NCT01285869

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

7.6 years

First QC Date

January 27, 2011

Last Update Submit

February 24, 2019

Conditions

Community-acquired PneumoniaHealthcare-associated Pneumonia

Keywords

PneumoniaIntervention StudiesAgedAged, 80 and overGeriatric Assessment

Outcome Measures

Primary Outcomes (1)

  • Healthcare resources utilization (readmissions and consultations to hospital and emergency department).

    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.

    1 year after hospital admission for pneumonia

Secondary Outcomes (3)

  • Functional status

    1 year after hospital admission for pneumonia

  • Institutionalization

    1 year after hospital admission for pneumonia

  • Survival

    1 year after hospital admission for pneumonia

Study Arms (2)

Multidisciplinar intervention

EXPERIMENTAL

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

Other: Multidimensional intervention

Conventional follow up

NO INTERVENTION

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

Interventions

Multidimensional interventionOTHER

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.

Also known as: Comprehensive geriatric assesment
Multidisciplinar intervention

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (1)

  • Torres OH, Gil E, Comas MT, Saez ME, Clotet S, Ramirez HD, Mateo M, Ruiz D. [Impact of a multidimensional intervention in elderly patients with community-acquired pneumonia: IMIEPCAP clinical trial]. Rev Esp Geriatr Gerontol. 2016 Jan-Feb;51(1):37-43. doi: 10.1016/j.regg.2015.09.004. Epub 2015 Oct 30. Spanish.

    PMID: 26526565BACKGROUND

Related Links

MeSH Terms

Conditions

Community-Acquired PneumoniaHealthcare-Associated PneumoniaPneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesCross InfectionLung DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olga H Torres, Phd

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

    PRINCIPAL INVESTIGATOR

  • Domingo Ruiz, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

January 28, 2011

Study Start

November 1, 2010

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

ES(1)