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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01285869
Other study ID # IIBSP-INT-2010-13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date December 2018

Study information

Verified date February 2019
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Detailed description published in "Revista Española de Geriatría y Gerontología" (see citation and link)


Recruitment information / eligibility

Status Completed
Enrollment 314
Est. completion date December 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Functional status 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
Secondary Institutionalization Data will be obtained by review of medical records and telephone interview one year after discharge. 1 year after hospital admission for pneumonia
Secondary Survival Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge. 1 year after hospital admission for pneumonia
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