Testing of a New Scale Measuring Medical Outcomes of Dysphagia (MOD) in Adult Patients With Swallowing Disorders
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ClinicalTrials.gov Identifier: NCT01419886 |
Recruitment Status :
Completed
First Posted : August 18, 2011
Last Update Posted : August 8, 2018
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Condition or disease |
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Dysphagia |
Study Type : | Observational |
Actual Enrollment : | 280 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | July 2018 |
Actual Study Completion Date : | July 2018 |

Group/Cohort |
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Dysphagia |
- Reliability of the MOD subscales [ Time Frame: 24 hours ]Inter-rater reliability will be assessed using the Intraclass Correlation Coefficient (ICC). The MOD is being standardized for clinical purposes; therefore sufficient reliability will be set high at an ICC>0.90
- Validity of the MOD subscales [ Time Frame: 24 hours ]Rasch analysis will be used to: i) develop three separate interval-level MOD subscales each with items mapped along a linear continuum of impairment severity; ii) identify and eliminate redundant items within each subscale, allowing for shorter MOD subscales with less respondent burden, and iii) ensure item properties within each subscale are invariant so that the MOD subscales will work well with a variety of patients regardless of disease type.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Adult (18+ years)
- Any disease etiology, including but not limited to: previous or current diagnosis of head and neck cancer (treatment may include surgery, radiation or chemotherapy, or a combination of more than one), stroke, cervical spine abnormality, brain tumour, cardiovascular surgery, and Parkinson's disease
- Current diagnosis of dysphagia, as determined by a speech language pathologist
- English-speaking
Exclusion Criteria:
- No dysphagia
- Cognitive impairment
- Limited fluency in English

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419886
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5T 2S8 |
Principal Investigator: | Rosemary Martino, PhD | University of Toronto / University Health Network |
Publications:
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT01419886 |
Other Study ID Numbers: |
CIHR-93685, CCSRI-020190 |
First Posted: | August 18, 2011 Key Record Dates |
Last Update Posted: | August 8, 2018 |
Last Verified: | August 2018 |
Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases |