Costs, Health Status and Outcomes of CAP (Community-Acquired Pneumonia) (CHO-CAP)
Collecting Health Outcomes and Economic Data on Hospitalized Community-Acquired Pneumonia - a Prospective Cohort Study
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
The Netherlands, Olanda
- Questionnaires are filled in at participants home addresses
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
(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
Lasso di tempo: 12-months follow-up after 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
Lasso di tempo: 12-months follow-up after CAP
|
12-months follow-up after CAP
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
To describe the baseline health status and quality of life in a community-dwelling population of 65 years and older
Lasso di tempo: at the begin of the study
|
at the begin of the study
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: G.Ardine de Wit, PhD, Julius Center for Health Sciences and Primary Care; UMC Utrecht
- Investigatore principale: Marc J.M. Bonten, Prof., MD PhD, Julius Center for Health Sciences and Primary Care; UMC Utrecht
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 6115A1-3015
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .