Clinical Trials

Overview

About this study

This is a prospective observational cohort study assessing baseline and short-term changes in patient-reported outcomes and physical activity in patients with fibrotic interstitial lung disease (f-ILD). Primary endpoints will be the prevalence and extent of anxiety and depression at baseline and over time (6 months) with focused exploration of predictive and modifying covariables, and extent of physical activity at baseline and over time (6 months) and its impact on self-reported quality of life. All patients with f-ILD seen at Mayo Clinic Rochester will be enrolled by telephonic or in-person screening, and formally consented before enrollment. Measurements of symptom burden, psychologic and emotional health, and respiratory-related quality of life will be assessed with 9 standardized questionnaires, provided to participants electronically through an crypted REDCap link. Physical activity will be measured using the Actigraph GT3X-BT, a standardized research activity monitor worn on the wrist continuously for seven days. Mean steps per day and mean minutes of sedentary and moderate activity time will be serve as quantifiable physical activity endpoints. Baseline demographics, f-ILD disease subtype and duration, pulmonary function testing, radiologic findings, medical comorbidities, and social determinants of health will be obtained and followed over the 6 month period, in conjunction with repeated questionnaire and physical activity measures at enrollment, 3, and 6 months. Statistical analysis will involve descriptors of symptom burden, emotional and psychological wellbeing, and health-related quality at baseline and over time, as stratified by a prior subgroups or covariables. Particular focus will be on the extent and severity of anxiety and depression and any correlating or modifying variables, as assessed by multivariable logistic regression or predictive modeling with elastic net. Similar descriptors of physical activity extent and change over time correlating with baseline or changes in clinical, demographic, or patient-reported outcomes will also be pursued. For modeling and covariable adjustment, 250-300 participants will be enrolled to allow adjustment for up 10 variables for each outcome.    

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Participating Mayo Clinic locations

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