Community-acquired PneumoniaIMIEPAPNCT01285869
Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia
A study testing Multidimensional intervention in people with Community-acquired Pneumonia and Healthcare-associated Pneumonia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Healthcare-associated Pneumonia
- What is being tested?
- Multidimensional intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2010to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia: a Prospective Randomized Controlled Trial.
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.
Read the detailed description
Detailed description published in "Revista Española de Geriatría y Gerontología" (see citation and link)
- Being tested
- Multidimensional intervention
- Keywords
- Pneumonia, Intervention Studies, Aged, Aged, 80 and over, Geriatric Assessment
- Medical subject headings
- Community-Acquired Pneumonia, Healthcare-Associated Pneumonia, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional interventionOther
Also called Comprehensive geriatric assesment
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.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinar intervention | Experimental | Patients that will receive the multidimensional intervention during the ambulatory follow-up. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after hospital admission for pneumonia
Secondary outcomes (3)
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).
Measured: 1 year after hospital admission for pneumonia
Institutionalization
Data will be obtained by review of medical records and telephone interview one year after discharge.
Measured: 1 year after hospital admission for pneumonia
Survival
Data will be obtained by review of medical records and telephone interview to patient or relatives one year after discharge.
Measured: 1 year after hospital admission for pneumonia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionJun 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olga H Torres, Phd, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauDomingo Ruiz, MD, Study chair, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285869
- Sponsor's protocol ID
- IIBSP-INT-2010-13
- Acronym
- IMIEPAP
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2011
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26526565
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multidimensional Intervention in Elderly Patients With Pneumonia: a Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01285869
- Acronym / sponsor ID
- IMIEPAP / IIBSP-INT-2010-13
- Keywords
- Pneumonia, Intervention Studies, Aged, Aged, 80 and over, Geriatric Assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Nov 2010 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed description published in "Revista Española de Geriatría y Gerontología" (see citation and link)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinar intervention | Experimental | Other: Multidimensional interventionPatients that will receive the multidimensional intervention during the ambulatory follow-up. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Derived from other acute care hospitals.
- Patients with HIV infection.
- Neutrophil counter<1000/mm3
- Transplanted patients.
- Barthel index<60 points.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional interventionAlso: Comprehensive geriatric assesmentThe 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 | Multidisciplinar intervention |
Primary outcome
Healthcare resources utilization (readmissions and consultations to hospital and emergency department).
Time frame: 1 year after hospital admission for pneumonia
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.
3 secondary outcomes
Functional status
Time frame: 1 year after hospital admission for pneumonia
Institutionalization
Time frame: 1 year after hospital admission for pneumonia
Survival
Time frame: 1 year after hospital admission for pneumonia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Background: PubMed 26526565Torres 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.
- Link to the article with description of the study is providedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga H Torres, Phd principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Domingo Ruiz, MD study chair
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional intervention in people with Community-acquired Pneumonia and Healthcare-associated Pneumonia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare resources utilization (readmissions and consultations to hospital and emergency department). (time frame: 1 year after hospital admission for pneumonia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285869, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.