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Use of MonitorMe in COPD

10. august 2022 oppdatert av: University of Lincoln

Use of MonitorMe in COPD: a Mixed-methods Feasibility Study

MonitorMe is a telephone device intended for the non-critical monitoring of vital signs in a domestic environment with the ability to automatically transmit data to a remote location via basic telephone connectivity.

MonitorMe's low-cost, call automation and simple to use technology (i.e. based on the principles of an ordinary plug-in telephone) make it appropriate for a wide number of care pathways. It eliminates the need for a modem or broadband and avoids the challenges of less reliable smart phone technology. Typical use scenarios include remote monitoring of individual or multiple chronic disease states such as COPD to improve patient outcomes including prevention of emergency admissions.

There is growing interest in the use of home telemonitoring in COPD in order to facilitate the management of the increasing numbers of patients and pressures on the NHS. Despite the positive effects of telemonitoring in conditions such as heart failure, benefits remain unproven in COPD and further work is required before wide-scale use.

Furthermore, until now the evaluation of telecare and telehealth developments has focused mainly on effectiveness and efficiency, whereas their social, and ethical implications in particular, have not been explored in depth. We will also explore ethical issues related to the use of telehealth systems, from both the patients' and the healthcare professionals' perspective.

The current feasibility study is designed to assess the acceptability, usability and validity of MonitorMe within one of its intended purposes i.e. remote monitoring of individual or multiple chronic disease states such as COPD.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

13

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Lincoln, Storbritannia, LN6 7TS
        • University of Lincoln
      • Lincoln, Storbritannia
        • Lincolnshire Community Health Services NHS Trust

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 til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Patients

  • Adults diagnosed with any severity of COPD (according to British Thoracic Society criteria, i.e. >10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio <0.70 and FEV<80%)
  • Listed on referral lists or COPD registers within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG

Health care professionals

  • Involved in implementing the device within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG
  • Provide informed consent to participate in an interview

Exclusion Criteria:

Patients

  • Inability or unwillingness to sign informed consent
  • No active telephone line in home
  • COPD exacerbation within the previous 6 weeks.
  • Mental health, cognitive or neurological conditions that would make study participation inappropriate
  • Life expectancy < 6 months
  • Implanted pacemaker
  • Hearing or visual ailments that would preclude the use of the MonitorMe device
  • Inability to use both hands (i.e. hold handset in one hand and use keypad with the other at same time)
  • Inability to understand verbal English

Health care professionals

  • Not involved in implementing the device within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG
  • Unable/unwilling informed consent to participate in an interview

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Intervention
MonitorMe device
MonitorMe replaces the users existing telephone and for the majority of time is used as their ordinary telephone. At a known and set time of day for 4 weeks, participants will receive an automated MonitorMe telephone call. The participant answers a health and well-being automated script by pressing key pad numbers. At the same time vital signs data are collected. The responses and vital signs data, together with confidence values are then transmitted via telephone lines to an electronic patient record.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Oxygen Saturation
Tidsramme: Day 0 to 28
Agreement between measurements made by MonitorMe and healthcare professionals
Day 0 to 28

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Temperature
Tidsramme: Day 0 to 28
Agreement between measurements made by MonitorMe and healthcare professionals
Day 0 to 28
Heart rate/pulse rate
Tidsramme: Day 0 to 28
Agreement between measurements made by MonitorMe and healthcare professionals
Day 0 to 28
Adverse event rate
Tidsramme: Day 0 to 28
Number of reported adverse events during study period
Day 0 to 28
Patient compliance
Tidsramme: Day 0 to 28
Number of MonitorMe automated calls completed during observation period
Day 0 to 28
Usability
Tidsramme: Day 0 to 28
Number of unsuccessful data transmissions or missing data (confidence values of MonitorMe)
Day 0 to 28
Acceptance/experience of MonitorMe for patients
Tidsramme: Day 28 to 84
Semi-structured interviews
Day 28 to 84
Acceptance/experience of MonitorMe for health care professionals
Tidsramme: Day 28 to 84
Semi-structured interviews
Day 28 to 84
Self-reported disease specific assessment of quality of life
Tidsramme: Day 0 and Day 28
Chronic Respiratory Questionnaire
Day 0 and Day 28
Recruitment rates
Tidsramme: 1 year
Time taken to achieve planned sample size
1 year
Consent rate
Tidsramme: 1 year
Number of eligible patients willing to consent to take part in the study
1 year
Retention rate
Tidsramme: Day 0 to 28
Number of patients who complete the study
Day 0 to 28

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Aloysius N Siriwardena, MBBS, PhD, University of Lincoln

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)

11. februar 2020

Primær fullføring (Forventet)

31. oktober 2022

Studiet fullført (Forventet)

31. desember 2022

Datoer for studieregistrering

Først innsendt

3. september 2019

Først innsendt som oppfylte QC-kriteriene

26. september 2019

Først lagt ut (Faktiske)

27. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. august 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2022

Sist bekreftet

1. mai 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 181003

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

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