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

22. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94117
        • University of California, San Francisco

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Detection rate of clinically significant ILD events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months
Adherence to remote monitoring protocol, defined as the proportion of measurements completed >=67% of weeks with full data entry)
12 months
Retention
Tidsramme: 12 months
Primary: Participant retention at 12 months (target >=80%)
12 months
Data Completeness
Tidsramme: 12 months
Data completeness, defined as >85% of expected remote monitoring data points successfully transmitted
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in health-related quality of life
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Month 12
Measured by FVC values collected through home spirometry.
Baseline, Month 12
Proportion of patients with a change in ILD-related treatment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 12 month
Number of unscheduled clinical contacts or escalations triggered by remote monitoring
12 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Francisco

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)
patientMpower Ltd.

Efterforskere

  • Ledende efterforsker: Erica Farrand, MD, University of California, San Francisco

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

29. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25-44428
  • 5K23HL175213-02 (U.S. NIH-bevilling/kontrakt)

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