NCT04959877

Brief 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

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
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

June 8, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

November 29, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

June 20, 2021

Last Update Submit

November 26, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Dysphagia Severity Rating Scale

    Scale assessment by MBS ( 1 Non Oral - 7 Full oral intake)

    up to 1 year

  • Functional oral intake scale

    Scale assessment (1nothing by mouth - 7 full oral intake)

    up to 1 year

  • Penetration Aspiration Scale

    Scale Assessment by MBS (1 No airway penetration - 8 Airway aspiration, no cough)

    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)

    up to 1 year

Secondary Outcomes (1)

  • SwalQOL

    Up to 1 year

Study Arms (1)

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

Interventions

data collect / Telemedicine

1

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with oropharyngeal dysphagia who require speech therapy

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la santa creu i sant Pau

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Helena Bascuñana Ambros, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2021

First Posted

July 13, 2021

Study Start

June 8, 2021

Primary Completion

January 1, 2022

Study Completion

April 1, 2022

Last Updated

November 29, 2021

Record last verified: 2021-11

Locations