Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
3 other identifiers
interventional
600
1 country
1
Brief Summary
The purpose of this study is to determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Liquid aspiration is the most common type of aspiration in older populations, especially those suffering from debilitation, dementia, and depression. Pneumonia may develop as a consequence of aspiration and is the fifth leading cause of death in the US among persons age 65 years and over. Current treatment involves either use of chin-down position with swallowing or use of thickened liquids in the diet, without any clear evidence supporting the use of one treatment over the other. This is a Phase III inpatient and/or outpatient study in which all participants will be randomly assigned to either the chin-down position or the thickened liquid treatment group based on swallowing function during a modified barium swallow. This study is scheduled to recruit patients for a three-year period; participation by each individual patient spans no more than three months after entry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
November 3, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedApril 24, 2006
April 1, 2006
November 2, 1999
April 21, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows.
You may not qualify if:
- Have smoked more than a pack of cigarettes per day in the last year.
- Drink more than 3 alcoholic beverages per day on a regular basis.
- Have had any head and neck cancer treatment.
- Have any head and neck anatomic deformities.
- Have a history of 20 years or longer of insulin-dependent diabetes.
- Have had pneumonia within 6 weeks of screening.
- Currently have a nasogastric tube.
- Currently have a tracheotomy.
- Are a resident in non-participating nursing home or assisted living environment.
- Live alone.
- Have no regular care provider present at meals.
- Have no Speech-Language Pathologist to provide a 3-month follow-up.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin at Madison & multiple other U.S. locations
Madison, Wisconsin, United States
Related Publications (1)
Robbins J, Gensler G, Hind J, Logemann JA, Lindblad AS, Brandt D, Baum H, Lilienfeld D, Kosek S, Lundy D, Dikeman K, Kazandjian M, Gramigna GD, McGarvey-Toler S, Miller Gardner PJ. Comparison of 2 interventions for liquid aspiration on pneumonia incidence: a randomized trial. Ann Intern Med. 2008 Apr 1;148(7):509-18. doi: 10.7326/0003-4819-148-7-200804010-00007.
PMID: 18378947DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dr. Joanne Robbins
- PRINCIPAL INVESTIGATOR
Dr. Jeri Logemann
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
November 3, 1999
Study Completion
January 1, 2006
Last Updated
April 24, 2006
Record last verified: 2006-04