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Short-term Telehealth Follow up After Hospital Discharge for Chronic Obstructive Pulmonary Disease Exacerbation (RHCluster4GR)

21. februar 2015 opdateret af: Konstantinos Gourgoulianis, Regional Health Authority of Sterea & Thessaly

Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation

The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life. In addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care. Following this; it is also hypothesized that this will also lead to less patients' deaths. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

155

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Grækenland
    • Thessaly
      • Larisa, Thessaly, Grækenland, 41110
        • Pulmonary Department - Regional University Hospital of Larisa

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Exacerbation of COPD according to the GOLD guidelines
  • Age > 40 years
  • Capability to use the devices provided
  • Willing to participate

Exclusion Criteria:

included in previous COPD monitoring study

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Teleovervågning
Procedure: Telemonitoring
Within 24 hours after patient's discharge, the telemedicine equipment is installed at the patient's home and patients are trained in the use of the equipment. Patients are followed by a dedicated telehealth centre. Patients at home are asked to fill out each morning the CAT questionnaire and to record extra use of COPD relief medications. Patients in stable conditions perform telespirometry and teleoximetry at 4 and 12 weeks. When a clinical worsening is detected (increase in CAT score by 5 points or higher on two consecutive days) the patient is contacted and asked to perform ad hoc telespirometry and teleoximetry and to send the data to the telehealth centre.
Ingen indgriben: Usual care
Patients in the control group receive usual care and visit the outpatient department at 4 and at 12 weeks after discharge when pulse rate, oxygen saturation and spirometry is performed. In the case of clinical deterioration during the study, the patients contact as usual their general practitioner. Usual care of COPD patients consists of regular visits to the specialist or primary care clinics every time a medication change is made or a medical examination is needed

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of hospital readmissions
Tidsramme: 3 months period
Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation
3 months period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
Tidsramme: 3 months - at the entry point of the intervention and the end.
Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
3 months - at the entry point of the intervention and the end.
Hospital anxiety and depression scale HADS
Tidsramme: 3 months - at the entry point of the intervention and the end.
Hospital anxiety and depression scale HADS
3 months - at the entry point of the intervention and the end.
Health status, measured with the St. George's Respiratory Questionnaire SGRQ
Tidsramme: 3 months - at the entry point of the intervention and the end.
Health status, measured with the St. George's Respiratory Questionnaire SGRQ
3 months - at the entry point of the intervention and the end.
Lung condition as measured by FEV1
Tidsramme: 1 month after the hospital discharge.
Lung condition as measured by FEV1
1 month after the hospital discharge.
Mortality
Tidsramme: 3 months period
Mortality
3 months period
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
Tidsramme: at the 3rd month of the tele-monitoring
Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring)
at the 3rd month of the tele-monitoring

Samarbejdspartnere og efterforskere

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

Sponsor

Regional Health Authority of Sterea & Thessaly

Samarbejdspartnere

University of Thessaly
Alexander Technological Educational Institute, Thessaloniki, Greece
Institute of Communications and Computer Systems, Athens, Greece
Ministry for Health and Social Solidarity, Greece
Municipality of Trikala, Greece
Institute of Biomedical Research & Technology, Larissa, Greece
University of Macedonia, Thessaloniki, Greece
e-Trikala S.A.
Cities Net SA

Efterforskere

  • Ledende efterforsker: Konstantinos Gourgoulianis, MD, PhD, Pulmonary Department - University Hospital of Larisa

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.

Generelle publikationer

Hjælpsomme links

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

1. marts 2011

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først indsendt

6. december 2011

Først indsendt, der opfyldte QC-kriterier

7. december 2011

Først opslået (Skøn)

9. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. februar 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2015

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FR2017
  • EC Grant Agreement 250487 (Andet bevillings-/finansieringsnummer: European Commission CIP/PSP-ICT Grant Agreement 250487)

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 Telemonitoring

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner