NCT03820791

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 29, 2019

Status Verified

October 1, 2018

Enrollment Period

Same day

First QC Date

November 15, 2018

Last Update Submit

January 25, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Poster

EXPERIMENTAL

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

No poster

NO INTERVENTION

No poster is placed in patients' room.

Interventions

Patients and their caregivers will be exposed to the poster for one month

Poster

Eligibility Criteria

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

You may qualify if:

  • 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,
  • years of age or older,
  • receiving regular visits from their family members or caregivers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CINTESIS - Faculty of Medicine of the University of Porto

Porto, 4200-450, Portugal

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Irene P Carvalho, PhD

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene P Carvalho, PhD

CONTACT

António Soares, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2018

First Posted

January 29, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

January 29, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations