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Use of MonitorMe in COPD

10. august 2022 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Lincoln, Det Forenede Kongerige, LN6 7TS
        • University of Lincoln
      • Lincoln, Det Forenede Kongerige
        • Lincolnshire Community Health Services NHS Trust

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

40 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Aloysius N Siriwardena, MBBS, PhD, University of Lincoln

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 (Faktiske)

11. februar 2020

Primær færdiggørelse (Forventet)

31. oktober 2022

Studieafslutning (Forventet)

31. december 2022

Datoer for studieregistrering

Først indsendt

3. september 2019

Først indsendt, der opfyldte QC-kriterier

26. september 2019

Først opslået (Faktiske)

27. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. august 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 181003

Plan for individuelle deltagerdata (IPD)

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