Testing of a New Scale Measuring Medical Outcomes of Dysphagia (MOD) in Adult Patients With Swallowing Disorders

This study is currently recruiting participants.
Verified June 2012 by University Health Network, Toronto
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01419886
First received: August 4, 2011
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition
Dysphagia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Reliability of the MOD subscales [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: October 2010

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inpatients and outpatients of the University Health Network who have a diagnosis of dysphagia.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419886

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Rosemary Martino, PhD    416-946-8644    rosemary.martino@utoronto.ca   
Contact: Trixie Reichardt, MHSc    416-603-5800 ext 3913    trixie.reichardt@uhnresearch.ca   
Principal Investigator: Rosemary Martino, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)
Canadian Cancer Society Research Institute (CCSRI)
Investigators
Principal Investigator: Rosemary Martino, PhD University of Toronto / University Health Network
  More Information

Additional Information:
Publications:
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01419886     History of Changes
Other Study ID Numbers: CIHR-93685, CCSRI-020190
Study First Received: August 4, 2011
Last Updated: June 18, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Health Canada

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 14, 2014