The purpose of this interventional study is to identify which combination of remote monitoring devices (e.g. home spirometry, pulse oximetry, scale, ePROs) is the most feasible (as defined by adherence, retention, and data completeness) and acceptable when used for the detection of clinically significant Interstitial Lung Disease events.
age 18 or older
English speaking
have a UCSF diagnosis of one of the major ILD subtypes seen in the ILD Clinic (Idiopathic Pulmonary Fibrosis, Chronic Hypersensitivity Pneumonitis, Connective-tissue disease related ILD, Sarcoidosis, Familial Fibrosis). Languages are limited to those for which both device instructional materials and user support are available (written and video). The ILD diagnosis will be based on multidisciplinary conference review, which is the diagnostic gold standard. We have restricted the ILD subtypes to those for which there is efficacy data for RPM or comparable clinical trajectories, and subtypes that account for >10% of the ILD diagnoses seen at UCSF.
Patients who are unable provide informed consent for any reason or are acutely ill.
Factorial
Spirometer
DeviceHome spirometry will be conducted weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece).
Oximeter
DeviceOxygen saturation levels will be measured daily using a pulse oximeter.
Scale
DeviceWeight will be measured weekly using a wireless scale provided by the study.
ePROs (electronic patient reported outcomes)
Other interventionBrief electronic symptom questionnaires will be completed through a secure app which will be downloaded on participant's phone.
Detection rate of clinically significant ILD events
Measured using a composite endpoint of acute exacerbation, hospitalization, or rapid disease progression, defined as a ≥10% relative decline in FVC over 3 months
Time to detection of first ILD event
Measured using a composite endpoint of acute exacerbation, hospitalization, or rapid disease progression, defined as a ≥10% relative decline in FVC over 3 months.
Adherence
Adherence to remote monitoring protocol, defined as the proportion of measurements completed \>=67% of weeks with full data entry)
Retention
Primary: Participant retention at 12 months (target \>=80%)
Change in health-related quality of life
Measured by administration of King's Brief ILD Questionnaire (K-BILD). K-BILD is a 15-item health status questionnaire with each item reported on a 7-point Likert response scale across three domains: breathlessness and activities, psychological, chest symptoms. The raw scores are logit transformed onto a standardized 0-100 scale, where 100 represents the best health status. The minimally clinically important change difference for the total score is = 5-point change.
Change in health-related quality of life
Measured by administration of the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 scores each of the 7 items on a scale of 0-3 with the total score range from 0-21 with a higher score indicating higher anxiety.
Change in FVC
Measured by comparing changes in FVC in home spirometry vs clinic-based spirometry
Proportion of patients with ≥10% decline in FVC
Measured by FVC values collected through home spirometry.
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University of California, San Francisco
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
patientMpower Ltd.
Collaborator
