Dysphagia and Pneumonia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01974089
Recruitment Status : Unknown
Verified October 2013 by Dorte Melgaard Kristiansen, Vendsyssel Hospital.
Recruitment status was:  Recruiting
First Posted : November 1, 2013
Last Update Posted : November 1, 2013
Information provided by (Responsible Party):
Dorte Melgaard Kristiansen, Vendsyssel Hospital

Brief Summary:
To determine the prevalence of dysphagia among Danish patients hospitalized with pneumonia and to test whether it is possible to reduce the swallowing disorders by changing the consistence of food and drink. Patients hospitalized in the period from the 1st of September 2013 to the 31st of March 2014 will be tested by an occupational therapist for dysphagia within the first 24 hours of their hospitalization. The endpoints will be number of hospitalization days, rehospitalisation and mortality. If the test is positive, the patient will get a diet of a manageable consistency to avoid dysphagia.

Condition or disease Intervention/treatment Phase
Dysphagia Pneumonia Other: Modified diet Not Applicable

Detailed Description:

Hypothesis: Screening for and treating of dysphagia among patients with CAP can reduce rehospitalisation and mortality.

The aims of the study are 1) to show the prevalence of dysphagia in patients with CAP and 2) to prevent rehospitalisation of patients with aspiration pneumonia and 3) to reduce mortality.

The management of patients with dysphagia requires the coordinated expertise of a number of health-care professionals including doctors, nurses, dieticians and occupational therapists, as well as the primary caregivers. Occupational therapists will be responsible for the screening and the management of the dysphagia program. The nurses at the Lung Unit are all introduced to the importance of the diet and the postural changes to prevent dysphagia, and they will take over when the program has been implemented. In this project there will be focus on dietary adjustments and postural changes. There is weak evidence for the effect of preventing dysphagia by using thickened liquids and changing the posture, but even then there is consensus for this practice among experienced occupational therapists (22). When discharged the patients will receive a brochure about the importance of maintaining the diet, it will be noted what diet they have to follow, and primary caregivers will also be informed. Three weeks after discharge the patient will be visited by a primary occupational therapist and a dietrist. The occupational therapist will retest the patient and the dietrist will make sure the patient keep weight. Both will have a dialogue with the patient about the importance of maintaining the diet.

There has not yet been made a calculation about how many patients to include, but according to experiences from study 1 we expect to include 200 patients.

Outcome: number of hospitalization days, rehospitalisation within 30 days and within 180 days and mortality during hospitalization, within 30 days and within 180 days.

The study is a cross-sectional study. The collected data will be demographic data, level of pneuonia, comorbidity, BMI, tooth-status, number of hospitalization days, rehospitalisation and mortality. The study is registered by the Danish Data Protection Authority (2008-58-0028)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dysphagia in Patients With Community Acquired Pneumonia
Study Start Date : October 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Modified diet Other: Modified diet

Primary Outcome Measures :
  1. Rehospitalization [ Time Frame: 180 after discharge ]

Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: 180 days after discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • have to be hospitalized due to pneumonia
  • Admitted on a lung ward

Exclusion Criteria:

  • if patient suffers from dementia
  • if patient is palliative, e.g. cancer patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01974089

Vendsyssel Hospital Recruiting
Hjoerring, Denmark, 9800
Contact: Dorte M Kristiasen, Master of Rehabilitation    + 45 97 64 10 48   
Principal Investigator: Dorte M Kristiasen, Master of Rehabilitation         
Sponsors and Collaborators
Vendsyssel Hospital

Responsible Party: Dorte Melgaard Kristiansen, Developmental therapist, Vendsyssel Hospital Identifier: NCT01974089     History of Changes
Other Study ID Numbers: DM-2
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by Dorte Melgaard Kristiansen, Vendsyssel Hospital:
Modified diet
Community acquired pneumonia

Additional relevant MeSH terms:
Deglutition Disorders
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases