A Multicentre Prospective Observational Study to Assess Health Related Quality of Life in Crohn's Disease Patients With Complex Perianal Fistula Before and After Treatment: the CALYPSO Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 20
- 主要终点
- Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 12 After Treatment Initiation for CPF
研究概览
简要总结
The purpose of this study is to assess the impact of treatment (medical and/or surgical) on Health-related Quality of Life (HRQoL) in participants with Crohn's Disease (CD) and Complex Perianal Fistula (CPF), by the Quality of Life in patients with Anal Fistula Questionnaire (QoLAF-Q), at 12 months after treatment initiation in routine clinical practice.
详细描述
This is a prospective follow-up post-authorization observational study of participants with CD and CPF. The study will provide real-world data on how CPF treatments in CD participants affect their HRQoL.
The study will enroll approximately 300 participants. All participants will be enrolled in one observational cohort.
This multi-center trial will be conducted in Spain. The study will collect data from a routine medical practice visits for CD participants with CPF and an application that will be designed ad hoc and will passively record participant's data. The overall duration of this study will be approximately 31 months. Participants will be followed up at Months 6 and 12 post-treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with CD and CPF (defined as a fistula meeting any of the following criteria: high location [high intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric], multiple external openings, perianal abscess, anal stenosis, or proctitis).
- •Has tried and failed at least one prior treatment for CPF.
- •Starting a new pharmacological or surgical treatment for CPF.
排除标准
- •Diagnosed with indeterminate/unspecified type of inflammatory bowel disease (IBD).
- •Diagnosed with ulcerative colitis.
- •Diagnosed with fistula other than CPF (example rectovaginal).
- •Treated with darvadstrocel or other stem cells-based therapies within the eligibility period.
- •Previous fecal incontinence.
- •Lost to site follow-up for reasons other than death.
- •Participates or plans to participate in any interventional clinical trial.
- •Non fluent in Spanish.
结局指标
主要结局
Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 12 After Treatment Initiation for CPF
时间窗: Baseline and Month 12
QoLAF-Q evaluates quality of life (QoL) among participants with both simple and complex anal fistula (AF). It is composed of a total of 14 items with a Likert scale from 1 to 5 points. Its score range is the following: zero impact=14 points; limited impact=15 to 28 points; moderate impact=29 to 42 points; high impact=43 to 56 points; and very high impact=57 to 70 points.
次要结局
- Number of Participants With Change From Baseline in QoLAF-Q Scores at Month 6 After Treatment Initiation for CPF(Baseline and Month 6)
- Percentage of Participants With Clinically Significant Change From Baseline in QoLAF-Q Score at Months 6 and 12 After Treatment for CPF(Baseline, Months 6 and 12)
- Change From Baseline in EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) Scores at Months 6 and 12 After Treatment for CPF(Baseline, Months 6 and 12)
- Change From Baseline in Faecal Incontinence Quality of Life Scale (FIQOL) Scores at Months 6 and 12 After Treatment for CPF(Baseline, Months 6 and 12)
- Change From Baseline in Perceived Stress Scale (PSS) Scores at Months 6 and 12 After Treatment for CPF(Baseline, Months 6 and 12)
- Number of Participants With the Presence of new CPF at Months 6 and 12(Months 6 and 12)
- Number of Participants With Comorbidities Based on Charlson Comorbidity Index(Baseline)
- Number of Participants With Comedications for Treatment of CD and Fistula(Baseline)
- Number of Participants With Target CPF(Baseline)
- Change From Baseline in International Index of Erectile Function (IIEF) Scores at Months 6 and 12 After Treatment for CPF(Baseline, Months 6 and 12)
- Number of Participants Based on Biological Data(Baseline, Months 6 and 12)
- Change From Baseline in Female Sexual Function Index (FSFI) Scores at Months 6 and 12 After Treatment for CPF(Baseline, Months 6 and 12)
- Number of Participants Based on Type of Treatment, Dose, Dose Frequency and Date of Initiation(Baseline)
- Montreal Classification Assessed at Baseline(Baseline)
- Number of Participants With Clinical characteristics Based on Harvey Bradshaw Index (HBI)(Baseline, Months 6 and 12)
- Number of Participants With Clinical Characteristics Based on Perianal Crohn´s Disease Activity Index (PDAI) or Fistula Drainage Assessment (FDA)(Baseline, Months 6 and 12)
- Number of Occurrences of Treatment Switching or Dose Change(Months 6 and 12)
- Number of Participants Based on Methods Used to Evaluate the Response to Different Treatments for CPF in Routine Clinical Practice(Months 6 and 12)
- Number of Participants Based on Effectiveness of Different Treatment Options for CPF Grouped According to Therapeutic Class(Months 6 and 12)
- Health Care Resources Utilization (HCRU)(Baseline, Months 6 and 12)
- Correlation Between the Change in CD Participant's Scores in the QoLAF-Q, the EQ-5D-5L and Rapid Assessment Faecal Incontinence Score (RAFIS)(Baseline, Months 6 and 12)
- Relation Between Participants QoLAF-Q Score and Clinical Variables(Baseline)