Deglutition DisordersNCT05862142
A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients
An observational study of Deglutition Disorders and Otorhinolaryngologic Diseases, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
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. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Deglutition Disorders, Otorhinolaryngologic Diseases, Oropharyngeal Dysphagia
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 6 Jun 2023to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Older people between 65 and 99 years.
- Swallowing assessed with Videofluoroscopy
- Non-hospitalized patients (swallowing assessed on an outpatient basis)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients: Building Bridges Between Detection and Decision-making
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.
Read the 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.
- Being tested
- No intervention
- Keywords
- Older people, Predictive models
- Medical subject headings
- Deglutition Disorders, Otorhinolaryngologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 years
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.
Measured: Up to 8 years
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.
Measured: Up to 8 years
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.
Measured: Up to 8 years
Secondary outcomes (1)
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.
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start6 Jun 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05862142
- Sponsor's protocol ID
- IIBSP-DOF-2022-121
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients: Building Bridges Between Detection and Decision-making
- ClinicalTrials.gov ID
- NCT05862142
- Acronym / sponsor ID
- IIBSP-DOF-2022-121
- Keywords
- Older people, Predictive models
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 6 Jun 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Older people between 65 and 99 years.
- Swallowing assessed with Videofluoroscopy
- Non-hospitalized patients (swallowing assessed on an outpatient basis)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Dysphagia Outcome and Severity Scale (DOSS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
1 secondary outcome
Predictive value of pharyngeal width at rest for aspiration (JOSCYL width). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS)
Time frame: Up to 8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders and Otorhinolaryngologic Diseases, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Víctor Najas Sales, SLP (+34696554925 ext. 37011, vnajas@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia Outcome and Severity Scale (DOSS). Instrumental assessment tool used: Videofluoroscopic Swallowing study (VFSS) (time frame: Up to 8 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.