eRT Remote Health Monitoring
29. april 2020 oppdatert av: Christopher B Cooper, MD, University of California, Los Angeles
Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).
Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
17
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Los Angeles, California, Forente stater, 90095
- UCLA David Geffen School of Medicine
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age >40 years.
- Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9
- Smoking history >10 pack-years.
- Postbronchodilator FEV1/FVC<70% and FEV1<70% based on NHANES III reference values
- Domestic situation felt to be supportive of remote health monitoring.
- Ability to give informed consent.
Exclusion Criteria:
- Clinical diagnosis of asthma.
- Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction.
- Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke).
- Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit.
- Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial.
- Myocardial infarction within 6 weeks of enrolment.
- Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day.
- A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Remote Health Monitoring
Subjects assigned to this arm will conduct daily at-home health monitoring using several electronic devices that will transmit data back to the study team.
Everyday, subjects will measure pulse oximetry (SpO2) using a finger clip, answer questions about symptoms and medication use, answer a quality of life questionnaire, perform breathing tests, and record physical activity (using a physical activity monitor that will be mailed to the study team).
Wearing the activity monitor is optional and will only occur during months 1, 6, and 12.
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1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Compliance with daily RHM
Tidsramme: 1 year
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Compliance with daily RHM as a percentage of study days
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1 year
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Integrity of spirometric data
Tidsramme: 1 year
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Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.
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1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Antall legebesøk
Tidsramme: 1 år
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1 år
|
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Rate of adoption of RHM
Tidsramme: 1 year
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Time it takes for subjects to become compliant with daily RHM
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1 year
|
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Treatment adherence
Tidsramme: 1 year
|
Treatment adherence in terms of percentage of days prescribed treatment* is taken (* treatment separate from study, prescribed by personal physician)
|
1 year
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Time to first COPD exacerbation
Tidsramme: 1 year
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Time to first COPD exacerbation as defined by standard criteria.
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1 year
|
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Number of COPD exacerbations per year
Tidsramme: 1 year
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1 year
|
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Proportion of subjects experiencing one or more exacerbations
Tidsramme: 1 year
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1 year
|
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Mean daily FEV1
Tidsramme: 1 year
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1 year
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Mean daily IC
Tidsramme: 1 year
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1 year
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Mean daily activity level
Tidsramme: 1 year
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1 year
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Mean daily SpO2
Tidsramme: 1 year
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1 year
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Daily symptom scores
Tidsramme: 1 year
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1 year
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Number of emergency department visits
Tidsramme: 1 year
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1 year
|
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Number of hospitalizations
Tidsramme: 1 year
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1 year
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Number of days spent in hospital
Tidsramme: 1 year
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1 year
|
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Health care costs
Tidsramme: 1 year
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Inferred health care costs using a standard cost framework model
|
1 year
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Samarbeidspartnere og etterforskere
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Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2012
Primær fullføring (Faktiske)
20. august 2014
Studiet fullført (Faktiske)
20. august 2014
Datoer for studieregistrering
Først innsendt
16. desember 2011
Først innsendt som oppfylte QC-kriteriene
16. desember 2011
Først lagt ut (Anslag)
20. desember 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mai 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. april 2020
Sist bekreftet
1. april 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- eRT RHM
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .