Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia (EDU-DIS)

November 26, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with oropharyngeal dysphagia who require speech therapy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients diagnosed with oropharyngeal dysphagia who require speech therapy treatment for this reason and who have voluntarily opted for the blended treatment modality.
Behavioral: health education
data collect / Telemedicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysphagia Severity Rating Scale
Time Frame: up to 1 year
Scale assessment by MBS ( 1 Non Oral - 7 Full oral intake)
up to 1 year
Functional oral intake scale
Time Frame: up to 1 year
Scale assessment (1nothing by mouth - 7 full oral intake)
up to 1 year
Penetration Aspiration Scale
Time Frame: up to 1 year
Scale Assessment by MBS (1 No airway penetration - 8 Airway aspiration, no cough)
up to 1 year
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)
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SwalQOL
Time Frame: Up to 1 year
Quality of life related to oropharyngeal dysphagia (11 Domains)
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

June 20, 2021

First Submitted That Met QC Criteria

July 12, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 26, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-EDU-2021-50

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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