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

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ClinicalTrials.gov Identifier: NCT05500040
Recruitment Status : Recruiting
First Posted : August 12, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Pensionsversicherungsanstalt

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.

Condition or disease Intervention/treatment
Crohn Disease Ulcerative Colitis Behavioral: Multimodal Rehabilitation

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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]
Actual Study Start Date : August 9, 2022
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Faecal Calprotectin [ Time Frame: 3 weeks of inpatient rehabilitation ]
    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.

  2. Ced Disk [ Time Frame: 3 weeks of inpatient rehabilitation ]
    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. European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) [ Time Frame: 3 weeks of inpatient rehabilitation ]

    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.


  4. Patient Health Questionnaire-4 (PHQ-4) [ Time Frame: 3 weeks of inpatient rehabilitation ]
    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.

  5. Work ability index (WAI) [ Time Frame: 3 weeks of inpatient rehabilitation ]
    The Work Ability Index (WAI) is an instrument for assessing work ability. (Min. = 7, Max = 49). Lower values indicate less subjective work ability.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Rehabilitation patients with IBD in inpatient rehabilitation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500040


Contacts
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Contact: Daniel Graf, Mag. Dr. +435030326725 daniel.graf@pv.at

Locations
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Austria
Rehabilitationszentrum Bad Aussee Recruiting
Vienna, Styria, Austria, 8990
Contact: Christoph Mauel, Dr. MSc    +4336225258172200    christoph.mauel@pv.at   
Sponsors and Collaborators
Pensionsversicherungsanstalt
Investigators
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Study Chair: David Felder, Mag. Pensionsversicherungsanstalt
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Responsible Party: Pensionsversicherungsanstalt
ClinicalTrials.gov Identifier: NCT05500040    
Other Study ID Numbers: 0008-CED
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases