DysphagiaEDU-DISNCT04959877
Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia
An observational study of Dysphagia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
When reviewing the literature, the need to investigate the health education of patients with dysphagia and their family members / caregivers has been detected. Numerous articles mention or it can be inferred from them that an education or training has been carried out for the patient and caregivers, but the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- health education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jun 2021to Apr 2022
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with oropharyngeal dysphagia who require speech therapy
Who may be able to join
- People between 18 and 99 years old diagnosed by videofluoroscopy of oropharyngeal dysphagia and who are candidates for speech therapy treatment for this reason.
- Knowledge of the language sufficient to understand the audiovisual material on health education available at: logopediasantpau.wordpress.com
- Have the necessary technological tools to carry out the telematic processing (electronic device with Internet access and WhatsApp) and know how to use them or have a family member / direct caregiver with basic technological skills.
- Signature of the informed consent
Who cannot join
- Moderate or severe cognitive impairment already known from the medical history or evaluated with the MoCA test in the absence of a family member or caregiver.
- Having undergone speech therapy treatment for oropharyngeal dysphagia in the last year.
- Not signing the informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la santa creu i sant Pau
Barcelona, 08041
Helena Bascuñana, Dr, 932919000, hbascunana@santpau.cat
About this study
When reviewing the literature, the need to investigate the health education of patients with dysphagia and their family members / caregivers has been detected. Numerous articles mention or it can be inferred from them that an education or training has been carried out for the patient and caregivers, but the investigators have not found any that specifically focuses on this aspect of the intervention. Only in some Clinical Practice Guidelines is the need for health education included
- Conditions
- Dysphagia
- Being tested
- health education
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationBehavioural
data collect / Telemedicine
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed with oropharyngeal dysphagia who require speech therapy treatment for this reason and who have voluntarily opted for the blended treatment modality. Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia Severity Rating Scale
Scale assessment by MBS ( 1 Non Oral - 7 Full oral intake)
Measured: up to 1 year
Functional oral intake scale
Scale assessment (1nothing by mouth - 7 full oral intake)
Measured: up to 1 year
Penetration Aspiration Scale
Scale Assessment by MBS (1 No airway penetration - 8 Airway aspiration, no cough)
Measured: up to 1 year
Bolus Residual Scale
Scale Assessment by MBS (1 No residues - 6 Residue in Valleculae and posterior Pharyngeal wall and piriform sinus)
Measured: up to 1 year
Secondary outcomes (1)
SwalQOL
Quality of life related to oropharyngeal dysphagia (11 Domains)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start8 Jun 2021
- Primary completionJan 2022 (estimated)
- Study completionApr 2022 (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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04959877
- Sponsor's protocol ID
- IIBSP-EDU-2021-50
- Acronym
- EDU-DIS
- Status last verified
- Nov 2021
- First submitted
- 20 Jun 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia
- ClinicalTrials.gov ID
- NCT04959877
- Acronym / sponsor ID
- EDU-DIS / IIBSP-EDU-2021-50
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 13 Jul 2021 (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.
When reviewing the literature, the need to investigate the health education of patients with dysphagia and their family members / caregivers has been detected. Numerous articles mention or it can be inferred from them that an education or training has been carried out for the patient and caregivers, but the investigators have not found any that specifically focuses on this aspect of the intervention. Only in some Clinical Practice Guidelines is the need for health education included
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: health educationPatients diagnosed with oropharyngeal dysphagia who require speech therapy treatment for this reason and who have voluntarily opted for the blended treatment modality. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with oropharyngeal dysphagia who require speech therapy
Key inclusion criteria (4 listed)
- People between 18 and 99 years old diagnosed by videofluoroscopy of oropharyngeal dysphagia and who are candidates for speech therapy treatment for this reason.
- Knowledge of the language sufficient to understand the audiovisual material on health education available at: logopediasantpau.wordpress.com
- Have the necessary technological tools to carry out the telematic processing (electronic device with Internet access and WhatsApp) and know how to use them or have a family member / direct caregiver with basic technological skills.
- Signature of the informed consent
Key exclusion criteria (3 listed)
- Moderate or severe cognitive impairment already known from the medical history or evaluated with the MoCA test in the absence of a family member or caregiver.
- Having undergone speech therapy treatment for oropharyngeal dysphagia in the last year.
- Not signing the informed consent.
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 |
|---|---|---|
| health educationdata collect / Telemedicine | Behavioural | 1 |
Primary outcome
Dysphagia Severity Rating Scale
Time frame: up to 1 year
Scale assessment by MBS ( 1 Non Oral - 7 Full oral intake)
Functional oral intake scale
Time frame: up to 1 year
Scale assessment (1nothing by mouth - 7 full oral intake)
Penetration Aspiration Scale
Time frame: up to 1 year
Scale Assessment by MBS (1 No airway penetration - 8 Airway aspiration, no cough)
Bolus Residual Scale
Time frame: up to 1 year
Scale Assessment by MBS (1 No residues - 6 Residue in Valleculae and posterior Pharyngeal wall and piriform sinus)
1 secondary outcome
SwalQOL
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Dysphagia
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 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 Nov 2021. 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 Spain. 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 Helena Bascuñana Ambros, MD, PhD (932919000, hbascunana@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia Severity Rating Scale (time frame: up to 1 year). 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 Nov 2021.