A Study of the Quality of Life in Adults With Crohn's Disease With Complex Perianal Fistulas

Crohn Disease Clinical Trial

— CONFLICT  

Official title:

Quality of Life of Crohn's Disease Patients With Complex Perianal Fistulas: an Observational, Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04876690
• Other study ID #: IBD-5007
• Status: Completed
• Start date: July 9, 2021
• Est. completion date: May 27, 2022

Study information

• Verified date: June 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Crohn Disease
• Fistula
• Rectal Fistula

Locations

Country	Name	City	State
Portugal	Centro Hospitalar e Universitario de Coimbra (CHUC)	Coimbra
Portugal	Centro Hospitalar Universitario de Lisboa Central (CHULC)	Lisboa
Portugal	Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria (CHULN-HSM)	Lisboa
Portugal	Centro Hospitalar Universitario de Sao Joao (CHUSJ)	Porto
Portugal	Centro Hospitalar Tondela-Viseu (CHTV)	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Based on General Quality of Life (QoL) as Measured by the Short Form Health Survey (SF-12)	Number of participants based on QoL will be measured using SF-12. SF-12 is 12-item self-report that assesses physical and mental health related quality of life. Results will be expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100. Higher scores indicate better physical functioning.	Up to Month 8
Secondary	Number of Participants Based on QOL as Measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	The SIBDQ is an instrument used to assess quality of life and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The total score will be reported and will range from 10 to 70 with a higher score indicates a better health-related QoL.	Up to Month 8
Secondary	Number of Male Participants Characterized Based on Sexual Quality of Life-Male (SQOL-M)	SQOL-M will assess the relationship between male sexual dysfunction and quality of life. It contains 11 items, each items are scored from 1 to 6 points (worst to best)-completely Agree = 1 to Completely Disagree = 6. The total score can range from 11 to 66 points.	Up to Month 8
Secondary	Number of Female Participants Characterized Based on Sexual Quality of Life-Female (SQOL-F)	SQOL-F will assess the relationship between female sexual dysfunction and quality of life. It consists of 18 items, rated using a six-point scale (completely agree to completely disagree). The total score can range from 18 to 108 points. Higher scores indicate better female sexual quality of life.	Up to Month 8
Secondary	Number of Participants With Fecal Incontinence Assessed by Wexner Score	Fecal incontinence is measured by Wexner Score. It consists of five questions to assess the degree of incontinence (solid, liquid, gas, wears pad, lifestyle alteration). The frequency of each type of incontinence is rated on a scale ranging from 0 (never) to 4 (always or to once a day) so that the sum of the frequencies add up to a total score that may range from 0 to 20. Higher scores indicate higher levels of incontinence.	Up to Month 8
Secondary	Number of Participants Based on Impact on Social/Work Activities and Work Productivity Assessed by Work Productivity and Activity Impairment (WPAI)	WPAI scores will be used to describe the indirect healthcare resources. It is self-administered 6-item questionnaire (scale of 0-10) which assess the effect of disease on work productivity in the past 7 days obtained for absenteeism (work time missed), presenteeism (impairment at work / reduced on-the-job effectiveness), work productivity loss (overall work impairment / absenteeism plus presenteeism) and activity Impairment / disability. Higher scores indicates greater impairment.	Up to Month 8
Secondary	Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years	Number of participants will be characterized based on HCRU associated with complex perianal fistulas (CPFs) management within the three years prior to the inclusion visit will be collected. HCRU includes gastroenterology and other medical specialty appointments for the management of CPF; emergency room visits due to CPF; hospitalizations (greater than or equal to [>=] 24 hours) due to CPF: Date of admission, Total length of stay (LoS), intensive care unit (ICU) admission (yes/no). If yes: LoS.	Within previous 3 years
Secondary	Number of Participants Characterized by Sociodemographic and Anthropometric Characteristics	Sociodemographic and anthropometric variables will include age (in years), sex (male or female), and body mass index (BMI).	Up to Month 8
Secondary	Number of Participants With Moderate to Severe Crohn's disease (CD) Stratified by Clinical Characteristics	The Montreal classification index for CD is used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is ileum, Location 2 (L2) is colonic disease, Location 3 (L3) is ileocolon and Location 4 (L4) is isolated upper gastrointestinal (GI) tract disease. The first three categories (L1-L3) is combined with L4 where disease sites coexisted. There are 4 different categories for the behavior of the disease activity: Behavior 1 (B1) is non stenosing or non penetrating; Behavior 2 (B2) was stenosing; Behavior 3 (B3) is penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) is defined as the presence of perianal abscesses or fistulae.	Up to Month 8
Secondary	Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF	For each pharmacological treatment (antibiotics, monoclonal antibodies and immunosuppressants), participants will be divided into three categories (current users, past users, and non-users) considering the three years prior to the inclusion visit.	Within previous 3 years
Secondary	Correlation Between General QoL (PCS-12 and MCS-12) and the Participants Socio-demographic, Anthropometric and Clinical Characteristics	Associations between general QoL (for the two SF-12 meta-scores: PHC and MHC) and qualitative variables will be tested with the t-test for independent samples/analysis of variance (ANOVA) for two/three or more independent samples or with the Mann-Whitney/Kruskal-Wallis non-parametric tests, according to the assumption validations of the statistical test. Associations between general QoL (for PHC and MHC) and quantitative variables will be performed through Pearson correlation coefficient or Spearman correlation coefficient.	Up to Month 8

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