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

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]

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Behavioral: Multimodal Rehabilitation

• Study Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

• Study Contact: Name: Benedikt Steininger, MSc; Phone Number: +435030326715; Email: benedikt.steininger@pv.at

Study Locations

• Austria
  • Styria
    • Vienna, Styria, Austria, 8990
      • Rehabilitationszentrum Bad Aussee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Rehabilitation patients with IBD in inpatient rehabilitation

Description

Inclusion Criteria:

• Clinical diagnosis of Crohn's Disease or Ulcerative Colitis
• Participation in an inpatient phase II rehabilitation

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with IBD - Crohn's Disease	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.
Patients with IBD - Ulcerative Colitis	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pensionsversicherungsanstalt
• Investigators: Study Chair: David Felder, Mag., Pensionsversicherungsanstalt

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 0008-CED

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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