Telemedicine for Patients With Chronic Respiratory Insufficiency
Randomised Trial on Telemedicine to Save Health Care Requests for Patients With Severe Chronic Respiratory Failure.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background: Integrated care and strict follow up have been recommended for frail patients with chronic respiratory failure (CRF) discharged at home.
Objectives: To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged at home with oxygen and/or home mechanical ventilation (HMV) with a high risk of hospital readmission.
Design: Prospective randomised controlled trial. Setting: Respiratory Rehabilitation Unit S. Maugeri Foundation between May 2004 and March 2007.
Participants: 240 CRF patients will be randomised into an intervention group (TM) and a control Group, which received current usual care (educational plan, 3 months outpatient visits).
Interventions: one year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing.
Main outcome measures: survival, admissions to emergency room (ER), hospitalisations, urgent general practitioner (GP) calls, home relapses; probability to remain free from the above events will be also compared among groups. TM and health Care System costs as customer satisfaction will be also collected.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Brescia
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Lumezzane, Brescia, Italien, 25065
- Telemedicine Service, Fondazione S. Maugeri, IRCCS
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- CRF patients discharged from Respiratory Unit with home MV
Exclusion Criteria:
- Severe co morbid conditions, i.e. lung cancer or other advanced malignancies, and extremely severe neurological disorders (with impaired cognitive status, ability to understand medical instructions, dementia or severe psychiatric illness)
- Logistical limitations due to extremely poor social conditions, such as illiteracy or no telephone access at home
- Being admitted to a nursing home
- Lack of caregiver when ventilated invasively (i.e. tracheal cannula with sounds uncertain) to allow a contact between care team and family
- Refusal to give informed consent
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Telemedicine
Patients were submitted to a Telemedicine program for 1 year
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One year TM with continuous (h 24) on call accessibility to a nurse and/or a pulmonologist, a web-based call centre and a pulse oxymetry tracing will be provided.
Andre navne:
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Ingen indgriben: Control group
Patients were submitted to usual care (i.e: educational plan and outpatient visits every 3 months)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To evaluate impact and costs on health care resources of a telemedicine programme (TM) for severe patients discharged with oxygen and/or home mechanical ventilation (HMV) with high risk of hospital readmission.
Tidsramme: 3 years
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3 years
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michele Vitacca, MD, Fondazione S. Maugeri IRCCS
Publikationer og nyttige links
Generelle publikationer
- Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.
- Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
- Adams SG, Smith PK, Allan PF, Anzueto A, Pugh JA, Cornell JE. Systematic review of the chronic care model in chronic obstructive pulmonary disease prevention and management. Arch Intern Med. 2007 Mar 26;167(6):551-61. doi: 10.1001/archinte.167.6.551.
- Vitacca M, Bianchi L, Guerra A, Fracchia C, Spanevello A, Balbi B, Scalvini S. Tele-assistance in chronic respiratory failure patients: a randomised clinical trial. Eur Respir J. 2009 Feb;33(2):411-8. doi: 10.1183/09031936.00005608. Epub 2008 Sep 17.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- N°158
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