NCT01974089

Brief Summary

This study investigates relationship between community acquired pneumonia and oropharyngeal dysphagia in patients admitted to a department of respiratory medicine in Northern Denmark. The endpoints will be re-hospitalisation and mortality.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

October 1, 2018

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

Same day

First QC Date

October 25, 2013

Results QC Date

February 2, 2018

Last Update Submit

April 10, 2019

Conditions

Keywords

DysphagiaCommunity acquired pneumoniaMortalityRehospitalization

Outcome Measures

Primary Outcomes (3)

  • Intra Hospital Mortality

    Intra hospital mortality is death while the patient is hospitalized

    With in 10 days from admission

  • 30 Day Mortality

    Death within 30 days of discharge

    30 days after discharge

  • Re-hospitalization

    The rate of re-hospitalization within 30 days of discharge

    30 days after discharge

Study Arms (2)

Pneumonia and dysphagia

Patients with community aquired pneumonia and oropharyngea dysphagia

Other: Dysphagia

Pneumonia

Patients with community aquired pneumonia

Interventions

Oropharyngeal dysphagia assessed by Volume-Viscosity Svallowing Test

Pneumonia and dysphagia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospitalized patients recruited from the Department of Respiratory Medicine at North Denmeark Regional Hospital.

You may qualify if:

  • Temperature \> 38 degrees Celcius
  • New infiltrate on chest x-ray
  • Increased C-reactive protein (CRP)
  • Either cough, dyspnea, pleuritic chest pain, expectoration, or tachypnea

You may not qualify if:

  • patients referred from the intensive care unit
  • reduced cognitive awareness if not able to able to cooperate with the assessment of oropharyngeal dysphagia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vendsyssel Hospital

Hjørring, 9800, Denmark

Location

MeSH Terms

Conditions

Deglutition DisordersPneumoniaCommunity-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesCommunity-Acquired Infections

Limitations and Caveats

Small sample size. The definition of community acquired pneumonia is vague and unclear and there is a risk that some patients may be hospitalized with aspiration pneumonia, a subtype of community acquired pneumonia.

Results Point of Contact

Title
Dorte Melgaard
Organization
Centre for Clinical Research, North Denmark Regional Hospital, Hjoerring, Denmark

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Developmental therapist, phd

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 1, 2013

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Study Completion

March 1, 2014

Last Updated

April 24, 2019

Results First Posted

October 1, 2018

Record last verified: 2019-04

Locations