An observational study in Dysphagia, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by University Health Network, Toronto · Observational
Swallowing disorders (dysphagia) are common in adult patients. There is emerging evidence that dysphagia itself can cause adverse medical outcomes. There is a three-fold increased risk for pneumonia in these patients versus similar patients without dysphagia. Patients with dysphagia also suffer poor nutrition and dehydration. Patients can become so malnourished that it slows their recovery. Dysphagia can cause choking when food or liquid enters the lungs. Over time, this will cause pneumonia and even death. More acutely, patients fear that their choking will cause them to suffocate and die. Over time, patients are embarrassed to be seen choking and thus feel forced to dine alone. These patients report feelings of isolation and depression. To date, there are no practical methods to assess these adverse outcomes of swallowing difficulties in patients. This research will be the first to address this gap. Specifically, as part of previous research (PhD dissertation by RM, the PI) a new measure of medical outcomes of dysphagia was developed, titled the Medical Outcomes of Dysphagia (MOD) scale. The MOD consists of 3 subscales that each measure lung, nutrition-hydration or psychological consequences in patients with swallowing difficulties. Unlike more expensive and complex tests, the MOD has been designed for both in- and outpatients. This research will validate each MOD subscale to ensure retention of only items that are reliable and valid for use with patients who have dysphagia due to any disease etiology. The final MOD subscales will be the first to allow clinicians to track medical complications in their patients and to ensure that treatment is effective. Globally, the MOD subscales will direct limited health care resources to the most effective treatments for swallowing disorders.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 280 is above the median of 97 across 207 observational studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inpatients and outpatients of the University Health Network who have a diagnosis of dysphagia.
Exclusion Criteria:
Reliability of the MOD subscales
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
Time frame: 24 hours
Validity of the MOD subscales
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.
Time frame: 24 hours
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto