Remote Evaluation and Surveillance of Patients With Interstitial Lung Disease: Transforming ILD Care Delivery With Remote Monitoring

Measured using a composite endpoint of acute exacerbation, hospitalization, or rapid disease progression, defined as a ≥10% relative decline in FVC over 3 months

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 to remote monitoring protocol, defined as the proportion of measurements completed >=67% of weeks with full data entry)

Primary: Participant retention at 12 months (target >=80%)

Data completeness, defined as >85% of expected remote monitoring data points successfully transmitted

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.

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.

Measured by comparing changes in FVC in home spirometry vs clinic-based spirometry

Measured by FVC values collected through home spirometry.

Measured by collecting data on initiation, discontinuation, or dose adjustment of antifibrotic medication, immunosuppressive therapy, oxygen therapy, referral for transplant evaluation, or referral to pulmonary rehabilitation.

Patient engagement and activation, as measured by the Patient Activation Measure (PAM) which assess a patient's knowledge, skill, and confidence for self-managing their health. The 13 items are measured on a 4-point Likert scale, with the raw total transformed into a standardized score of 0-100 where higher scores indicate greater activation.

Patient-reported satisfaction, acceptability and burden of monitoring as measured by survey adapted from Home Monitoring Acceptance and Satisfaction Questionnaire (HoMASQ). The ten item questionnaire scores each item on a 1-5 Likert scale with the total score ranging from 10 to 50. A higher score means higher patient satisfaction.

Total cost of delivering the home monitoring intervention, calculated as the sum of intervention costs (per-unit cost of the home spirometer, pulse oximeter, and/or weight scale, plus electronic patient-reported outcome [ePRO] platform licensing and data transmission fees) and implementation costs (personnel time for device provisioning, patient training, technical support, and clinician review of transmitted data, valued using time-driven activity-based costing and applicable wage rates). Cost will be calculated per patient over the 12-month active monitoring period, in US dollars. Consistent with the factorial MOST design, total cost will be analyzed by main effect - oximeter (Arms 2 and 4 combined vs. Arms 1 and 3 combined) and weight scale (Arms 3 and 4 combined vs. Arms 1 and 2 combined).

Number of unscheduled clinical contacts or escalations triggered by remote monitoring