Fibrotic Interstitial Lung Disease, IPF and PPF, Lung Fibrosis Interstitial
Conditions
Keywords
Interstitial lung disease, pulmonary fibrosis, idiopathic pulmonary fibrosis, progressive pulmonary fibrosis, Remote patient monitoring, Digital health, Telemonitoring, Home monitoring, Pragmatic study design, Real-world monitoring, Decentralized clinical trial
Brief summary
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.
Detailed description
Participants in this 12-month study will use home-based monitoring tools provided by the study and complete electronic patient-reported outcome (ePRO) questionnaires to help assess changes in health status over time. Study procedures include weekly home spirometry for all participants, with some participants also asked to complete daily pulse oximetry monitoring and/or weekly weight measurements, depending on study assignment. The study includes an initial in-person baseline visit and a final in-person visit at Month 12 at the UCSF Interstitial Lung Disease Clinic at the Parnassus Campus. Follow-up study visits at Months 3, 6, and 9 will be conducted remotely via Zoom. Participants will complete study-related assessments throughout the study period using electronic devices and questionnaires from home.
Interventions
BEHAVIORALHome Monitoring in Patients with f-ILD
Participants will be expected to engage in home monitoring using study-provided devices, including a spirometer, pulse oximeter, and/or wireless scale, all of which will be connected to a secure application on the participant's mobile phone for remote data collection and transmission. Participants will also be expected to adhere to scheduled study visits and complete required study activities throughout the study period.
Sponsors
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI)
patientMpower Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18 or older * English or Spanish 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.
Exclusion criteria
* Patients who are unable provide informed consent for any reason or are acutely ill.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of clinically significant ILD events | Baseline, Month 12 | 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 | Baseline, Month 12 | 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 | 12 months | Adherence to remote monitoring protocol, defined as the proportion of measurements completed \>=67% of weeks with full data entry) |
| Retention | 12 months | Primary: Participant retention at 12 months (target \>=80%) |
| Data Completeness | 12 months | Data completeness, defined as \>85% of expected remote monitoring data points successfully transmitted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in health-related quality of life | Baseline, Month 12 | 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 FVC | Baseline, Month 12 | Measured by comparing changes in FVC in home spirometry vs clinic-based spirometry |
| Proportion of patients with ≥10% decline in FVC | Baseline, Month 12 | Measured by FVC values collected through home spirometry. |
| Proportion of patients with a change in ILD-related treatment | Baseline, Month 12 | 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 | 12 months | 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 | 12 months | 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 implementation cost of home monitoring intervention components (per-patient, US dollars) | 12 month | 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). |
| Unintended Implementation Impact | 12 month | Number of unscheduled clinical contacts or escalations triggered by remote monitoring |
Countries
United States
Contacts
CONTACTErica D Farrand, MD
CONTACTYeji Lee
PRINCIPAL_INVESTIGATORErica Farrand, MD
University of California, San Francisco
Outcome results
None listed