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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
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society (CCS)
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date August 4, 2011
First Posted Date August 18, 2011
Last Update Posted Date August 8, 2018
Study Start Date October 2010
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2011)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Testing of a New Scale Measuring Medical Outcomes of Dysphagia (MOD) in Adult Patients With Swallowing Disorders
Official Title Not Provided
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients and outpatients of the University Health Network who have a diagnosis of dysphagia.
Condition Dysphagia
Intervention Not Provided
Study Groups/Cohorts Dysphagia
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 7, 2018)
280
Original Estimated Enrollment
 (submitted: August 17, 2011)
500
Actual Study Completion Date July 2018
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01419886
Other Study ID Numbers CIHR-93685, CCSRI-020190
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • Canadian Cancer Society (CCS)
Investigators
Principal Investigator: Rosemary Martino, PhD University of Toronto / University Health Network
PRS Account University Health Network, Toronto
Verification Date August 2018