Nctid:
NCT00000362
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000011014", "term"=>"Pneumonia"}, {"id"=>"D000011015", "term"=>"Pneumonia, Aspiration"}], "ancestors"=>[{"id"=>"D000012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M13213", "name"=>"Parkinson Disease", "relevance"=>"LOW"}, {"id"=>"M6904", "name"=>"Dementia", "relevance"=>"LOW"}, {"id"=>"M13904", "name"=>"Pneumonia", "asFound"=>"Pneumonia", "relevance"=>"HIGH"}, {"id"=>"M6882", "name"=>"Deglutition Disorders", "relevance"=>"LOW"}, {"id"=>"M13905", "name"=>"Pneumonia, Aspiration", "asFound"=>"Pneumonia, Aspiration", "relevance"=>"HIGH"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>600}}, "statusModule"=>{"overallStatus"=>"TERMINATED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2006-04", "completionDateStruct"=>{"date"=>"2006-01"}, "lastUpdateSubmitDate"=>"2006-04-21", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2006-04-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Deglutition Disorders", "Dementia", "Parkinson Disease", "Pneumonia, Aspiration"], "conditions"=>["Pneumonia, Aspiration"]}, "referencesModule"=>{"references"=>[{"pmid"=>"18378947", "type"=>"DERIVED", "citation"=>"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. Erratum In: Ann Intern Med. 2008 May 6;148(9):715."}]}, "descriptionModule"=>{"briefSummary"=>"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."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"95 years", "minimumAge"=>"50 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows.\n\nExclusion Criteria:\n\n* Have smoked more than a pack of cigarettes per day in the last year.\n* Drink more than 3 alcoholic beverages per day on a regular basis.\n* Have had any head and neck cancer treatment.\n* Have any head and neck anatomic deformities.\n* Have a history of 20 years or longer of insulin-dependent diabetes.\n* Have other exclusionary neurologic diagnoses.\n* Have had pneumonia within 6 weeks of screening.\n* Currently have a nasogastric tube.\n* Currently have a tracheotomy.\n* Are a resident in non-participating nursing home or assisted living environment.\n* Live alone.\n* Have no regular care provider present at meals.\n* Have no Speech-Language Pathologist to provide a 3-month follow-up."}, "identificationModule"=>{"nctId"=>"NCT00000362", "briefTitle"=>"Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)"}, "orgStudyIdInfo"=>{"id"=>"NIDCD-1159"}, "secondaryIdInfos"=>[{"id"=>"Protocol 201"}, {"id"=>"U01DC003206", "link"=>"https://reporter.nih.gov/quickSearch/U01DC003206", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Chin-down position", "type"=>"BEHAVIORAL"}, {"name"=>"Thickened liquid administration", "type"=>"BEHAVIORAL"}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Madison", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"University of Wisconsin at Madison & multiple other U.S. locations", "geoPoint"=>{"lat"=>43.07305, "lon"=>-89.40123}}], "overallOfficials"=>[{"name"=>"Dr. Joanne Robbins", "role"=>"STUDY_CHAIR"}, {"name"=>"Dr. Jeri Logemann", "role"=>"PRINCIPAL_INVESTIGATOR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)", "class"=>"NIH"}}}}