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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. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr
  • Telefonnummer: +962779084560
  • E-post: JAWAD_0799@YAHOO.COM

Studiesteder

  • Jordan
    • Dours
      • Jerash, Dours, Jordan, 009627
        • Ministry of Health Primary Healthcare Centers
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jawad AHMAD ABU-SHENNAR, Asst.Prof.Dr

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Kontrollgruppe
Atferdsmessig: 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.
Eksperimentell: Educational Program Group
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain Intensity Measured Using the Numeric Rating Scale (NRS)
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diabetes Self-Efficacy Measured Using the Diabetes Self-Efficacy Scale (DSES)
Tidsramme: 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).

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Foot Self-Care Behaviors Measured Using the Diabetic Foot Self-Care Questionnaire (DFSQ-UMA-En)
Tidsramme: 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
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jerash Private University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mai 2026

Primær fullføring (Antatt)

30. mai 2026

Studiet fullført (Antatt)

1. oktober 2026

Datoer for studieregistrering

Først innsendt

24. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

4. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DF-EDU-RCT-2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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