PneumoniaCHO-CAPNCT00812084
Costs, Health Status and Outcomes of CAP (Community-Acquired Pneumonia)
An observational study of Pneumonia, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The purpose of this study is to collect additional data on hospitalized Community-Acquired Pneumonia (CAP) on health states, health outcomes and on (health) resources and estimate the differences in the quality of life and resources of elderly persons with and without CAP. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pneumonia
- How many people
- 48,634 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2008to Oct 2014
- Phase
- Observational
- 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
Study population: The study population consists of community-dwelling persons 65 years and older and taking part in the CAPITA trial, in total 85,000 persons
Who may be able to join
- Only participants of the CAPITA trial. Therefore the inclusion criteria as applied in CAPITA are the baseline for the current study. Additionally all participants had to be consent and had to fill in a baseline EQ-5D questionnaire
- Additionally for CAP patients: Consent to be filling to participate as a CAP and the presence of CAP has to be confirmed by the independent adjudication committee of the main CAPITA trial
- Additionally for controls: Consent to be filling to participate as control
Who cannot join
- The non-availability of a baseline EQ-5D score is an exclusion criterion for the prospectively followed cohorts (both CAP patients and controls)
- In all stages of the study, patients have the right to withdraw their consent and stop their participation in this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Questionnaires are filled in at participants home addresses
The Netherlands
About this study
Official title: Collecting Health Outcomes and Economic Data on Hospitalized Community-Acquired Pneumonia - a Prospective Cohort Study
The purpose of this study is to collect additional data on hospitalized Community-Acquired Pneumonia (CAP) on health states, health outcomes and on (health) resources and estimate the differences in the quality of life and resources of elderly persons with and without CAP.
Read the detailed description
Within the study data on quality of life and various health and non-health resources and their costs is collected with the help of questionnaires administered at different points in time in different cohorts. Data collection is additional upon data collected in the main CAPITA trial, such as incidence data, mortality estimates, use of some health care resources, vaccine effectiveness and general background (socio-demographic) data.
In a first sub-study of CHO-CAP, the CAPITA participants are asked, via written information distributed shortly after vaccination, to fill in once-only a short questionnaire describing their health status (5 item EQ-5D instrument) and a few additional socio-demographic background data. This is done in order to determine an EQ-5D baseline score (index value for health status) - a prerequisite to match CAP patients and controls later, and as such an inclusion criterion for the two (nested) cohorts that will be followed prospectively.
About 2,000 cases of CAP are expected to occur in the CAPITA cohort in the next two to three years. Assuming a response rate of ~30% for the baseline questionnaire, we will have some 600 CAP cases out of the 2,000 expected patients for whom a baseline EQ-5D score is available. These CAP patients will be asked to participate in a prospective cohort study. Within CHO-CAP, these CAP cases will be followed for up to one year after their CAP episode. For each CAP case included in the CAP cohort, two controls from the baseline population are matched and included in a cohort of controls (non-CAP elderly with similar baseline health status). Controls will also be followed for up to one year. The matches between CAP cases and controls will be made based on age, sex and EQ-5D baseline score. This implies that controls will only be recruited from the group that responded to the baseline measurement of health status shortly after vaccination. For both cohorts, the CAP patients and the matched controls, additional data on health care and non-health care resource use, on health status, using EQ-5D and SF-36 questionnaires, and on selected health outcomes is collected at four contact (at 0, 1, 6 and 12 months) moments within a period of 1 year. This will be done using questionnaires, distributed during a home visit and by post.
- Conditions
- Pneumonia
- Keywords
- Quality of life, health resources, costs, community-acquired pneumonia
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAP cohort | Includes cases that were hospitalized because of a community-acquired pneumonia during the study period, and for which we had a baseline EQ-5D score from the start of the study period. These CAP cases are prospectively followed for up to one year using questionnaires for health status and (health) resources. | |
| Controls cohort | For each CAP cases, two controls are matched based on age, sex and baseline EQ-5D score measured at the start of the study. These controls are prospectively followed for up to one year using questionnaires for health status and (health) resources. |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Differences in) the quality of life/health status of elderly persons with and without CAP; inclusive of a 12-months follow-up period after occurrence of a CAP
Measured: 12-months follow-up after CAP
(Differences in) the resources use (health care and non-health care) by CAP patients and non-diseased controls; inclusive of follow-up of 12 months after discharge
Measured: 12-months follow-up after CAP
Secondary outcomes (1)
To describe the baseline health status and quality of life in a community-dwelling population of 65 years and older
Measured: at the begin of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 48,634 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, G.A. de Wit, UMC Utrecht
- Investigators
- G.Ardine de Wit, PhD, Principal investigator, Julius Center for Health Sciences and Primary Care; UMC UtrechtMarc J.M. Bonten, Prof., MD PhD, Principal investigator, Julius Center for Health Sciences and Primary Care; UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00812084
- Sponsor's protocol ID
- 6115A1-3015
- Acronym
- CHO-CAP
- Status last verified
- Jun 2015
- First submitted
- 18 Dec 2008
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mangen MJ, Huijts SM, Bonten MJ, de Wit GA. The impact of community-acquired pneumonia on the health-related quality-of-life in elderly. BMC Infect Dis. 2017 Mar 14;17(1):208. doi: 10.1186/s12879-017-2302-3.
PubMed 28292280Mangen MJ, Bolkenbaas M, Huijts SM, van Werkhoven CH, Bonten MJ, de Wit GA. Quality of life in community-dwelling Dutch elderly measured by EQ-5D-3L. Health Qual Life Outcomes. 2017 Jan 6;15(1):3. doi: 10.1186/s12955-016-0577-5.
PubMed 28069062Mangen MJ, Bonten MJ, de Wit GA. Rationale and design of the costs, health status and outcomes in community-acquired pneumonia (CHO-CAP) study in elderly persons hospitalized with CAP. BMC Infect Dis. 2013 Dec 19;13:597. doi: 10.1186/1471-2334-13-597.
PubMed 24354588
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collecting Health Outcomes and Economic Data on Hospitalized Community-Acquired Pneumonia - a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00812084
- Acronym / sponsor ID
- CHO-CAP / 6115A1-3015
- Conditions
- Pneumonia
- Keywords
- Quality of life, health resources, costs, community-acquired pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48,634 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Nov 2008
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Dec 2008 (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 purpose of this study is to collect additional data on hospitalized Community-Acquired Pneumonia (CAP) on health states, health outcomes and on (health) resources and estimate the differences in the quality of life and resources of elderly persons with and without CAP.
Detailed description
Within the study data on quality of life and various health and non-health resources and their costs is collected with the help of questionnaires administered at different points in time in different cohorts. Data collection is additional upon data collected in the main CAPITA trial, such as incidence data, mortality estimates, use of some health care resources, vaccine effectiveness and general background (socio-demographic) data.
In a first sub-study of CHO-CAP, the CAPITA participants are asked, via written information distributed shortly after vaccination, to fill in once-only a short questionnaire describing their health status (5 item EQ-5D instrument) and a few additional socio-demographic background data. This is done in order to determine an EQ-5D baseline score (index value for health status) - a prerequisite to match CAP patients and controls later, and as such an inclusion criterion for the two (nested) cohorts that will be followed prospectively.
About 2,000 cases of CAP are expected to occur in the CAPITA cohort in the next two to three years. Assuming a response rate of ~30% for the baseline questionnaire, we will have some 600 CAP cases out of the 2,000 expected patients for whom a baseline EQ-5D score is available. These CAP patients will be asked to participate in a prospective cohort study. Within CHO-CAP, these CAP cases will be followed for up to one year after their CAP episode. For each CAP case included in the CAP cohort, two controls from the baseline population are matched and included in a cohort of controls (non-CAP elderly with similar baseline health status). Controls will also be followed for up to one year. The matches between CAP cases and controls will be made based on age, sex and EQ-5D baseline score. This implies that controls will only be recruited from the group that responded to the baseline measurement of health status shortly after vaccination. For both cohorts, the CAP patients and the matched controls, additional data on health care and non-health care resource use, on health status, using EQ-5D and SF-36 questionnaires, and on selected health outcomes is collected at four contact (at 0, 1, 6 and 12 months) moments within a period of 1 year. This will be done using questionnaires, distributed during a home visit and by post.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAP cohort | – | –Includes cases that were hospitalized because of a community-acquired pneumonia during the study period, and for which we had a baseline EQ-5D score from the start of the study period. These CAP cases are prospectively followed for up to one year using questionnaires for health status and (health) resources. |
| Controls cohort | – | –For each CAP cases, two controls are matched based on age, sex and baseline EQ-5D score measured at the start of the study. These controls are prospectively followed for up to one year using questionnaires for health status and (health) resources. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of community-dwelling persons 65 years and older and taking part in the CAPITA trial, in total 85,000 persons
Key inclusion criteria (3 listed)
- Only participants of the CAPITA trial. Therefore the inclusion criteria as applied in CAPITA are the baseline for the current study. Additionally all participants had to be consent and had to fill in a baseline EQ-5D questionnaire
- Additionally for CAP patients: Consent to be filling to participate as a CAP and the presence of CAP has to be confirmed by the independent adjudication committee of the main CAPITA trial
- Additionally for controls: Consent to be filling to participate as control
Key exclusion criteria (2 listed)
- The non-availability of a baseline EQ-5D score is an exclusion criterion for the prospectively followed cohorts (both CAP patients and controls)
- In all stages of the study, patients have the right to withdraw their consent and stop their participation in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
(Differences in) the quality of life/health status of elderly persons with and without CAP; inclusive of a 12-months follow-up period after occurrence of a CAP
Time frame: 12-months follow-up after CAP
(Differences in) the resources use (health care and non-health care) by CAP patients and non-diseased controls; inclusive of follow-up of 12 months after discharge
Time frame: 12-months follow-up after CAP
1 secondary outcome
To describe the baseline health status and quality of life in a community-dwelling population of 65 years and older
Time frame: at the begin of the study
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 12 Jun 2015.
- Derived from this study: PubMed 28292280Mangen MJ, Huijts SM, Bonten MJ, de Wit GA. The impact of community-acquired pneumonia on the health-related quality-of-life in elderly. BMC Infect Dis. 2017 Mar 14;17(1):208. doi: 10.1186/s12879-017-2302-3.
- Derived from this study: PubMed 28069062Mangen MJ, Bolkenbaas M, Huijts SM, van Werkhoven CH, Bonten MJ, de Wit GA. Quality of life in community-dwelling Dutch elderly measured by EQ-5D-3L. Health Qual Life Outcomes. 2017 Jan 6;15(1):3. doi: 10.1186/s12955-016-0577-5.
- Derived from this study: PubMed 24354588Mangen MJ, Bonten MJ, de Wit GA. Rationale and design of the costs, health status and outcomes in community-acquired pneumonia (CHO-CAP) study in elderly persons hospitalized with CAP. BMC Infect Dis. 2013 Dec 19;13:597. doi: 10.1186/1471-2334-13-597.
- The CHO-CAP study uses the CAPITA research infrastructure to collect additional data on hospitalized CAP not covered in the main trial. CAPITA is registered with clinicalTrials.gov as: NCT00744263.Link 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.
G.Ardine de Wit, PhD principal investigator
Julius Center for Health Sciences and Primary Care; UMC Utrecht
Marc J.M. Bonten, Prof., MD PhD principal investigator
Julius Center for Health Sciences and Primary Care; UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by UMC Utrecht at 1 site in Netherlands.
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 2 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 12 Jun 2015. 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 Netherlands. 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?
(Differences in) the quality of life/health status of elderly persons with and without CAP; inclusive of a 12-months follow-up period after occurrence of a CAP (time frame: 12-months follow-up after CAP). The study lists 2 primary outcomes in all. 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 NCT00812084, which also lists 3 linked publications.
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 12 Jun 2015.