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

June 22, 2026 updated by: Erica Farrand, MD, University of California, San Francisco
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94117
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spirometry Only
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
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.
Experimental: Spirometer and Oximeter
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
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.
Experimental: Spirometer and Scale (weight)
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
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.
Experimental: Spirometer, Oximeter, and Scale (weight)
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Detection rate of clinically significant ILD events
Time Frame: 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
Baseline, Month 12
Time to detection of first ILD event
Time Frame: 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.
Baseline, Month 12
Adherence
Time Frame: 12 months
Adherence to remote monitoring protocol, defined as the proportion of measurements completed >=67% of weeks with full data entry)
12 months
Retention
Time Frame: 12 months
Primary: Participant retention at 12 months (target >=80%)
12 months
Data Completeness
Time Frame: 12 months
Data completeness, defined as >85% of expected remote monitoring data points successfully transmitted
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in health-related quality of life
Time Frame: 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.
Baseline, Month 12
Change in health-related quality of life
Time Frame: Baseline, Month 12
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.
Baseline, Month 12
Change in FVC
Time Frame: Baseline, Month 12
Measured by comparing changes in FVC in home spirometry vs clinic-based spirometry
Baseline, Month 12
Proportion of patients with ≥10% decline in FVC
Time Frame: Baseline, Month 12
Measured by FVC values collected through home spirometry.
Baseline, Month 12
Proportion of patients with a change in ILD-related treatment
Time Frame: 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.
Baseline, Month 12
Patient Engagement and Activation
Time Frame: 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.
12 months
Patient-reported Satisfaction
Time Frame: 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.
12 months
Total implementation cost of home monitoring intervention components (per-patient, US dollars)
Time Frame: 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).
12 month
Unintended Implementation Impact
Time Frame: 12 month
Number of unscheduled clinical contacts or escalations triggered by remote monitoring
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
patientMpower Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erica Farrand, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-44428
  • 5K23HL175213-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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