Dysphagia in Elderly Medical Patients (DEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006330
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : June 16, 2011
Information provided by:
Herlev Hospital

Brief 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.

Condition or disease
Deglutition Disorders Impaired Cognition Physical Activity Complete Immobility Due to Frailty Respiratory Tract Infections

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.

Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dysphagia in Elderly Medical Patients: Occupational Therapy Evaluation and Prevalence
Study Start Date : November 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Elderly medical inpatients

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006330

Occupational Therapy department, Herlev Hospital
Herlev, The Capital Region, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Principal Investigator: Tina Hansen, MSc PHD stud Herlev Hospital, Region H

Responsible Party: Tina Hansen, MSc.OT, Herlev Hospital Identifier: NCT01006330     History of Changes
Other Study ID Numbers: CVR29190623
HC-2009-061 ( Registry Identifier: The local ethical committee in the Capital region )
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: October 2009

Additional relevant MeSH terms:
Respiratory Tract Infections
Deglutition Disorders
Cognitive Dysfunction
Respiratory Tract Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders