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

NCT07673237 | Not Yet Recruiting DMC

• 2 other identifiers: 25-444285K23HL175213-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrotic Interstitial Lung Disease; IPF and PPF; Lung Fibrosis Interstitial

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

Outcome Measures

Primary Outcomes (5)

• 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

  Baseline, Month 12

• 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.

  Baseline, Month 12

• Adherence

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

  12 months

• Retention

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

  12 months

• Data Completeness

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

  12 months

Secondary Outcomes (9)

• Change in health-related quality of life

  Baseline, Month 12

• Change in health-related quality of life

  Baseline, Month 12

• Change in FVC

  Baseline, Month 12

• Proportion of patients with ≥10% decline in FVC

  Baseline, Month 12

• Proportion of patients with a change in ILD-related treatment

  Baseline, Month 12

Study Arms (4)

Spirometry Only

EXPERIMENTAL

Participants randomized to Arm 1 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece). Participants will also complete brief symptom questionnaires electronically throughout the study period.

Behavioral: Home Monitoring in Patients with f-ILD

Spirometer and Oximeter

EXPERIMENTAL

Participants randomized to Arm 2 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece) and will measure oxygen saturation levels daily using a pulse oximeter. Participants will also complete brief electronic symptom questionnaires throughout the study period.

Behavioral: Home Monitoring in Patients with f-ILD

Spirometer and Scale (weight)

EXPERIMENTAL

Participants randomized to Arm 3 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece) and will measure their weight weekly using the wireless scale provided by the study. Participants will also complete brief electronic symptom questionnaires throughout the study period.

Behavioral: Home Monitoring in Patients with f-ILD

Spirometer, Oximeter, and Scale (weight)

EXPERIMENTAL

Participants randomized to Arm 4 will perform home spirometry weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece), measure oxygen saturation levels daily using a pulse oximeter, and measure their weight weekly using the wireless scale provided by the study. Participants will also complete brief electronic symptom questionnaires throughout the study period.

Behavioral: Home Monitoring in Patients with f-ILD

Interventions

Home Monitoring in Patients with f-ILD BEHAVIORAL

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.

Spirometer and Oximeter; Spirometer and Scale (weight); Spirometer, Oximeter, and Scale (weight); Spirometry Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are unable provide informed consent for any reason or are acutely ill.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• patientMpower Ltd.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94117, United States

Location

Related Publications (9)

• Ilowite J, Lisker G, Greenberg H. Digital Health Technology and Telemedicine-Based Hospital and Home Programs in Pulmonary Medicine During the COVID-19 Pandemic. Am J Ther. 2021 Feb 3;28(2):e217-e223. doi: 10.1097/MJT.0000000000001342.

  PMID: 33590991 BACKGROUND

• Handley MA, Lyles CR, McCulloch C, Cattamanchi A. Selecting and Improving Quasi-Experimental Designs in Effectiveness and Implementation Research. Annu Rev Public Health. 2018 Apr 1;39:5-25. doi: 10.1146/annurev-publhealth-040617-014128. Epub 2018 Jan 12.

  PMID: 29328873 BACKGROUND

• Russell AM, Adamali H, Molyneaux PL, Lukey PT, Marshall RP, Renzoni EA, Wells AU, Maher TM. Daily Home Spirometry: An Effective Tool for Detecting Progression in Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2016 Oct 15;194(8):989-997. doi: 10.1164/rccm.201511-2152OC.

  PMID: 27089018 BACKGROUND

• Ku JP, Sim I. Mobile Health: making the leap to research and clinics. NPJ Digit Med. 2021 May 14;4(1):83. doi: 10.1038/s41746-021-00454-z.

  PMID: 33990671 BACKGROUND

• Ge J, Fontil V, Ackerman S, Pletcher MJ, Lai JC. Clinical decision support and electronic interventions to improve care quality in chronic liver diseases and cirrhosis. Hepatology. 2025 Apr 1;81(4):1353-1364. doi: 10.1097/HEP.0000000000000583. Epub 2023 Aug 23.

  PMID: 37611253 BACKGROUND

• Farrand E, Gologorskaya O, Mills H, Radhakrishnan L, Collard HR, Butte AJ. Machine-Learning Algorithm to Improve Cohort Identification in Interstitial Lung Disease. Am J Respir Crit Care Med. 2023 May 15;207(10):1398-1401. doi: 10.1164/rccm.202211-2092LE. No abstract available.

  PMID: 36943196 BACKGROUND

• Sim I. Mobile Devices and Health. N Engl J Med. 2019 Sep 5;381(10):956-968. doi: 10.1056/NEJMra1806949. No abstract available.

  PMID: 31483966 BACKGROUND

• Odisho AY, Liu AW, Maiorano AR, Bigazzi MOA, Medina E, Leard LE, Shah R, Venado A, Perez A, Golden J, Kleinhenz ME, Kolaitis NA, Maheshwari J, Trinh BN, Kukreja J, Greenland J, Calabrese D, Neinstein AB, Singer JP, Hays SR. Design and implementation of a digital health home spirometry intervention for remote monitoring of lung transplant function. J Heart Lung Transplant. 2023 Jun;42(6):828-837. doi: 10.1016/j.healun.2023.01.010. Epub 2023 Feb 2.

  PMID: 37031033 BACKGROUND

• Wijsenbeek MS, Moor CC, Johannson KA, Jackson PD, Khor YH, Kondoh Y, Rajan SK, Tabaj GC, Varela BE, van der Wal P, van Zyl-Smit RN, Kreuter M, Maher TM. Home monitoring in interstitial lung diseases. Lancet Respir Med. 2023 Jan;11(1):97-110. doi: 10.1016/S2213-2600(22)00228-4. Epub 2022 Oct 4.

  PMID: 36206780 BACKGROUND

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erica Farrand, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica D Farrand, MD

CONTACT

415-476-8067; Erica.Farrand@ucsf.edu

Yeji Lee

CONTACT

415-353-9744; Yeji.Lee@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)