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

NCT00812084 | Completed

• 1 other identifier: 6115A1-3015
• Study Type: observational
• Target: 48,634
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pneumonia

Keywords

Quality of life; health resources; costs; community-acquired pneumonia

Outcome Measures

Primary Outcomes (2)

• (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

  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

  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

  at the begin of the study

Study Arms (2)

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• In all stages of the study, patients have the right to withdraw their consent and stop their participation in this study.

Sponsors & Collaborators

• UMC Utrecht: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Questionnaires are filled in at participants home addresses

The Netherlands, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 28292280 DERIVED

• Mangen 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.

  PMID: 28069062 DERIVED

• Mangen 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.

  PMID: 24354588 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Community-Acquired Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MSc

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: November 1, 2008
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: June 12, 2015

Record last verified: 2015-06

Locations

NL (1)