NCT04402307

Brief Summary

Effect of training of patients with dysphagia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

8 active sites

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

March 25, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2019

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

May 26, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

1.8 years

First QC Date

April 1, 2019

Last Update Submit

October 12, 2021

Conditions

Dysphagia

Keywords

TrainingEffectElderly

Outcome Measures

Primary Outcomes (1)

  • Readmission

    Number of readmissions within 6 months

    6 months

Secondary Outcomes (4)

  • Change in Quality of life

    3 months

  • Cost effectiveness

    6 months

  • Mortality

    6 months

  • Swallowing function

    3 months

Study Arms (2)

Usual care

NO INTERVENTION

Usual care to patients with dysphagia

Training

EXPERIMENTAL

Chin Tuck Against Resistance to patients with dysphagia

Other: Chin Tuck Against Resistance

Interventions

Chin Tuck Against ResistanceOTHER

Training in 6 weeks 3 times a day.

Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Jammerbugt municipality

Brovst, 9460, Denmark

Location

Brøndby municipality

Brøndby, 2605, Denmark

Location

Frederikshavn municipality

Frederikshavn, 9900, Denmark

Location

Hjørring municipality

Hjørring, 9800, Denmark

Location

Kolding municipality

Kolding, 6000, Denmark

Location

Odense municipality

Odense, 5100, Denmark

Location

Slagelse municipality

Slagelse, 4200, Denmark

Location

Tønder municipality

Tønder, 6270, Denmark

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Dorte M Kristiansen, PhD

    Regionshospital Nordjylland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Seniorresearcher, research coordinator, ph.d.

Study Record Dates

First Submitted

April 1, 2019

First Posted

May 26, 2020

Study Start

March 25, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 13, 2021

Record last verified: 2021-10

Locations

DK(8)