- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04306783
In-Home Sensor Monitoring of Older Adults With Cancer
14. september 2020 opdateret af: Washington University School of Medicine
In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
The investigators propose a pilot study of monitoring a sample of 6 older patients receiving active cancer treatment over a period of 6 months with in-home sensor monitors installed and maintained by Foresite Healthcare.
The investigators also propose exploring the beliefs and attitudes of those who are not willing to allow in-home sensor monitoring by asking them to complete a brief survey related to in-home sensor monitoring.
The investigators hypothesize that patients will find the equipment acceptable and unintrusive, that changes in home-monitored patient parameters will precede clinical events and that patient trajectories will be more fully characterized with the in home sensors.
Studieoversigt
Undersøgelsestype
Interventionel
Fase
- Ikke anvendelig
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
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Arm A:
- Age ≥ 65
- Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
- Estimated life expectancy >1 year
- Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- Willing to have sensors installed in 1-2 primary living areas (e.g. living room and bedroom)
- Continuous home internet connection
- Able to understand and willing to sign an IRB-approved written informed consent document
Arm B:
- Age ≥ 65
- Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
- Estimated life expectancy >1 year
- Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- Able to understand and willing to sign an IRB-approved written informed consent document
Exclusion Criteria:
Arm A:
- Inability to read and understand English
- Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
- Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff
Arm B:
- Inability to read and understand English
- Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
- Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arm A: In-Home Sensor Monitoring
Older adults with cancer undergoing systemic cancer treatment will undergo passive monitoring with motion sensors and bed sensor.
Passive infrared (PIR) motion sensors will be installed in their homes to detect presence in a particular room (e.g., bathroom or kitchen) as well as for specific activities.
There will also be a bed sensor, which is a pneumatic strip installed under the bed linens, which measures displacement of the resident's upper torso as he or she lies on the bed.
Participants will complete a baseline primarily self-administered survey, an abbreviated assessment with each follow up clinic visit (at least once per month) for 6 months of follow up and a final end of study assessment.
|
-Installed and maintained by Foresite Healthcare
|
Ingen indgriben: Arm B: Survey Only
Patients that choose to not proceed with in-home sensor monitoring will be asked to complete a brief survey that explores attitudes regarding in-home sensor monitoring
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Acceptability of in-home sensor monitoring as measured by a modified version of the Intelligent Systems for Assessment of Aging Technology Survey (Arm A only)
Tidsramme: 6 months
|
|
6 months
|
Heart rate (Arm A only)
Tidsramme: 6 months
|
-A meaningful change is heart rate outside the normal range of 60-100
|
6 months
|
Changes in gait speed of .1m/s or more (Arm A only)
Tidsramme: 6 months
|
6 months
|
|
Stride length (Arm A only)
Tidsramme: 6 months
|
6 months
|
|
Number of Falls (Arm A only)
Tidsramme: 6 months
|
6 months
|
|
Number of Hospitalizations (Arm A only)
Tidsramme: 6 months
|
6 months
|
|
Number of Emergency room visits (Arm A only)
Tidsramme: 6 months
|
6 months
|
|
Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only)
Tidsramme: 6 months
|
6 months
|
|
Number of grade ≥3 adverse events measured by CTCAE (Arm A only)
Tidsramme: 6 months
|
6 months
|
|
Patient reported outcomes of 10 common symptoms (Arm A)
Tidsramme: 6 months
|
|
6 months
|
Reason for not choosing in-home monitoring as measured by a modified version of the Intelligent Systems for Assessment of Aging Changes Technology Survey (Arm B only)
Tidsramme: At the time of invitation to participate in the study (Day 1)
|
|
At the time of invitation to participate in the study (Day 1)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tanya M Wildes, M.D., MSCI, Washington University School of Medicine
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.
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 (Forventet)
31. oktober 2020
Primær færdiggørelse (Forventet)
30. april 2022
Studieafslutning (Forventet)
30. april 2022
Datoer for studieregistrering
Først indsendt
5. november 2019
Først indsendt, der opfyldte QC-kriterier
9. marts 2020
Først opslået (Faktiske)
13. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 202001189
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med In-home sensor monitoring
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Starkey Laboratories, IncClinimark, LLCTrukket tilbage
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Biotronik Japan, Inc.Afsluttet
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Stanford UniversityLeaf Healthcare, Inc.AfsluttetTryksårForenede Stater