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Dysphagia and Pneumonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Vendsyssel Hospital
Sponsor:
Information provided by (Responsible Party):
Dorte Melgaard Kristiansen, Vendsyssel Hospital
ClinicalTrials.gov Identifier:
NCT01974089
First received: October 25, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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 Intervention
Dysphagia
Pneumonia
Other: Modified diet

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dysphagia in Patients With Community Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Vendsyssel Hospital:

Primary Outcome Measures:
  • Rehospitalization [ Time Frame: 180 after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality rate [ Time Frame: 180 days after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: October 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Modified diet Other: Modified diet

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01974089

Locations
Denmark
Vendsyssel Hospital Recruiting
Hjoerring, Denmark, 9800
Contact: Dorte M Kristiasen, Master of Rehabilitation    + 45 97 64 10 48    dmk@rn.dk   
Principal Investigator: Dorte M Kristiasen, Master of Rehabilitation         
Sponsors and Collaborators
Vendsyssel Hospital
  More Information

No publications provided

Responsible Party: Dorte Melgaard Kristiansen, Developmental therapist, Vendsyssel Hospital
ClinicalTrials.gov Identifier: NCT01974089     History of Changes
Other Study ID Numbers: DM-2
Study First Received: October 25, 2013
Last Updated: October 31, 2013
Health Authority: Denmark: The North Denmark Region Committee on Health Research Ethics

Keywords provided by Vendsyssel Hospital:
Dysphagia
Modified diet
Community acquired pneumonia
Mortality
Rehospitalization

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

ClinicalTrials.gov processed this record on November 27, 2014