Remote Evaluation and Surveillance of Patients With Interstitial Lung Disease: Transforming ILD Care Delivery With Remote Monitoring (RESPOND-ILD)
2026년 6월 22일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Erica D Farrand, MD
- 전화번호: 415-476-8067
- 이메일: Erica.Farrand@ucsf.edu
연구 연락처 백업
- 이름: Yeji Lee
- 전화번호: 415-353-9744
- 이메일: Yeji.Lee@ucsf.edu
연구 장소
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California
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San Francisco, California, 미국, 94117
- University of California, San Francisco
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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.
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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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실험적: 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.
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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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실험적: 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.
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Detection rate of clinically significant ILD events
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in health-related quality of life
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Erica Farrand, MD, University of California, San Francisco
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 1일
기본 완료 (추정된)
2028년 8월 1일
연구 완료 (추정된)
2028년 8월 1일
연구 등록 날짜
최초 제출
2026년 6월 15일
QC 기준을 충족하는 최초 제출
2026년 6월 22일
처음 게시됨 (실제)
2026년 6월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 22일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 25-44428
- 5K23HL175213-02 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .