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Effect of Training of Patients With Dysphagia

Primary Purpose

Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Chin Tuck Against Resistance
Sponsored by
Vendsyssel Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphagia focused on measuring Training, Effect, Elderly

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jammerbugt municipality
  • Brøndby municipality
  • Frederikshavn municipality
  • Hjørring municipality
  • Kolding municipality
  • Odense municipality
  • Slagelse municipality
  • Tønder municipality

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Training

Arm Description

Usual care to patients with dysphagia

Chin Tuck Against Resistance to patients with dysphagia

Outcomes

Primary Outcome Measures

Readmission
Number of readmissions within 6 months

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2019
Last Updated
October 12, 2021
Sponsor
Vendsyssel Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04402307
Brief Title
Effect of Training of Patients With Dysphagia
Official Title
Effect of Training of Patients With Dysphagia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vendsyssel Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Effect of training of patients with dysphagia
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
Training, Effect, Elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care to patients with dysphagia
Arm Title
Training
Arm Type
Experimental
Arm Description
Chin Tuck Against Resistance to patients with dysphagia
Intervention Type
Other
Intervention Name(s)
Chin Tuck Against Resistance
Intervention Description
Training in 6 weeks 3 times a day.
Primary Outcome Measure Information:
Title
Readmission
Description
Number of readmissions within 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Quality of life
Description
Level of quality of life - measured with Dysphagia Handicap Index questionnaire
Time Frame
3 months
Title
Cost effectiveness
Description
Economic evaluation of training compared to usual care, measured with EQ-5D
Time Frame
6 months
Title
Mortality
Description
Mortality in patients with dysphagia within 6 months
Time Frame
6 months
Title
Swallowing function
Description
Aspiration (yes/no) - measured with Volume Viscosity Swallow Test
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorte M Kristiansen, PhD
Organizational Affiliation
North Denmark Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jammerbugt municipality
City
Brovst
ZIP/Postal Code
9460
Country
Denmark
Facility Name
Brøndby municipality
City
Brøndby
ZIP/Postal Code
2605
Country
Denmark
Facility Name
Frederikshavn municipality
City
Frederikshavn
ZIP/Postal Code
9900
Country
Denmark
Facility Name
Hjørring municipality
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
Facility Name
Kolding municipality
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Odense municipality
City
Odense
ZIP/Postal Code
5100
Country
Denmark
Facility Name
Slagelse municipality
City
Slagelse
ZIP/Postal Code
4200
Country
Denmark
Facility Name
Tønder municipality
City
Tønder
ZIP/Postal Code
6270
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Effect of Training of Patients With Dysphagia

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