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CompletedNCT01006330DEMUpdated Jun 16, 2011

Dysphagia in Elderly Medical Patients

An observational study in Deglutition Disorders, Impaired Cognition and Physical Activity, sponsored by Herlev Hospital. Completed at 1 site in Denmark. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2011-06-16.

Sponsored by Herlev Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
110
Ages
65 Years and older
Sex
All
01

Study summary

Dysphagia in hospitalized elders is associated with less positive outcomes in rehabilitation, increased likelihood of readmission, increased comorbidity and mortality, and increased length of hospital stay. In light of an increase in the elderly population in Denmark, the consequences of dysphagia, and the importance of minimizing the risk of disability and frailty, it is vital to emphasize safe participation of the elderly dysphagic patient in eating, drinking and swallowing. Danish occupational therapists have an important role in the dysphagia management, but no Danish evidence-based occupational therapy assessments for dysphagia of elderly medical patients exist. In order to oblige this lack, the objective of the study is to provide an assessment tool with operational definitions of dysphagia which includes the complexity of performance in eating, drinking and swallowing, is evidence-based, and guides occupational therapists in the treatment planning in a client-centred and purposeful manner.

The study involves a quantitative approach, and is initiated by a translation and cultural adaptation of the Canadian "The McGill Ingestive Skills Assessment" (MISA). Hereafter, the psychometric qualities are tested. On basis of the data collected for the psychometrics, the prevalence and characteristics of dysphagia in the study population are investigated. Provided that the psychometric testing of the MISA reveals satisfactory levels, the effect of using the MISA in the treatment planning is investigated.

It is hypothesized that:

The Danish translation of the MISA will demonstrates satisfactory content validity, reliabilities, convergent validity, known-groups validity, predictive validity, criterion validity, high levels of sensitivity/specificity and are responsive to change.

Dysphagia is prevalent in elderly medical patients at the time of admission to acute medical care and there can be found a correlation between dysphagia severity and the presence of comorbidity, disability, frailty, the length of hospital stay, the place of discharge and the number of readmissions for elderly medical patients.

Read the detailed description

The study is divided into four study parts.

Study I aims to translate and cultural adapt the MISA into Danish occupational therapy terminology, to secure equivalency between the original and the translated version, and to test its interrater- and intrarater reliability as well as internal consistency.

Study II aims to investigate the convergent validity, known-groups validity, predictive validity and the responsiveness of the MISA.

Study III aims to test the criterion-related validity and the diagnostic accuracy of the MISA using the Flexible Endoscopic Evaluation of Swallowing (FEES) and the Assessment of Motor and Process Skills (AMPS) as gold standards; and to compare the diagnostic accuracy for aspiration of the MISA compared to the Water Swallow Test, when using the FEES as the gold standard.

Study IV aims to investigate the prevalence and characteristics of dysphagia in elderly medical patients, and to identify its potential associations between comorbidity, disability, frailty, length of hospital stay, place of discharge and number of readmissions.

02

Conditions studied

  • Deglutition Disorders
  • Impaired Cognition
  • Physical Activity
  • Complete Immobility Due to Frailty
  • Respiratory Tract Infections
03

In context

Respiratory Tract Infections

1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.

This study's enrollment of 110 is below the median of 300 across 295 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

Herlev Hospital is the lead sponsor of 195 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

102 internal medical patients admitted to Herlev Hospital are included consecutively.

Inclusion criteria

  • > 65 years
  • needs > 2 days of hospitalization
  • are able to give personal information regarding self, place and time
  • are alert > 30 minutes
  • are able to maintain an upright seating position and head control
  • are able to swallow saliva spontaneously and on command
  • are able to voluntary cough or clear the throat twice
  • working knowledge of the Danish language
  • consent to participate and able to give written informed consent.

Exclusion criteria

Exclusion criteria:

  • needs oral/pharyngeal suctioning
  • use of tube feeding for more than half of the caloric requirements
  • tracheostomy
  • terminally ill
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
110 participants (actual)

Groups and cohorts

  • Elderly medical inpatients
06

Study locations

1 site
  • Occupational Therapy department, Herlev Hospital
    Herlev, The Capital Region 2730, Denmark
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01006330
Lead sponsor
Herlev Hospital
First posted
Nov 1, 2009
Start date
Nov 2009
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jun 16, 2011

Study contacts

Tina Hansen, MSc PHD stud
principal investigator · Herlev Hospital, Region H

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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