Effect of Training of Patients With Dysphagia

October 12, 2021 updated by: Dorte Melgaard Kristiansen, Vendsyssel Hospital
Effect of training of patients with dysphagia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomised controlled study in the effect of training in patients with dysphagia.

The patients are randomised for training or for usual care.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Brovst, Denmark, 9460
        • Jammerbugt municipality
      • Brøndby, Denmark, 2605
        • Brøndby municipality
      • Frederikshavn, Denmark, 9900
        • Frederikshavn municipality
      • Hjørring, Denmark, 9800
        • Hjørring municipality
      • Kolding, Denmark, 6000
        • Kolding municipality
      • Odense, Denmark, 5100
        • Odense municipality
      • Slagelse, Denmark, 4200
        • Slagelse Municipality
      • Tønder, Denmark, 6270
        • Tønder municipality

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with dysphaigia
  • Patients living in the participating locations

Exclusion Criteria:

  • Patients who are linguistically or cognitively unable to participate
  • Patients who are unable to collaborate about the training
  • Palliative patients
  • Patients with a probe

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Usual care to patients with dysphagia
Experimental: Training
Chin Tuck Against Resistance to patients with dysphagia
Other: Chin Tuck Against Resistance
Training in 6 weeks 3 times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission
Time Frame: 6 months
Number of readmissions within 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of life
Time Frame: 3 months
Level of quality of life - measured with Dysphagia Handicap Index questionnaire
3 months
Cost effectiveness
Time Frame: 6 months
Economic evaluation of training compared to usual care, measured with EQ-5D
6 months
Mortality
Time Frame: 6 months
Mortality in patients with dysphagia within 6 months
6 months
Swallowing function
Time Frame: 3 months
Aspiration (yes/no) - measured with Volume Viscosity Swallow Test
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vendsyssel Hospital

Investigators

  • Principal Investigator: Dorte M Kristiansen, PhD, North Denmark Regional Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 1, 2019

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHN_DMK_05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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