Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia

Dysphagia Clinical Trial

— EDU-DIS  

Official title:

Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959877
• Other study ID #: IIBSP-EDU-2021-50
• Status: Recruiting
• Start date: June 8, 2021
• Est. completion date: April 2022

Study information

• Verified date: November 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Helena Bascuñana Ambros, MD, PhD
• Phone: 932919000
• Email: hbascunana[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Behavioral:
• health education
data collect / Telemedicine

Locations

Country	Name	City	State
Spain	Hospital de la santa creu i sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia Severity Rating Scale	Scale assessment by MBS ( 1 Non Oral - 7 Full oral intake)	up to 1 year
Primary	Functional oral intake scale	Scale assessment (1nothing by mouth - 7 full oral intake)	up to 1 year
Primary	Penetration Aspiration Scale	Scale Assessment by MBS (1 No airway penetration - 8 Airway aspiration, no cough)	up to 1 year
Primary	Bolus Residual Scale	Scale Assessment by MBS (1 No residues - 6 Residue in Valleculae and posterior Pharyngeal wall and piriform sinus)	up to 1 year
Secondary	SwalQOL	Quality of life related to oropharyngeal dysphagia (11 Domains)	Up to 1 year