Dysphagia in Elderly Medical Patients (DEM)

June 15, 2011 updated by: Herlev Hospital

Dysphagia in Elderly Medical Patients: Occupational Therapy Evaluation and Prevalence

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.

Study Overview

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

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Elderly medical inpatients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Tina Hansen, MSc PHD stud, Herlev Hospital, Region H

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

October 30, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (ESTIMATE)

November 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 15, 2011

Last Verified

October 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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