Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Activities of Daily Living
  • Energy Intake
  • Fat Mass
  • Fluid Balance
  • Lean Body Mass
  • Protein Intake
  • Quality of Life
  • Weight
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomized to control or intervention group, stratified on their FEDSS-score. The study will include 34 participants - 17 in each group.Masking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 99 years
Gender
Both males and females

Description

It is know that people with eating- and swallowing difficulties(known as dysphagia), is prone to weightloss due to insufficient energy- and protein intake, and a reduction in ADL. ADL will in this project have its focus on the eating situation. The projects research questions are: Will dietary guida...

It is know that people with eating- and swallowing difficulties(known as dysphagia), is prone to weightloss due to insufficient energy- and protein intake, and a reduction in ADL. ADL will in this project have its focus on the eating situation. The projects research questions are: Will dietary guidance with texture implementation increase energy intake in patients being examined on an outpatient basis for dysphagia, based on the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) recommendation? Can a dietetic guidance with texture implementation increase quality of life and ADL in patients with dysphagia? Recruitment and data collection will take place at Hammel Neurocenter, DK. Each patient will be included for eight weeks, after their first FEES examination. The participants will be randomized to control or intervention, and strata into three groups based on Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) 1, 2-3 and 4. Within the eight weeks, participants have to show up three times to measurements, interviews and questionnaire, in addition to this, the intervention groups will have three follow-up phone meetings.

Tracking Information

NCT #
NCT04655547
Collaborators
University of Copenhagen
Investigators
Principal Investigator: Jesper Fabricius, Ph.d. Hammel Neurorehabilitation Centre and University Research Clinic