- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02328196
Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment
Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment for Measuring Dysphagic Clients' Performance During Meals
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will assess the construct validity of a revised version of MISA-DK in the acute and rehabilitative settings by testing it for fit against a multidimensional Rasch model.
Participants in this research will be 500 dysphagic clients from several centres in Denmark, namely 250 acute patients from three Danish Regional university Hospitals in Herning, Hjørring and Odense, and 250 clients in the rehabilitation setting from the Århus Rehabilitation Institute, Hillerød Rehabilitation Institute and the Rehabilitation division of Copenhagen.
Participants who are judged to have a swallowing problem are assessed with the MISA-DK by special educated occupational therapists The MISA-DK assessment are implemented as a part of the usual assessment routine at the occupational therapy departments at the included centres and will be administered immediately after referral to Occupational therapy. This research will be the first to implement and assess a standardised method for assessing mealtime performance for dysphagia in dysphagic patients across the continuum of diagnosis and rehabilitation recovery.
The application of the Multidimensional Rasch models to the MIS-DK data aims to identify the combination of items in the MISA-DK that provide the highest level of specific objectivity and statistical sufficiency when determining ingestive skill ability. Furthermore, Differential item function by diagnosis, age and setting will be determined.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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N
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Copenhagen, N, Denmark, 2200
- Tina Hansen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Have a history of swallowing difficulties associated with aging and/or previous or current diagnosis of, but not limited to head and neck cancer (treatment may include surgery, radiation or chemotherapy, or a combination of more than one), stroke, cervical spine abnormality, brain tumor, cardiovascular surgery, Parkinson's disease or multi-morbidity.
- Fulfils five criteria for direct swallowing evaluation: able to remain alert for at least 15 minutes; able to sit in a chair or bed in at least a 60° upright position, able to swallow saliva, able to cough voluntarily, able to clear the throat twice.
- Have the capacity to provide informed consent.
Exclusion Criteria:
- The clients are excluded in case of: no dysphagia, known severe cognitive impairment, terminally illness (predicted survival less than 6 months), known contraindications to ingest foods or liquids, poorly controlled psychosis, inability to read consent form; inability or unwillingness to give written informed content.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Danish version of The McGill Ingestive Skills Assessment (MISA-DK)
Time Frame: 1 year
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The MISA-DK is administered as observation of dysphagic clients performance during a usual meal with 14 different textures (four liquids and ten solids).
The MISA-DK is composed of 36 ingestive skill items distributed into four subscales: positioning for meals (four items); self-feeding skills, judgment and behavior (seven items); and oral motor skills for liquid (11 items) and solid ingestion (14 items).
All items are scored on a three-point ordinal scale (1=absent ingestive skill; 2=insufficient ingestive skill performance; 3=adequate ingestive skill performance), which are summated into a total score.
The scores of the 36 ingestive skill items serve as a basis for rehabilitation planning and diet recommendations.
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tina Hansen, PhD, Metropolitan University College
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MetropolitanUC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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