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Poster on Dysphagia-specific Food Procedures: Usability and Impact (DYSPHAGIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820791
Recruitment Status : Unknown
Verified October 2018 by Universidade do Porto.
Recruitment status was:  Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Study Description
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Brief Summary:
The aim of this study is to evaluate the use of a poster containing information on dysphagia-specific food procedures at two levels: utility from the point of view of patients' caregivers, and impact on patients' health. Half the patients will have the poster placed in their room, whereas the other half will not.

Condition or disease Intervention/treatment Phase
Dysphagia Device: Placement of a poster in patients' rooms Not Applicable

Detailed Description:
Dysphagia is a swallowing disorder that can be associated with clinically relevant complications, and caregivers can play a fundamental role in this process, namely because they feed the patient. However, studies show a lack of professional-caregiver communication in dysphagia, and caregivers' need for more information. Communicating dysphagia-specific food procedures through a visual poster might bridge professional-caregiver communication gaps, with consequences for the patient's health.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Using a Visual Poster Communicating Dysphagia-specific Food Procedures as a Complementary Means of Information to Caregivers in Inpatient Care: Usability and Impact
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Poster
A poster with pictorial information about dysphagia-specific food procedures placed in patients' rooms for one month
 Device: Placement of a poster in patients' rooms
Patients and their caregivers will be exposed to the poster for one month
No Intervention: No poster
No poster is placed in patients' room.


Outcome Measures
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Primary Outcome Measures :
  1. Change in patients' aspiration risk before and after placement of the poster in their rooms [ Time Frame: 1 month ]
    Change in patients' risk of aspiration in dysphagia (with the Gugging Swallowing Screen - GUSS)

  2. Change in patients' capacity for oral intake before and after placement of the poster in their rooms [ Time Frame: 1 month ]
    Change in patients' oral intake capacity in dysphagia (with the Functional Oral Intake Scale - FOIS)

  3. Change in patients' oral health before and after placement of the poster in their rooms [ Time Frame: 1 month ]
    Change in patients' oral health in dysphagia (with the Oral Health Assessment Tool - OHAT)

  4. Change in patients' nutritional health before and after placement of the poster in their rooms [ Time Frame: 1 month ]
    Change in patients' nutritional status in dysphagia (with the Mini Nutritional Assessment - MNA)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with post-acute dysphagia (lesion occurring at least six weeks prior, approximately),
  • remaining in inpatient care for at least one month after the first moment of data collection,
  • 18 years of age or older,
  • receiving regular visits from their family members or caregivers.

Exclusion Criteria:

  • Failing to meet inclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820791


Contacts
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Contact: Irene P Carvalho, PhD 225513622 irenec@med.up.pt
Contact: António Soares, PhD 225513622 ajasoares@med.up.pt

Locations
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Portugal
CINTESIS - Faculty of Medicine of the University of Porto
Porto, Portugal, 4200-450
Sponsors and Collaborators
Universidade do Porto
Investigators
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Principal Investigator: Irene P Carvalho, PhD Universidade do Porto
More Information
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03820791    
Other Study ID Numbers: DYSPHAGIA
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases