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

Deglutition Disorders Clinical Trial

Official title:

A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients: Building Bridges Between Detection and Decision-making

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05862142
• Other study ID #: IIBSP-DOF-2022-121
• Status: Not yet recruiting
• Start date: June 6, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Víctor Najas Sales, SLP
• Phone: +34696554925
• Email: vnajas[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: November 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Oropharyngeal Dysphagia
• Otorhinolaryngologic Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia Outcome and Severity Scale (DOSS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	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.	Up to 8 years
Primary	Penetration Aspiration Scale (PAS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	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.	Up to 8 years
Primary	Bolus Residue Scale (BRS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	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.	Up to 8 years
Primary	Functional Oral Intake Scale (FOIS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	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.	Up to 8 years
Secondary	Predictive value of pharyngeal width at rest for aspiration (JOSCYL width). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)	The JOSCYL Width Scale is calculated by averaging two pharyngeal widths: 1) lower margin of the mandible to C2 and 2) epiglottis to C3.	Up to 8 years