Fibrotic Interstitial Lung DiseaseRESPOND-ILDNCT07673237
Remote Evaluation and Surveillance of Patients With Interstitial Lung Disease: Transforming ILD Care Delivery With Remote Monitoring
A study testing Spirometer, Oximeter and Scale in people with Fibrotic Interstitial Lung Disease and IPF and PPF, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrotic Interstitial Lung Disease, IPF and PPF, Lung Fibrosis Interstitial
- What is being tested?
- Spirometer, Oximeter and Scale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who are unable provide informed consent for any reason or are acutely ill.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94117
Yeji Lee, 415-353-9744, Yeji.Lee@ucsf.edu
Erica D Farrand, MD
About this study
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.
Read the 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.
- Being tested
- Spirometer, Oximeter, Scale, ePROs (electronic patient reported outcomes)
- 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
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometerDevice
Home spirometry will be conducted weekly by completing a spirometry maneuver (inhaling and exhaling through the device mouthpiece).
OximeterDevice
Oxygen saturation levels will be measured daily using a pulse oximeter.
ScaleDevice
Weight will be measured weekly using a wireless scale provided by the study.
ePROs (electronic patient reported outcomes)Other
Brief electronic symptom questionnaires will be completed through a secure app which will be downloaded on participant's phone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Spirometer; Other: ePROs (electronic patient reported outcomes) |
| 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. Receives: Device: Spirometer; Device: Oximeter; Other: ePROs (electronic patient reported outcomes) |
| 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. Receives: Device: Spirometer; Device: Scale; Other: ePROs (electronic patient reported outcomes) |
| 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. Receives: Device: Spirometer; Device: Oximeter; Device: Scale; Other: ePROs (electronic patient reported outcomes) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, Month 12
Adherence
Adherence to remote monitoring protocol, defined as the proportion of measurements completed >=67% of weeks with full data entry)
Measured: 12 months
Retention
Primary: Participant retention at 12 months (target >=80%)
Measured: 12 months
Data Completeness
Data completeness, defined as >85% of expected remote monitoring data points successfully transmitted
Measured: 12 months
Secondary outcomes (9)
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.
Measured: Baseline, Month 12
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.
Measured: Baseline, Month 12
Change in FVC
Measured by comparing changes in FVC in home spirometry vs clinic-based spirometry
Measured: Baseline, Month 12
Proportion of patients with ≥10% decline in FVC
Measured by FVC values collected through home spirometry.
Measured: Baseline, Month 12
Proportion of patients with a change in ILD-related treatment
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.
Measured: Baseline, Month 12
Patient Engagement and Activation
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.
Measured: 12 months
Patient-reported Satisfaction
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.
Measured: 12 months
Total implementation cost of home monitoring intervention components (per-patient, US dollars)
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).
Measured: 12 month
Unintended Implementation Impact
Number of unscheduled clinical contacts or escalations triggered by remote monitoring
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fibrotic Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), patientMpower Ltd.
- Responsible party
- Principal investigator, Erica Farrand, MD, University of California, San Francisco
- Investigators
- Erica Farrand, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673237
- Sponsor's protocol ID
- 25-44428
- Other IDs
- 5K23HL175213-02
- Acronym
- RESPOND-ILD
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33590991Handley 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.
PubMed 29328873Russell 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.
PubMed 27089018Ku 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.
PubMed 33990671Ge 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.
PubMed 37611253Farrand 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.
PubMed 36943196Sim I. Mobile Devices and Health. N Engl J Med. 2019 Sep 5;381(10):956-968. doi: 10.1056/NEJMra1806949. No abstract available.
PubMed 31483966Odisho 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.
PubMed 37031033Wijsenbeek 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.
PubMed 36206780