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

Using a Visual Poster Communicating Dysphagia-specific Food Procedures as a Complementary Means of Information to Caregivers in Inpatient Care: Usability and Impact

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.

Study Overview

• Status: Unknown
• Conditions: Dysphagia
• Intervention / Treatment: Device: Placement of a poster in patients' rooms

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irene P Carvalho, PhD; Phone Number: 225513622; Email: irenec@med.up.pt
• Study Contact Backup: Name: António Soares, PhD; Phone Number: 225513622; Email: ajasoares@med.up.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-450
    • CINTESIS - Faculty of Medicine of the University of Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 month
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)	1 month
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)	1 month
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)	1 month

Collaborators and Investigators

• Sponsor: Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): February 1, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: Dysphagia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No