- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01769742
Early Mobility Bundle to Prevent Hospital Acquired Pneumonia (HAP) in Medical Inpatients
Use of Early Mobilisation to Reduce Incidence of Hospital Acquired Pneumonia in Medical Inpatients
Hospital acquired pneumonia (HAP) is a common complication of extended hospital stay. In surgical specialities and critical care early physiotherapy is a recognised way of preventing such infections, and reducing length of hospital stay (LOS), however prevention of this problem is less well studied in medical inpatients.
The investigators propose a pilot study to assess the impact of introducing an early mobilisation strategy to general medical and respiratory wards at an acute Trust in the United Kingdom (UK). The investigators will recruit all new admissions to each of 2 respiratory and 2 elderly care wards - 1 of each ward type will be allocated to receive extra physiotherapy input targeting new admissions for early mobilisation. Patients' usual mobility, current mobility and actual activity levels will be studied by accelerometer and simple patient questionnaire in the first 48 hours of admission, and compared between groups. Incidence of HAP and total LOS will be recorded and compared between groups.
The investigators hypotheses are that the physiotherapy intervention will increase activity levels, reduce incidence of HAP and reduce LOS. The latter may result in cost savings to the National Health Service (NHS), which the investigators will model using local tariff data.
The investigators plan to use our data to power a larger randomised controlled study, or if the intervention is a marked success, such that a control group would be unethical, then a wider service development and evaluation programme.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
West Midlands
-
Birmingham, West Midlands, Det Forenede Kongerige, B9 5SS
- Heart of England NHS Trust
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Any medical inpatient
Exclusion Criteria:
- Nil for main study
- Immobile patients and those unable to consent will be excluded from the sub-study using activity reporting and monitoring by Actigraph
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Early mobility bundle
Delivery of early targeted physiotherapy to patients on the interventional wards; to comprise assessment and communication of mobility to ward staff and patient, provision of mobility aids, guidance and encouragement to patient and staff to allow patient to dress and mobilise independently if clinically safe to do so
|
|
|
Ingen indgriben: Usual care
Usual physiotherapy service only
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of hospital acquired pneumonia
Tidsramme: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured, and expressed as incidence/week of stay.
Patients whose length of stay is lower or higher than average will not be excluded.
|
Duration of hospital stay (up to 12 days)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of hospital stay in days
Tidsramme: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
|
Incidence of falls
Tidsramme: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
|
Incidence of pressure area problems
Tidsramme: Duration of hospital stay (up to 12 days)
|
The average length of stay is 8 days on the respiratory ward and 12 days on elderly care.
This is the time period in which incidence of hospital acquired pneumonia will be measured.
Patients whose length of stay is lower or higher than average will not be excluded
|
Duration of hospital stay (up to 12 days)
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Activity levels as reported by patient
Tidsramme: Days 1 and 2 of admission to ward
|
Days 1 and 2 of admission to ward
|
|
Activity levels as measured by Actigraph
Tidsramme: Day 1 and 2 of admission to ward
|
Day 1 and 2 of admission to ward
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alice Turner, University of Birmingham
Publikationer og nyttige 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
- RG-12-237
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 Hospitalserhvervet lungebetændelse
-
BioVersys SASBioVersys AGRekrutteringHospital Acquired Bacterial Pneumonia (HABP) | Ventilator Associated Bacterial Pneumonia (VABP) | Acinetobacter Baumannii-calcoaceticus kompleks | Colistin-resistent ABCGeorgien
-
ShionogiAfsluttetHospital Acquired Pneumonia (HAP) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Israel, Spanien, Forenede Stater, Belgien, Canada, Tjekkiet, Estland, Frankrig, Georgien, Tyskland, Ungarn, Japan, Letland, Filippinerne, Puerto Rico, Den Russiske Føderation, Serbien, Taiwan, Ukraine
-
Fondazione Policlinico Universitario Agostino Gemelli...Catholic University of the Sacred HeartRekrutteringVAP - Ventilator Associated Pneumonia | HAP - Hospital Acquired PneumoniaItalien
-
Capital Medical UniversityChina-Japan Friendship Hospital; Beijing Municipal Health CommissionIkke rekrutterer endnuCommunity Acquired Pneumonia (CAP)Kina
-
BioVersys AGIkke rekrutterer endnuMeningitis, bakteriel | Hospital Acquired Bacterial Pneumonia (HABP) | Ventilator Associated Bacterial Pneumonia (VABP) | Blodstrømsinfektion | Ventrikulitis, Infektiøs
-
University of Maryland, BaltimoreIkke rekrutterer endnuCommunity Acquired Pneumonia (CAP)Forenede Stater
-
Nantes University HospitalRekrutteringHospital Acquired Pneumonia (HAP) | Hjerte-kar- og luftvejssygdommeFrankrig
-
ShionogiAfsluttetSepsis | Blodbaneinfektioner (BSI) | Hospital Acquired Pneumonia (HAP) | Kompliceret urinvejsinfektion (cUTI) | Healthcare-associated Pneumonia (HCAP) | Ventilator Associated Pneumonia (VAP)Forenede Stater, Brasilien, Kroatien, Frankrig, Tyskland, Grækenland, Guatemala, Israel, Italien, Japan, Korea, Republikken, Spanien, Taiwan, Thailand, Kalkun, Det Forenede Kongerige
-
Sohag UniversityIkke rekrutterer endnuCommunity Acquired Pneumonia (CAP)
-
PfizerAfsluttetCommunity Acquired Pneumonia (CAP)Spanien
Kliniske forsøg med Early mobility bundle
-
Zimmer BiometTilmelding efter invitationLedsygdomme | Rheumatoid arthritis | Avaskulær nekrose | Lårhalsbrud | Hofteartrose | Dislokation, Hofte | Trochanteriske frakturer | RevisionsoperationerForenede Stater, Belgien, Korea, Republikken, Italien
-
Stryker Trauma GmbHAfsluttetNekrose af lårbenshovedet | Primær slidgigt | Medfødte dislokationer | Lårhalsbrud | Post-traumatisk slidgigt i hofte nr
-
Kepler University HospitalRekruttering
-
Zimmer BiometAktiv, ikke rekrutterendeKliniske resultater | Overlevelse | Sikkerhed | Funktionelle resultater | Radiologiske resultaterForenede Stater
-
Medacta International SAAktiv, ikke rekrutterende
-
Bader Faiyaz ZuberiAfsluttetKritisk sygdom | MoralPakistan
-
Kean UniversityAfsluttetSund og raskForenede Stater
-
US Department of Veterans AffairsAfsluttetRygmarvsskade | Spina Bifida | RygmarvssygdomForenede Stater
-
Smith & Nephew Medical (Shanghai) LtdAfsluttetHoftebrud | Hofteluksation | Lårhalsbrud | Slidgigt (OA) | Reumatoid arthritis (RA) | Degenerativ hofteledssygdom | Avaskulær nekrose af lårbenshovedetKina
-
Sunnybrook Health Sciences CentreSuspenderetPost traumatisk stress syndromCanada