Skip to main content
OpenTrials
Completed

NCT Number: NCT02328196

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tina Hansen

Copenhagen, N, 2200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Danish McGill Ingestive Skills Assessment (MISA-DK)

Behavioral

The MISA measures the performance of dysphagic patients during the patient's usual mealtime routine.

Primary outcomes

  1. Danish version of The McGill Ingestive Skills Assessment (MISA-DK)

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Metropolitan University College

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2014
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.