Clinical trial NCT05862142: A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients
Official title: A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients: Building Bridges Between Detection and Decision-making
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deglutition Disorders
Otorhinolaryngologic Diseases
Oropharyngeal Dysphagia
Keywords: Older people
Predictive models
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Older patients (≥ 65 years) referred to the Physical Medicine and Rehabilitation Service of Hospital de la Santa Creu i Sant Pau for a swallowing study between 2015 and 2023.

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.

Detailed description: Given the high prevalence of Oropharyngeal Dysphagia (OD) in older people and the difficulty to detect it, the investigators 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dysphagia Outcome and Severity Scale (DOSS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)
timeFrame: Up to 8 years
measure: Penetration Aspiration Scale (PAS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)
timeFrame: Up to 8 years
measure: Bolus Residue Scale (BRS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)
timeFrame: Up to 8 years
measure: Functional Oral Intake Scale (FOIS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)
timeFrame: Up to 8 years
Secondary outcomes:
measure: Predictive value of pharyngeal width at rest for aspiration (JOSCYL width). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)
timeFrame: Up to 8 years
Other outcomes:
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