- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01285869
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia (IMIEPAP)
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia: a Prospective Randomized Controlled Trial.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Barcelona, Spanien, 08025
- Hospital de la Santa Creu i Sant Pau
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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:
- Elderly patients (aged 65 years and over), of either sex, not dependent for basic activities of daily living (Barthel index ≥60 points).
- Diagnosed with community-acquired pneumonia at the Emergency Department or Day Hospitals at "Hospital de la Santa Creu I Santa Pau"
- Admitted to hospital.
Exclusion Criteria:
- Derived from other acute care hospitals.
- Patients with HIV infection.
- Neutrophil counter<1000/mm3
- Transplanted patients.
- Barthel index<60 points.
- Terminal disease.
- No signed informed consent.
Studieplan
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 |
|---|---|
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Eksperimentel: Multidisciplinar intervention
Patients that will receive the multidimensional intervention during the ambulatory follow-up.
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The patient will be cited 2 months after hospital discharge for a geriatric evaluation carried out by a geriatric nurse and an internist with geriatric training.
The duration of the first visit is 45-60 minutes.
The visit consists of: 1. Assessment of the pneumonia resolution, co-morbidities, aspiration risk, risk of multiresistant infections, and the immunization, functional and cognitive status.
2.
An individualized intervention plan.
The patient and family or caregiver will receive an educational intervention, a written report with the planned intervention and an educational leaflet.
Those patients who require further assessment or follow up of the intervention will receive 1 or 2 more visits and all the patients will be cited one year after the first visit.
Andre navne:
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Ingen indgriben: Conventional follow up
This is an observation only group and outpatient follow up will be indicated in accordance with usual and customary practices.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Healthcare resources utilization (readmissions and consultations to hospital and emergency department).
Tidsramme: 1 year after hospital admission for pneumonia
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To achieve the variables related to the healthcare resource utilization, computarized medical records will be reviewed and all patients will be followed up by telephone interview one year after discharge.The cause for readmission will be recorded.
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1 year after hospital admission for pneumonia
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional status
Tidsramme: 1 year after hospital admission for pneumonia
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Data will be obtained by review of medical records and telephone interview one year after discharge. Dependency in basic activities of daily living will be scored using the Barthel Index (Mahoney & Barthel. Maryland State Med J 14; 61-65) which measures the capacity to perform ten basic activities and gives a quantitative estimation of the patient level of dependency, scoring to 0 (totally dependent) to 100 (totally independent). |
1 year after hospital admission for pneumonia
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Institutionalization
Tidsramme: 1 year after hospital admission for pneumonia
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Data will be obtained by review of medical records and telephone interview one year after discharge.
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1 year after hospital admission for pneumonia
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Survival
Tidsramme: 1 year after hospital admission for pneumonia
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Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.
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1 year after hospital admission for pneumonia
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Olga H Torres, Phd, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Studiestol: Domingo Ruiz, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIBSP-INT-2010-13
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