Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation

Ulcerative Colitis Clinical Trial

Official title:

Veränderungen Des Faecalen Calprotectinwertes Und Teilhabebezogener Scores in Folge Einer dreiwöchigen Phase II Rehabilitation [Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05500040
• Other study ID #: 0008-CED
• Status: Completed
• Start date: August 9, 2022
• Est. completion date: July 26, 2023

Study information

• Verified date: January 2024
• Source: Pensionsversicherungsanstalt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For many people affected by inflammatory bowel disease (IBD), their quality of life and their ability to participate in their professional and social lives are severely restricted. Rehabilitation measures based on the biopsychosocial ICF model aim to support the restoration of these abilities. Physiological parameters (e.g. biomarkers) as well as patient-reported outcomes (PROs) can be used to assess the success of ICF-based rehabilitation measures and to optimize them. A suitable biomarker to monitor inflammation in IBD patients is faecal calprotectin. In addition, PROs that support patients in providing information, for example on their health-related quality of life or on their subjective ability to work, can provide information on the individual social and occupational participation ability of the patients. The aim of this project is to investigate changes in a biomarker (calprotectin) as well as in selected PROs after a three-week inpatient phase II rehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Crohn's Disease or Ulcerative Colitis

• Participation in an inpatient phase II rehabilitation

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Crohn Disease
• Ulcerative Colitis

Intervention

Behavioral:
• Multimodal Rehabilitation
The rehabilitation measure is based on the biopsychosocial ICF model of the WHO. A multidisciplinary team of therapists looks after the patients during their stay in rehabilitation. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to their needs.

Locations

Country	Name	City	State
Austria	Rehabilitationszentrum Bad Aussee	Vienna	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Pensionsversicherungsanstalt

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faecal Calprotectin	Faecal calprotectin is a biochemical measurement of the protein calprotectin in the stool. Elevated faecal calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation, including inflammation caused by inflammatory bowel disease.	3 weeks of inpatient rehabilitation
Primary	Ced Disk	The Ced Disk measures IBD-related impairments in different dimensions i.e., abdominal pain, bowel control, interpersonal interactions, education and work, sleep, energy, emotions, body image, sexuality, joint pain (Min. = 0, Max. = 10). Lower values indicate less impairments in the respective dimensions.	3 weeks of inpatient rehabilitation
Primary	European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)	The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions.; Moreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. = 100). Lower values indicate less positive ratings of health.	3 weeks of inpatient rehabilitation
Primary	Patient Health Questionnaire-4 (PHQ-4)	The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min. = 0, Max = 4). Lower values indicate less impairments.	3 weeks of inpatient rehabilitation
Primary	Work ability index (WAI)	The Work Ability Index (WAI) is an instrument for assessing work ability. (Min. = 7, Max = 49). Lower values indicate less subjective work ability.	3 weeks of inpatient rehabilitation