Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment

Deglutition Disorders Clinical Trial

Official title:

Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment for Measuring Dysphagic Clients' Performance During Meals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328196
• Other study ID #: MetropolitanUC
• Status: Completed
• Phase: N/A
• First received: December 17, 2014
• Last updated: March 15, 2016
• Start date: August 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Metropolitan University College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

The McGill Ingestive Skills Assessment (MISA) for measuring dysphagic clients' functional performance during meals has been previously translated into Danish (MISA-DK) and this translated version validated. Critical issues about the construct validity of the scale, per se, had been raised. Consequently, major revisions of the MISA-DK have been undertaken, which necessitates a new validation process. Therefore, the purpose of this study is to evaluate the construct validity of a revised version of the MISA-DK when used amongst dysphagic adults in hospitals settings and community services.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

Behavioral:
• The Danish McGill Ingestive Skills Assessment (MISA-DK)
The MISA measures the performance of dysphagic patients during the patient's usual mealtime routine.

Locations

Country	Name	City	State
Denmark	Tina Hansen	Copenhagen	N

Sponsors (1)

Lead Sponsor	Collaborator
Metropolitan University College

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Danish version of The McGill Ingestive Skills Assessment (MISA-DK)	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.	1 year	No