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

Not yet recruiting

• Conditions: Oropharyngeal Dysphagia; Deglutition Disorders; Otorhinolaryngologic Diseases

• Registration Number: NCT05862142
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31
• Study Start: 2023-06-06
• Primary Completion: 2024-08-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dysphagia Outcome and Severity Scale (DOSS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	Up to 8 years	It is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment and make recommendations for diet level, independence level, and type of nutrition Range: 1 Nothing by mouth (NPO) - 7 Full oral intake, normal.
Penetration Aspiration Scale (PAS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	Up to 8 years	It is a is a rank ordered scale that classifies the depth of penetrated or aspirated material and the patient's response to airway invasion. Range: 1 No airway penetration - 8 Airway aspiration, no cough.
Bolus Residue Scale (BRS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	Up to 8 years	It is a simple, easy-to-carry-out, and accessible analysis method to rate and locate pharyngeal retention. Range: 1 No residue - 6 Residue in valleculae and posterior pharyngeal wall and piriform sinus.
Functional Oral Intake Scale (FOIS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	Up to 8 years	It is a reliable and valid tool to assess functional oral intake of food and liquids in patients with oropharyngeal dysphagia (OD). Range: 1 Nothing by mouth (NPO) - 7 Full oral intake without restrictions.

Secondary Outcome Measures

Name	Time	Method
Predictive value of pharyngeal width at rest for aspiration (JOSCYL width). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	Up to 8 years	The JOSCYL Width Scale is calculated by averaging two pharyngeal widths: 1) lower margin of the mandible to C2 and 2) epiglottis to C3.