Desarrollo de la Escala de Medición del Autocuidado SC-IBD (SC-IBD)
Desarrollo de una Escala de Medición del Autocuidado para Pacientes con Enfermedad Inflamatoria Intestinal (EII) y su Aplicación en un Entorno Ambulatorio
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Daniele Napolitano, RN
- Número de teléfono: +393382650440
- Correo electrónico: daniele.napolitano@policlinicogemelli.it
Ubicaciones de estudio
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RM
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Roma, RM, Italia, 00168
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Contacto:
- Daniele Napolitano, RN
- Número de teléfono: +393382650440
- Correo electrónico: daniele.napolitano@policlinicogemelli.it
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Investigador principal:
- Daniele Napolitano, RN
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Psychometric Validation of the SC-IBD Scale
Periodo de tiempo: Baseline to 3 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Qualitative Themes of Self-Care in Patients with IBD
Periodo de tiempo: Baseline
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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
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Psychological Distress Measured by DASS-21
Periodo de tiempo: Baseline
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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
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Health-Related Quality of Life Assessed by SF-12
Periodo de tiempo: Baseline
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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
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Illness Perception Measured by BIPQ
Periodo de tiempo: Baseline
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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
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Perceived Disease Control Measured by IBD-Control
Periodo de tiempo: Baseline
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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
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Food Literacy Assessed by the Short Food Literacy Questionnaire
Periodo de tiempo: Baseline
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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
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Daniele Napolitano, RN, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 8158 - SC-IBD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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