale (DSES). The scale consists of 8 items assessing patients' confidence in managing diabetes-related self-care behaviors. Each item is rated on a 5-point Likert scale ranging from 1 (not at all confident) to 5 (very confident). Total scores range from 8 to 40, with higher scores indicating higher self-efficacy.
Baseline and post-intervention (4-8 weeks).

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Foot Self-Care Behaviors Measured Using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En)
Lasso di tempo: Baseline and post-intervention (4-8 weeks).
Change in foot self-care behaviors measured using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En). The instrument is a validated 16-item self-report questionnaire developed to assess self-care behaviors among patients with diabetes. It includes three domains: foot self-care, self-examination, and footwear/sock management. Items are rated on a Likert scale, and higher scores indicate poorer foot self-care behaviors.
Baseline and post-intervention (4-8 weeks).
Health-Related Quality of Life Measured Using the EQ-5D-5L Questionnaire
Lasso di tempo: Baseline and post-intervention (4-8 weeks).
Change in health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on a 5-level scale ranging from no problems to extreme problems. The EQ-5D index score typically ranges from values below 0 (worse than death) to 1 (full health), where higher scores indicate better health-related quality of life. Additionally, overall health status is assessed using the EQ Visual Analog Scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health).
Baseline and post-intervention (4-8 weeks).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Jerash Private University

Investigatori

  • Investigatore principale: Jawad AHMAD Ahmed, Asst.Prof.Dr, Jerash University, Faculty of Nursing

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

30 maggio 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

24 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 aprile 2026

Primo Inserito (Effettivo)

4 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • DF-EDU-RCT-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data (IPD) will not be shared publicly. The data collected in this study contain sensitive health information related to patients with diabetic foot and will be used exclusively for research purposes within the approved study protocol. To ensure participant confidentiality and comply with ethical and institutional review board requirements, access to the dataset will be restricted to the principal investigator and authorized research team members only. Aggregate results may be published in peer-reviewed journals, but individual-level data will not be made available to other researchers.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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