Clinical trial NCT04876690: A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas
Official title: Quality of Life of Crohn's Disease Patients With Complex Perianal Fistulas: an Observational, Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Rectal Fistula
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with CD and CPFs in the Portuguese routine clinical practice will be assessed.

Brief summary: The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting.

Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.

Detailed description: This is a national, observational, cross-sectional study. The study will assess the general QoL among CD participants with CPFs in the Portuguese routine clinical practice.

This study will enroll approximately 80 participants. All participants will be enrolled in one observational cohort.

The data will be collected retrospectively, from the medical records, on healthcare resource utilization and on the pharmacological and surgical treatments used for the management of CPFs in the three years prior to the inclusion visit.

This multi-center trial will be conducted in Portugal. The overall duration of this study is approximately 8 months.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with CD.
2. Presence of CPF(s), defined as \>=1 of the following criteria:

   * High intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric location;
   * \>=2 external openings;
   * Associated collections.
3. Attending routine gastroenterology appointments at the participating hospitals.

Exclusion Criteria:

1. Diagnosed with ulcerative colitis or indeterminate inflammatory bowel disease (IBD).
2. With non-complex fistulas or with fistulas types other than perianal (example, rectovaginal).

Primary outcomes:
measure: Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]
timeFrame: At inclusion visit (Day 1)
measure: Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])
timeFrame: At inclusion visit (Day 1)
Secondary outcomes:
measure: Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
timeFrame: At inclusion visit (Day 1)
measure: Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants
timeFrame: At inclusion visit (Day 1)
measure: Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants
timeFrame: At inclusion visit (Day 1)
measure: Fecal Incontinence as Assessed by Wexner Score
timeFrame: At inclusion visit (Day 1)
measure: Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score
timeFrame: At inclusion visit (Day 1)
measure: Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years
timeFrame: Up to 3 years prior to the inclusion visit at Day 1
measure: Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics
timeFrame: At inclusion visit (Day 1)
measure: Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics
timeFrame: At inclusion visit (Day 1)
measure: Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF
timeFrame: Up to 3 years prior to the inclusion visit at Day 1
measure: Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables
timeFrame: At inclusion visit (Day 1)
measure: Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables
timeFrame: At inclusion visit (Day 1)
measure: Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
timeFrame: At inclusion visit (Day 1)
measure: Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables
timeFrame: At inclusion visit (Day 1)
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra (CHUC)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario de Lisboa Central (CHULC)
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria (CHULN-HSM)
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Sao Joao (CHUSJ)
city: Viseu
country: Portugal
facility: Centro Hospitalar Tondela-Viseu (CHTV)
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: