Deglutition DisordersNCT02328196
Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment
An observational study of Deglutition Disorders, run by Metropolitan University College at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deglutition Disorders
- What is being tested?
- The Danish McGill Ingestive Skills Assessment (MISA-DK)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 328 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clients +18 years referred to occupational therapy for swallowing evaluation because of known or suspected dysphagia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment for Measuring Dysphagic Clients' Performance During Meals
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.
Read the 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.
- Conditions
- Deglutition Disorders
- Being tested
- The Danish McGill Ingestive Skills Assessment (MISA-DK)
- Keywords
- Outcome and Process Assessment (Health Care), Rasch analysis, Meal time performance
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Danish McGill Ingestive Skills Assessment (MISA-DK)Behavioural
The MISA measures the performance of dysphagic patients during the patient's usual mealtime routine.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deglutition DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metropolitan University College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tina Hansen, Metropolitan University College
- Investigators
- Tina Hansen, PhD, Principal investigator, Metropolitan University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328196
- Sponsor's protocol ID
- MetropolitanUC
- Status last verified
- Mar 2016
- First submitted
- 17 Dec 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individuel participant data are not available for other than the principal Investigator. This is approved by the Danish Data Protection Authority.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Revised Version of the Danish McGill Ingestive Skills Assessment for Measuring Dysphagic Clients' Performance During Meals
- ClinicalTrials.gov ID
- NCT02328196
- Acronym / sponsor ID
- MetropolitanUC
- Conditions
- Deglutition Disorders
- Keywords
- Outcome and Process Assessment (Health Care), Rasch analysis, Meal time performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Metropolitan University CollegeUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clients +18 years referred to occupational therapy for swallowing evaluation because of known or suspected dysphagia
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Danish McGill Ingestive Skills Assessment (MISA-DK)The MISA measures the performance of dysphagic patients during the patient's usual mealtime routine. | Behavioural | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Individual participant dataSharing planned: No. Individuel participant data are not available for other than the principal Investigator. This is approved by the Danish Data Protection Authority.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tina Hansen, PhD principal investigator
Metropolitan University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition Disorders, run by Metropolitan University College at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Danish version of The McGill Ingestive Skills Assessment (MISA-DK) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.