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Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients (UTIR)

4. juni 2014 opdateret af: Michele Vitacca, Fondazione Salvatore Maugeri

Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit

Patients at high complexity with severe chronic diseases can require several admission in intensive care units (ICU) to overcome acute exacerbations by the use of assisted ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of patients often needing weaning procedures due to a long-lasting period of mechanical ventilation. These patients are often under chronic conditions with recurrent symptoms, reduced effort tolerance and depression.

Weaning process is a frail step in the medical history of a patient who has survived an acute episode of respiratory failure and has spent a period of time under mechanical ventilation. Patients are followed for the duration of in-hospital stay, an expected average period of 4 weeks.

When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is usually managed by GPs and by the hospital where he has been admitted to following re-exacerbations. The conventional approach is for sure inadequate for this type of patient whose clinical complexity, disability and frailty need for a continuity of care through a higher complex approach of management.

A structured program of Home Rehabilitation could be a possible solution to this problem. Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy of a home rehabilitative network for prolonged weaned patients discharged from a weaning unit.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Patients referred to the Fondazione Salvatore Maugeri for prolonged weaning are enrolled and trained in an individualised program of home care in order to recover their own autonomies. Home care compares 2 arms: usual care vs physiotherapist (PT)-assisted care. Usual care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance, periodical in-hospital visit. The PT-assisted home care is supported by PT at least 2 times/month, autonomous 50 min physical activity/working day by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. Few brief educational lessons by PT preceded the training activity. Every two weeks, PT calls the patient by phone for an educational reinforcement.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Italien
    • Brescia
      • Lumezzane, Brescia, Italien, 25065
        • Fondazione Salvatore Maugeri

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

  • General Inclusion criteria: 1. Signature of the informed 2. Good expectation of life
  • Specific Inclusion Criteria : Score of general dependences < 19 according to the Critical Patients Autonomy Planning (CPAP) Scale

Exclusion Criteria:

  • Patient with neuromuscular, highly progressive neurological diseases (i.e. amyotrophic lateral sclerosis), patient requiring surgical interventions, sedation, and hemodialysis.
  • Unstable patient conditions as daily variability of the blood arterial pressure >20%, arrhythmias, PaO2/FiO2 < 300, unsatisfactory respiratory pattern, haemoglobin < 7 g /dL, temperature > 38°C, presence of neurological or orthopaedic side effects, and recent embolisms from TVP. Refusal.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Usual home care
No assistance or care by PT.
Andet: Usual home care
Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
Eksperimentel: PT-assisted home rehabilitation
Assisted home care is supported by a PT at least 2 times/month. Few brief educational lessons preceeded the training activity that the patient performs by himself at home.
Adfærdsmæssigt: PT-assisted home rehabilitation

Patient performs 50 min physical activity/working day autonomously by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles.

Every two weeks, PT phones the patient for an educational reinforcement.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Critical Patients Autonomy Planning (CPAP)
Tidsramme: Changes from baseline and 4 weeks, and 6 months after home activity
CPAP is a measure of dependency. CPAP was evaluated at three different time-points: at in-hospital admission (baseline), at discharge (patients are followed for the duration of their in-hospital stay, an expected average time of 4 weeks), and after 6 months of physical activity at home.
Changes from baseline and 4 weeks, and 6 months after home activity

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Tidsramme: Changes from baseline and 4 weeks (average time), and 6 months after home activity
Respiratory Functionality
Changes from baseline and 4 weeks (average time), and 6 months after home activity
MRF 26
Tidsramme: Changes between discharge at 4 weeks (average time) and 6 months after home activity
Quality of life evaluation.
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Likert Scale
Tidsramme: Changes between discharge at 4 weeks (average time) and 6 months after home activity
Satisfaction for patient/caregiver
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Mortality
Tidsramme: Changes between 3, 6 and 12 months post-discharge
Clinical measure
Changes between 3, 6 and 12 months post-discharge
MRC Scale and/or dynamometer
Tidsramme: Changes between baseline, discharge at 4 weeks, and 6 months after home activity
Rehabilitative measure referring to muscles force
Changes between baseline, discharge at 4 weeks, and 6 months after home activity
6-min walking test
Tidsramme: Changes from baseline and discharge at 4 weeks, and 6 months after home activity
Rehabilitative measure evaluating the effort tolerance.
Changes from baseline and discharge at 4 weeks, and 6 months after home activity
EuroQol
Tidsramme: Changes between discharge at 4 weeks (average time) and 6 months after home activity
Quality of life evaluation
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Gussago Nursing Scale
Tidsramme: Changes from baseline and 4 weeks, and 6 months after home activity
Measure of dependency.
Changes from baseline and 4 weeks, and 6 months after home activity
Barthel Index
Tidsramme: Changes from baseline and 4 weeks, and 6 months after home activity
Measure of dependency.
Changes from baseline and 4 weeks, and 6 months after home activity
Pre-morbidity life-style (PLS)
Tidsramme: Changes from baseline and 4 weeks, and 6 months after home activity
Measure of dependency.
Changes from baseline and 4 weeks, and 6 months after home activity

Samarbejdspartnere og efterforskere

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

Sponsor

Fondazione Salvatore Maugeri

Efterforskere

  • Ledende efterforsker: Piero Ceriana, MD, Fondazione Salvatore Maugeri
  • Studieleder: Michele Vitacca, MD, Fondazione Salvatore Maugeri

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

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. juli 2011

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

10. april 2012

Først indsendt, der opfyldte QC-kriterier

13. april 2012

Først opslået (Skøn)

16. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UTIR
  • Dlg. 5685 on 28 May 2010 (Andet bevillings-/finansieringsnummer: Lombardy Region)

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