Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia, Aspiration

Keywords

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Deglutition Disorders Dementia Parkinson Disease Pneumonia, Aspiration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Chin-down position

Intervention Type BEHAVIORAL

Thickened liquid administration

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows.

Exclusion Criteria

* 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 other exclusionary neurologic diagnoses.
* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Dr. Joanne Robbins

Role: STUDY_CHAIR

Dr. Jeri Logemann

Role: PRINCIPAL_INVESTIGATOR

Locations

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University of Wisconsin at Madison & multiple other U.S. locations

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED

PMID: 18378947 (View on PubMed)

Other Identifiers

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Protocol 201

Identifier Type: -

Identifier Source: secondary_id

U01DC003206

Identifier Type: NIH