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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01419886
Other study ID # CIHR-93685, CCSRI-020190
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2010
Est. completion date July 2018

Study information

Verified date August 2018
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 280
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada University Health Network Toronto Ontario

Sponsors (3)

Lead Sponsor Collaborator
University Health Network, Toronto Canadian Cancer Society Research Institute (CCSRI), Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (2)

Martino R, Beaton D, Diamant NE. Perceptions of psychological issues related to dysphagia differ in acute and chronic patients. Dysphagia. 2010 Mar;25(1):26-34. doi: 10.1007/s00455-009-9225-0. Epub 2009 Aug 6. — View Citation

Martino R, Beaton D, Diamant NE. Using different perspectives to generate items for a new scale measuring medical outcomes of dysphagia (MOD). J Clin Epidemiol. 2009 May;62(5):518-26. doi: 10.1016/j.jclinepi.2008.05.007. Epub 2008 Aug 22. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 hours
Primary 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. 24 hours
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