Costs, Health Status and Outcomes of CAP (Community-Acquired Pneumonia) (CHO-CAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
G.A. de Wit, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00812084
First received: December 18, 2008
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition
Pneumonia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Collecting Health Outcomes and Economic Data on Hospitalized Community-Acquired Pneumonia - a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • (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 ] [ Designated as safety issue: No ]
  • (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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 47000
Study Start Date: November 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812084

Locations
Netherlands
Questionnaires are filled in at participants home addresses
The Netherlands, Netherlands
Sponsors and Collaborators
UMC Utrecht
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: G.Ardine de Wit, PhD Julius Center for Health Sciences and Primary Care; UMC Utrecht
Principal Investigator: Marc J.M. Bonten, Prof., MD PhD Julius Center for Health Sciences and Primary Care; UMC Utrecht
  More Information

Additional Information:
No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: G.A. de Wit, PhD, MSc, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00812084     History of Changes
Other Study ID Numbers: 6115A1-3015
Study First Received: December 18, 2008
Last Updated: December 18, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Quality of life
health resources
costs
community-acquired pneumonia

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 21, 2014