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Remote Electronic Patient Monitoring in Gastrointestinal Cancer

10. november 2020 opdateret af: Joseph A. Greer, Ph.D., Massachusetts General Hospital
The goal of this research study is to evaluate a program that involves remote electronic monitoring of vital signs and symptoms of patients with gastrointestinal cancer who were recently hospitalized at Massachusetts General Hospital or presented to the oncology clinic for an unplanned, urgent visit.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients with gastrointestinal cancer often experience troublesome symptoms and side effects related to the cancer and its treatment. Unfortunately, patients commonly require hospital admission or urgent clinic visits to help manage uncontrolled symptoms. For this study, the investigators seek to determine if a program that entails remote electronic monitoring may improve the overall care experience of patients with gastrointestinal cancer who have urgent care needs.

The investigators are asking the participants to take part in this research study because the participants are currently hospitalized at Massachusetts General Hospital or recently presented to the oncology clinic for an urgent visit, and are receiving treatment at the Cancer Center. The goal of this study is to test a program that involves remote electronic monitoring of vital signs and patient-reported health outcomes. This study is a pilot study, and the investigators are evaluating the feasibility of delivering the program, the acceptability and satisfaction with the program, changes in the quality of life and symptoms of patients who receive the program, as well as the frequency of urgent hospital visits while the patient is in the program.

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 or older
  • Diagnosed with gastrointestinal cancer
  • Hospitalized at Massachusetts General Hospital (MGH) or presenting to the ambulatory MGH oncology clinic for an unplanned, urgent visit
  • Planning to receive outpatient care at the MGH Cancer Center
  • Ability to read and respond to questions in English

Exclusion Criteria:

  • Uncontrolled psychiatric illness or impaired cognition that would interfere with completing study procedures
  • Enrolled in hospice
  • Planning to be discharged to any location other than their home

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Remote Electronic Patient Monitoring
  • The Remote Electronic Patient Monitoring intervention will entail monitoring of vital sign data and patient reported assessments to address and manage any concerning issues identified.
  • The Remote Patient Monitoring system uses algorithms that can indicate when patient vitals and patient-reported outcomes have changed.
  • Automatic patient surveys are sent to the patient with results displayed on the clinician user interface (i.e., dashboard) on a computer located in the clinical area.
  • Qualitative interviews with patient participants and their oncology clinicians using a semi-structured interview guide will be conducted.
Enhed: Remote Electronic Patient Monitoring
The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Feasibility of Remote Electronic Patient Monitoring Intervention
Tidsramme: 4 weeks
The intervention will be deemed feasible if at least 50% (95% confidence interval +/- 13%) of patients agree to participate in the study and sign informed consent, and if participants wear the Remote Electronic Patient Monitoring device ≥ 50% (95% confidence interval +/- 13%) of the time within the two weeks following the baseline time point.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants completing self-reported symptom monitoring through the remote electronic monitoring device during study period
Tidsramme: 4 weeks
4 weeks
Proportion of participants completing vital sign monitoring through the remote electronic monitoring device during study period
Tidsramme: 4 weeks
4 weeks
Number of concerning issues identified per patient during study period
Tidsramme: 4 weeks
4 weeks
Number of intervention-triggered phone calls from clinicians required per patient as well as average duration of these calls during study period
Tidsramme: 4 weeks
4 weeks
Number of intervention-triggered emails generated to the primary oncology team during study period
Tidsramme: 4 weeks
4 weeks
Proportion of intervention-triggered events that are not clinically acted upon (i.e., no change in patient care based on an intervention trigger) during study period
Tidsramme: 4 weeks
4 weeks
Acceptability of Remote Electronic Patient Monitoring Intervention
Tidsramme: 4 weeks
Participant report of perceptions of the usefulness, effectiveness, and relevance of the intervention per acceptability ratings and qualitative interviews with patient participants and their clinicians.
4 weeks
Patient-Reported Quality of Life
Tidsramme: 2 weeks and 4 weeks
Change in patient-reported quality of life from baseline to 2 and 4 weeks per the Functional Assessment of Cancer Therapy-General
2 weeks and 4 weeks
Patient-Reported Symptoms
Tidsramme: 2 weeks and 4 weeks
Change in patient-reported symptoms from baseline to 2 and 4 weeks per the Edmonton Symptom Assessment System-revised
2 weeks and 4 weeks
Patient-Reported Depression and Anxiety Symptoms
Tidsramme: 2 weeks and 4 weeks
Change in patient-reported depression and anxiety symptoms from baseline to 2 and 4 weeks per the Patient Health Questionnaire-4
2 weeks and 4 weeks
Health Care Utilization
Tidsramme: 4 weeks
Number of urgent clinic visits, emergency department visits, and hospital admissions during study period
4 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Massachusetts General Hospital

Efterforskere

  • Ledende efterforsker: Joseph Greer, MD, Massachusetts General Hospital

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)

1. september 2020

Primær færdiggørelse (Faktiske)

9. september 2020

Studieafslutning (Faktiske)

9. september 2020

Datoer for studieregistrering

Først indsendt

22. juli 2019

Først indsendt, der opfyldte QC-kriterier

22. juli 2019

Først opslået (Faktiske)

24. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 19-329

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD-delingstidsramme

Data can be shared no earlier than 1 year following the date of publication

IPD-delingsadgangskriterier

BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med Gastrointestinal kræft

Kliniske forsøg med Remote Electronic Patient Monitoring

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