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Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia (IMIEPAP)

This study is currently recruiting participants.

Verified January 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Sponsor:

Information provided by:

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

ClinicalTrials.gov Identifier:

NCT01285869

First received: January 27, 2011

Last updated: NA

Last verified: January 2011

History: No changes posted

Purpose

The hypothesis of this study is that long-term outcome in elderly patients admitted with the diagnosis of community-acquired pneumonia (CAP) or healthcare-associated pneumonia (HCAP) would improve with a multidimensional intervention including assessment of co-morbidities, nutritional, functional and cognitive status and immunization.

Condition	Intervention
Community Acquired Pneumonia Healthcare-Associated Pneumonia	Other: Multidimensional intervention

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia: a Prospective Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:

Healthcare resources utilization (readmissions and consultations to hospital and emergency department). [ Time Frame: 1 year after hospital admission for pneumonia ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Functional status [ Time Frame: 1 year after hospital admission for pneumonia ] [ Designated as safety issue: No ]
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).
Institutionalization [ Time Frame: 1 year after hospital admission for pneumonia ] [ Designated as safety issue: No ]
Data will be obtained by review of medical records and telephone interview one year after discharge.
Survival [ Time Frame: 1 year after hospital admission for pneumonia ] [ Designated as safety issue: No ]
Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.

Estimated Enrollment:	314
Study Start Date:	November 2010
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Multidisciplinar intervention Patients that will receive the multidimensional intervention during the ambulatory follow-up.	Other: Multidimensional intervention 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. Other Name: Comprehensive geriatric assesment
No Intervention: Conventional follow up This is an observation only group and outpatient follow up will be indicated in accordance with usual and customary practices.

Arms

Assigned Interventions

Experimental: Multidisciplinar intervention

Patients that will receive the multidimensional intervention during the ambulatory follow-up.

Other: Multidimensional intervention

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.

Other Name: Comprehensive geriatric assesment

No Intervention: Conventional follow up

This is an observation only group and outpatient follow up will be indicated in accordance with usual and customary practices.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285869

Contacts

Contact: Olga H Torres, Phd	932919000 ext 5609	otorres@santpau.cat
Contact: Domingo Ruiz, MD	932919000 ext 5609	druiz@santpau.cat

Locations

Spain
Hospital de la Santa Creu i Sant Pau	Recruiting
Barcelona, Spain, 08025
Principal Investigator: Olga H Torres, Phd

Sponsors and Collaborators

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Investigators

Principal Investigator:	Olga H Torres, Phd	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Chair:	Domingo Ruiz, MD	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

More Information

No publications provided

Responsible Party:	Olga H Torres, Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:	NCT01285869 History of Changes
Other Study ID Numbers:	IIBSP-INT-2010-13
Study First Received:	January 27, 2011
Last Updated:	January 27, 2011
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Pneumonia
Intervention Studies
Aged
Aged, 80 and over
Geriatric Assessment

Additional relevant MeSH terms:

Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 21, 2013

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