Remote Evaluation and Surveillance of Patients With Interstitial Lung Disease: Transforming ILD Care Delivery With Remote Monitoring (RESPOND-ILD)
22. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
200
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Erica D Farrand, MD
- Telefonní číslo: 415-476-8067
- E-mail: Erica.Farrand@ucsf.edu
Studijní záloha kontaktů
- Jméno: Yeji Lee
- Telefonní číslo: 415-353-9744
- E-mail: Yeji.Lee@ucsf.edu
Studijní místa
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California
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San Francisco, California, Spojené státy, 94117
- University of California, San Francisco
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
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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.
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Experimentální: 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.
|
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.
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Experimentální: 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.
|
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.
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Experimentální: 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.
|
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Detection rate of clinically significant ILD events
Časové okno: Baseline, Month 12
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Measured using a composite endpoint of acute exacerbation, hospitalization, or rapid disease progression, defined as a ≥10% relative decline in FVC over 3 months
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Baseline, Month 12
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Time to detection of first ILD event
Časové okno: Baseline, Month 12
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Measured using a composite endpoint of acute exacerbation, hospitalization, or rapid disease progression, defined as a ≥10% relative decline in FVC over 3 months.
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Baseline, Month 12
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Adherence
Časové okno: 12 months
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Adherence to remote monitoring protocol, defined as the proportion of measurements completed >=67% of weeks with full data entry)
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12 months
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Retention
Časové okno: 12 months
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Primary: Participant retention at 12 months (target >=80%)
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12 months
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Data Completeness
Časové okno: 12 months
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Data completeness, defined as >85% of expected remote monitoring data points successfully transmitted
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12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in health-related quality of life
Časové okno: Baseline, Month 12
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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.
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Baseline, Month 12
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Change in health-related quality of life
Časové okno: Baseline, Month 12
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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.
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Baseline, Month 12
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Change in FVC
Časové okno: Baseline, Month 12
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Measured by comparing changes in FVC in home spirometry vs clinic-based spirometry
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Baseline, Month 12
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Proportion of patients with ≥10% decline in FVC
Časové okno: Baseline, Month 12
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Measured by FVC values collected through home spirometry.
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Baseline, Month 12
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Proportion of patients with a change in ILD-related treatment
Časové okno: Baseline, Month 12
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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.
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Baseline, Month 12
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Patient Engagement and Activation
Časové okno: 12 months
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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.
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12 months
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Patient-reported Satisfaction
Časové okno: 12 months
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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.
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12 months
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Total implementation cost of home monitoring intervention components (per-patient, US dollars)
Časové okno: 12 month
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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).
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12 month
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Unintended Implementation Impact
Časové okno: 12 month
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Number of unscheduled clinical contacts or escalations triggered by remote monitoring
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12 month
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Erica Farrand, MD, University of California, San Francisco
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Sim I. Mobile Devices and Health. N Engl J Med. 2019 Sep 5;381(10):956-968. doi: 10.1056/NEJMra1806949. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
1. srpna 2028
Dokončení studie (Odhadovaný)
1. srpna 2028
Termíny zápisu do studia
První předloženo
15. června 2026
První předloženo, které splnilo kritéria kontroly kvality
22. června 2026
První zveřejněno (Aktuální)
29. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
29. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
22. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 25-44428
- 5K23HL175213-02 (Grant/smlouva NIH USA)
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Plánujete sdílet data jednotlivých účastníků (IPD)?
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Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .