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Utvikling av SC-IBD Selvhjelpsmålingsskala (SC-IBD)

18. september 2026 oppdatert av: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Utvikling av en egenomsorgsmåleskala for pasienter med inflammatorisk tarmsykdom (IBD) og dens anvendelse i en poliklinisk setting

This study aims to develop and validate a disease-specific self-care measurement scale for patients with Inflammatory Bowel Disease (IBD). The research follows a sequential mixed-methods design: a qualitative phase to identify key self-care concepts, followed by a quantitative phase to test the psychometric properties of the newly developed SC-IBD scale in an outpatient population.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

This study is designed to develop and validate the SC-IBD scale, a disease-specific instrument for measuring self-care in patients with Inflammatory Bowel Disease (IBD). The project uses a sequential exploratory mixed-methods design.

In the qualitative phase, semi-structured interviews will be conducted with outpatients diagnosed with IBD to explore their experiences of self-care across the three theoretical dimensions described in the Middle-Range Theory of Self-Care of Chronic Illness: maintenance, monitoring, and management. The qualitative findings will inform item generation and content validity assessment through a multidisciplinary expert panel.

The quantitative phase will include the administration of the preliminary SC-IBD scale to an outpatient cohort in order to evaluate its psychometric properties, including construct validity, internal consistency, and test-retest reliability. Additional validated instruments (DASS-21, SF-12, BIPQ, IBD-Control, and the Short Food Literacy Questionnaire) will be used to assess convergent and divergent validity and to describe relevant psychological, clinical and behavioral correlates of self-care in IBD.

The ultimate goal of the study is to produce a reliable, valid, and clinically useful tool for assessing self-care behaviors in individuals living with IBD, supporting both research and clinical practice.

Studietype

Observasjonsmessig

Registrering (Antatt)

275

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Italia
    • RM
      • Roma, RM, Italia, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS
        • Ta kontakt med:
        • Hovedetterforsker:
          • Daniele Napolitano, RN

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

The study population consists of adult outpatients diagnosed with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) followed at the IBD outpatient clinic of the Fondazione Policlinico Universitario A. Gemelli IRCCS and affiliated satellite centers. Participants must have received an IBD diagnosis for at least 12 months, be able to read and speak Italian, and be willing to participate in either the qualitative or quantitative phase of the study. A total of 275 patients will be enrolled.

Beskrivelse

Inclusion Criteria:

  • Voluntary willingness to participate in the study.
  • Diagnosis of Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) for at least 12 months.
  • Follow-up in outpatient setting.
  • Age 18 years or older.
  • Ability to read and speak Italian.
  • Ability to understand the study procedures.
  • Signed informed consent.

Exclusion Criteria:

  • Age younger than 18 years.
  • Significant cognitive impairment (e.g., dementia) that may limit participation.
  • Insufficient comprehension of the Italian language.
  • Severe psychiatric disorders that may compromise participation.
  • Severe clinical conditions preventing participation in interviews or questionnaire completion.
  • Refusal to sign the informed consent form.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Psychometric Validation of the SC-IBD Scale
Tidsramme: Baseline to 3 months

Assessment of the psychometric properties of the SC-IBD scale, including internal consistency (e.g., McDonald's Omega), construct validity (exploratory and confirmatory factor analyses), content validity, convergent and divergent validity, and test-retest reliability. Analyses will determine whether the scale reliably and validly measures self-care behaviors in patients with Inflammatory Bowel Disease.
Baseline to 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Qualitative Themes of Self-Care in Patients with IBD
Tidsramme: Baseline

Qualitative analysis of semi-structured interviews to identify recurring themes and patterns of self-care behaviors across the dimensions of self-care maintenance, monitoring, and management, based on the Middle-Range Theory of Self-Care of Chronic Illness. Findings inform the generation and refinement of SC-IBD scale items.
Baseline
Psychological Distress Measured by DASS-21
Tidsramme: Baseline

Assessment of depression, anxiety, and stress using the DASS-21 validated Italian version. Scores will be used to evaluate convergent and divergent validity of the SC-IBD scale and explore associations between self-care and psychological distress.
Baseline
Health-Related Quality of Life Assessed by SF-12
Tidsramme: Baseline

Measurement of physical and mental health components through the SF-12 questionnaire to evaluate relationships between self-care behaviors and quality of life, supporting the SC-IBD validity analysis.
Baseline
Illness Perception Measured by BIPQ
Tidsramme: Baseline

Evaluation of cognitive and emotional representations of illness using the Brief Illness Perception Questionnaire. Correlations with the SC-IBD scale will be used to assess construct validity.
Baseline
Perceived Disease Control Measured by IBD-Control
Tidsramme: Baseline

Assessment of patient-reported control of IBD using the validated Italian version of the IBD-Control questionnaire (extended form with VAS). Used to explore relationships between perceived disease control and self-care behaviors.
Baseline
Food Literacy Assessed by the Short Food Literacy Questionnaire
Tidsramme: Baseline

Measurement of food literacy using the SFLQ (Italian version). Results will help determine whether food literacy acts as a determinant or moderator of self-care in patients with IBD and evaluate convergent validity of the SC-IBD scale.
Baseline

Samarbeidspartnere og etterforskere

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Etterforskere

  • Hovedetterforsker: Daniele Napolitano, RN, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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)

30. oktober 2026

Primær fullføring (Antatt)

30. oktober 2027

Studiet fullført (Antatt)

30. oktober 2028

Datoer for studieregistrering

Først innsendt

20. mars 2026

Først innsendt som oppfylte QC-kriteriene

20. mars 2026

Først lagt ut (Faktiske)

27. mars 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. september 2026

Sist bekreftet

1. mars 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 8158 - SC-IBD

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No, there is no plan to share individual participant data (IPD). Data will remain stored in pseudonymized form within the institution according to GDPR and local ethical requirements.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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