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

NCT05500040 | Completed

• 1 other identifier: 0008-CED
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Patients with IBD - Crohn's Disease

Behavioral: Multimodal Rehabilitation

Patients with IBD - Ulcerative Colitis

Behavioral: Multimodal Rehabilitation

Interventions

Multimodal Rehabilitation BEHAVIORAL

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 - Crohn's Disease; Patients with IBD - Ulcerative Colitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rehabilitation patients with IBD in inpatient rehabilitation

You may qualify if:

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

Sponsors & Collaborators

• Pensionsversicherungsanstalt: lead

Study Sites (1)

Rehabilitationszentrum Bad Aussee

Vienna, Styria, 8990, Austria

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Doreen Stöhr, Mag.

  Pensionsversicherungsanstalt

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 12, 2022
• Study Start: August 9, 2022
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: March 10, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)