A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862142
Collaborator
(none)
300
17.9

Study Details

Study Description

Brief Summary

Oropharyngeal dysphagia (OD) is a highly prevalent and growing condition in the older population. It affects approximately one in three community-dwelling elderly, almost half of the geriatric patients, and even more than half of elderly nursing home residents.

The main complications of OD are respiratory infections such as aspiration pneumonia, malnutrition, and dehydration. It supposes substantial costs for the healthcare system, increases the risk for (re)admissions and length of stay, and has an important impact on the quality of life of people who suffer from it.

The aim of this study is to develop a predictive model to identify non-hospitalized older patients at risk for oropharyngeal dysphagia, quantify that risk, and facilitate decision-making according to personal, clinical, and socio-emotional characteristics.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Detailed Description

Given the high prevalence of Oropharyngeal Dysphagia (OD) in older people and the difficulty to detect it, we purpose to develop a predictive model to identify non-hospitalized older patients at risk for OD, quantify that risk, and facilitate decision-making.

Objectives:
Main objective:
  • Develop a predictive model for oropharyngeal dysphagia in non-hospitalized older patients (≥ 65 years).
Secondary objectives:
  • Identify predictive factors for OD among the studied population.

  • Contribute to the characterization of OD in older people through a retrospective analysis of videofluoroscopic studies and clinical evaluations.

  • Define different models of intervention from a multidimensional approach.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients: Building Bridges Between Detection and Decision-making
Anticipated Study Start Date :
May 7, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Dysphagia Outcome and Severity Scale (DOSS) [Up to 8 years]

    Scale assessment by MBS (1 Nothing by mouth (NPO) - 7 Full oral intake, normal)

  2. Penetration Aspiration Scale (PAS) [Up to 8 years]

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

  3. Bolus Residue Scale (BRS) [Up to 8 years]

    Scale Assessment by MBS (1 No residue - 6 Residue in valleculae and posterior pharyngeal wall and piriform sinus)

  4. Functional Oral Intake Scale (FOIS) [Up to 8 years]

    Scale assessment (1 Nothing by mouth (NPO) - 7 Full oral intake without restrictions)

Secondary Outcome Measures

  1. JOSCYL width [Up to 8 years]

    Predictive value of pharyngeal width at rest for aspiration

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Older people between 65 and 99 years.

  • Swallowing assessed with Videofluoroscopy

  • Non-hospitalized patients (swallowing assessed on an outpatient basis)

Exclusion Criteria:
  • There are no exclusion criteria in relation to the gender or ethnicity of the participants. Failure to meet one of the inclusion criteria will result in the participant's exclusion from the study sample.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT05862142
Other Study ID Numbers:
  • IIBSP-DOF-2022-121
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023