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

Primary Purpose

Dysphagia

Status
Unknown status
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Placement of a poster in patients' rooms
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dysphagia

Eligibility Criteria

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

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

Sites / Locations

  • CINTESIS - Faculty of Medicine of the University of Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Poster

No poster

Arm Description

A poster with pictorial information about dysphagia-specific food procedures placed in patients' rooms for one month

No poster is placed in patients' room.

Outcomes

Primary Outcome Measures

Change in patients' aspiration risk before and after placement of the poster in their rooms
Change in patients' risk of aspiration in dysphagia (with the Gugging Swallowing Screen - GUSS)
Change in patients' capacity for oral intake before and after placement of the poster in their rooms
Change in patients' oral intake capacity in dysphagia (with the Functional Oral Intake Scale - FOIS)
Change in patients' oral health before and after placement of the poster in their rooms
Change in patients' oral health in dysphagia (with the Oral Health Assessment Tool - OHAT)
Change in patients' nutritional health before and after placement of the poster in their rooms
Change in patients' nutritional status in dysphagia (with the Mini Nutritional Assessment - MNA)

Secondary Outcome Measures

Full Information

First Posted
November 15, 2018
Last Updated
January 25, 2019
Sponsor
Universidade do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT03820791
Brief Title
Poster on Dysphagia-specific Food Procedures: Usability and Impact
Acronym
DYSPHAGIA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2019 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
February 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Poster
Arm Type
Experimental
Arm Description
A poster with pictorial information about dysphagia-specific food procedures placed in patients' rooms for one month
Arm Title
No poster
Arm Type
No Intervention
Arm Description
No poster is placed in patients' room.
Intervention Type
Device
Intervention Name(s)
Placement of a poster in patients' rooms
Intervention Description
Patients and their caregivers will be exposed to the poster for one month
Primary Outcome Measure Information:
Title
Change in patients' aspiration risk before and after placement of the poster in their rooms
Description
Change in patients' risk of aspiration in dysphagia (with the Gugging Swallowing Screen - GUSS)
Time Frame
1 month
Title
Change in patients' capacity for oral intake before and after placement of the poster in their rooms
Description
Change in patients' oral intake capacity in dysphagia (with the Functional Oral Intake Scale - FOIS)
Time Frame
1 month
Title
Change in patients' oral health before and after placement of the poster in their rooms
Description
Change in patients' oral health in dysphagia (with the Oral Health Assessment Tool - OHAT)
Time Frame
1 month
Title
Change in patients' nutritional health before and after placement of the poster in their rooms
Description
Change in patients' nutritional status in dysphagia (with the Mini Nutritional Assessment - MNA)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene P Carvalho, PhD
Phone
225513622
Email
irenec@med.up.pt
First Name & Middle Initial & Last Name or Official Title & Degree
António Soares, PhD
Phone
225513622
Email
ajasoares@med.up.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene P Carvalho, PhD
Organizational Affiliation
Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
CINTESIS - Faculty of Medicine of the University of Porto
City
Porto
ZIP/Postal Code
4200-450
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Poster on Dysphagia-specific Food Procedures: Usability and Impact

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