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Open Access 13-11-2024 | Fatigue

Psychometric evaluation of the Functional Assessment of chronic illness therapy–fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn’s disease

Authors: Miguel Regueiro, Sylvia Su, Aisha Vadhariya, Xian Zhou, Frederick Durand, Larissa Stassek, Ariane K. Kawata, Claudine Clucas, Vipul Jairath

Published in: Quality of Life Research | Issue 2/2025

Abstract

Purpose

To provide further evidence on the psychometric properties of the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) in moderately to severely active Crohn’s disease (CD), and to determine thresholds for meaningful improvement in fatigue.

Methods

The FACIT-Fatigue is a 13-item patient-reported outcome measure (range, 0–52) assessing fatigue over the previous week. Using pooled data from the Phase 3 VIVID-1 study of moderately to severely active CD, psychometric properties of FACIT-Fatigue were evaluated up to Week 52. The Patient Global Rating of Severity (PGRS) and Patient Global Impression of Change (PGIC) were used as primary anchors to estimate the FACIT-Fatigue score change representing meaningful improvement.

Results

Psychometric analyses included 1065 adults. The FACIT-Fatigue demonstrated good internal consistency, and correlations between individual items and the total score were moderate to strong. The FACIT-Fatigue score showed moderate to strong correlations with other patient-reported assessments and weak correlations with endoscopic/laboratory assessments. The FACIT-Fatigue differentiated between distinct groups of participants varying in disease severity, quality of life, and fatigue based on PGRS and other assessments. FACIT-Fatigue improvements during the study differed significantly between most PGRS change and PGIC categories. Anchor-based estimates suggested a 6–9-point increase in the FACIT-Fatigue total score as meaningful improvement.

Conclusions

The FACIT-Fatigue demonstrated strong psychometric properties in the VIVID-1 population of adults with moderately to severely active CD and determined a FACIT-Fatigue score change threshold representing meaningful improvement.

Trial registration

NCT03926130. Registered 23 April 2019, https://clinicaltrials.gov/study/NCT03926130.

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Title: Psychometric evaluation of the Functional Assessment of chronic illness therapy–fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn’s disease
Authors: Miguel Regueiro
Sylvia Su
Aisha Vadhariya
Xian Zhou
Frederick Durand
Larissa Stassek
Ariane K. Kawata
Claudine Clucas
Vipul Jairath
Publication date: 13-11-2024
Publisher: Springer New York
Keywords: Fatigue
Crohn's Disease
Published in: Quality of Life Research / Issue 2/2025
Print ISSN: 0962-9343
Electronic ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-024-03829-3

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Psychometric evaluation of the Functional Assessment of chronic illness therapy–fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn’s disease

Abstract

Purpose

Methods

Results

Conclusions

Trial registration

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Please log in to get access to this content

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