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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Rectal Fistula

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitário de Coimbra (CHUC)
  • Lisboa, Portugal, 1169-050
    • Centro Hospitalar Universitario de Lisboa Central (CHULC)
  • Lisboa, Portugal, 1649-028
    • Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria (CHULN-HSM)
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitário de São João (CHUSJ)
  • Viseu, Portugal, 3504-509
    • Centro Hospitalar Tondela-Viseu (CHTV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with CD and CPFs in the Portuguese routine clinical practice will be assessed.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All Participants; Participants diagnosed with CD and CPF in the Portuguese routine clinical practice will be assessed. Retrospective data on healthcare resource utilization related with CPF management in the previous three years will be obtained from the medical records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Inflammatory Bowel Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Crohn Disease; Rectal Fistula
• Other Study ID Numbers: IBD-5007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No