DysphagiaDYSPHAGIANCT03820791
Poster on Dysphagia-specific Food Procedures: Usability and Impact
A study testing Placement of a poster in patients' rooms in people with Dysphagia, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Placement of a poster in patients' rooms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2019to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Failing to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Portugal1 site
CINTESIS - Faculty of Medicine of the University of Porto
Porto, 4200-450
About this study
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
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.
Read the 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.
- Conditions
- Dysphagia
- Being tested
- Placement of a poster in patients' rooms
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a poster in patients' roomsDevice
Patients and their caregivers will be exposed to the poster for one month
| Study group | Role | What they receive |
|---|---|---|
| Poster | Experimental | A poster with pictorial information about dysphagia-specific food procedures placed in patients' rooms for one month Receives: Device: Placement of a poster in patients' rooms |
| No poster | No intervention | No poster is placed in patients' room. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study startJan 2019 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene P Carvalho, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820791
- Sponsor's protocol ID
- DYSPHAGIA
- Acronym
- DYSPHAGIA
- Status last verified
- Oct 2018
- First submitted
- 15 Nov 2018
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03820791
- Acronym / sponsor ID
- DYSPHAGIA / DYSPHAGIA
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 29 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poster | Experimental | Device: Placement of a poster in patients' roomsA poster with pictorial information about dysphagia-specific food procedures placed in patients' rooms for one month |
| No poster | No intervention | –No poster is placed in patients' room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Failing to meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of a poster in patients' roomsPatients and their caregivers will be exposed to the poster for one month | Device | Poster |
Primary outcome
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene P Carvalho, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of a poster in patients' rooms in people with Dysphagia, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene P Carvalho, PhD (225513622, irenec@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patients' aspiration risk before and after placement of the poster in their rooms (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.