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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG030575 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to test the effectiveness of an enhanced oral hygiene protocol in preventing pneumonia among nursing home residents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enhanced oral care | Experimental |
| |
| Usual care | Active Comparator | The usual oral care provided at the nursing home |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Oral Care | Other | oral brushing plus oral chlorhexidine plus upright feeding positioning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pneumonia | The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe. | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Respiratory Tract Infection Other Than Pneumonia | The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe. | 2.5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent J Quagliarello, MD | Yale University | Principal Investigator |
| Mary Tinetti, MD | Yale University | Study Director |
| Manisha Juthani-Mehta, MD | Yale University | Study Director |
| Peter Peduzzi, PhD | Yale University | Study Director |
| Dorothy Baker, PhD | Yale University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25520333 | Derived | Juthani-Mehta M, Van Ness PH, McGloin J, Argraves S, Chen S, Charpentier P, Miller L, Williams K, Wall D, Baker D, Tinetti M, Peduzzi P, Quagliarello VJ. A cluster-randomized controlled trial of a multicomponent intervention protocol for pneumonia prevention among nursing home elders. Clin Infect Dis. 2015 Mar 15;60(6):849-57. doi: 10.1093/cid/ciu935. Epub 2014 Dec 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | The usual oral care provided at the nursing home Usual oral care : Usual oral care and feeding positioning |
| FG001 | Enhanced Oral Care | Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation |
| |||||||||||||
| Follow Up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Enhanced Oral Care | Study participants receiving 'Enhanced Oral Care' in the study |
| BG001 | Usual Oral Care | Study participants receiving 'Usual Oral Care' in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pneumonia | The number of participants that recorded a 'first pneumonia' during the 2.5 years timeframe. | Posted | Number | participants | 2.5 years |
|
|
Adverse events (both Serious and Other) were collected over the 2.5 year study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enhanced Oral Care | Study participants receiving 'Enhanced Oral Care' in the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
Participant flow and outcome information pertains to data collected through 10/25/2012- the official trial termination date.
Serious and Other Adverse Event information pertains to requested surveillance of subjects through 12/10/2012 per the NIA.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vincent James Quagliarello MD, Professor of Medicine (Infectious Diseases); Clinical Chief, Infectio | Yale University School of Medicine | (203) 785-7571 | vincent.quagliarello@yale.edu |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Usual oral care | Other | Usual oral care and feeding positioning |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
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| Secondary | Lower Respiratory Tract Infection Other Than Pneumonia | The number of participants that recorded a 'lower respiratory tract infection other than pneumonia' during the 2.5 years timeframe. | Posted | Number | participants | 2.5 years |
|
|
|
| 204 |
| 434 |
| 391 |
| 434 |
| EG001 | Usual Oral Care | Study participants receiving 'Usual Oral Care' in the study. | 153 | 400 | 371 | 400 |
| Skin / Soft Tissue Event | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Eye Infection | Eye disorders | Non-systematic Assessment |
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| Respiratory Difficulty | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fall | General disorders | Non-systematic Assessment | Defined as a study participant falling down; the resulting injury leading to hospitalization. |
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| Acute Renal Failure | Renal and urinary disorders | Non-systematic Assessment |
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| Joint Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Gastrointestinal Disturbance | Gastrointestinal disorders | Non-systematic Assessment |
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| Abnormal Blood Glucose | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Acute Chest Pain/Coronary Syndrome | Cardiac disorders | Non-systematic Assessment |
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| Altered Mental Status | Psychiatric disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Blood Pressure Alteration | Vascular disorders | Non-systematic Assessment |
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| Weight Loss | General disorders | Non-systematic Assessment |
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| Leg Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Fever | Infections and infestations | Non-systematic Assessment |
|
| Generalize Malaise | Psychiatric disorders | Non-systematic Assessment |
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| Other | General disorders | Non-systematic Assessment | These Serious Adverse Events were those that led to hospitalization that were otherwise not specified. Given the characteristics of the study population (age, environment), hospitalization is not uncommon. |
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| Unrelated and Unanticipated OTHER | General disorders | Non-systematic Assessment | Unrelated and unanticipated OTHER events deemed to be Serious Adverse Events. |
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| Death | General disorders | Non-systematic Assessment | Death (unrelated to intervention) |
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| Skin / Soft Tissue Event | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Eye Infection | Eye disorders | Systematic Assessment |
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| Respiratory Difficulty | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fall | General disorders | Systematic Assessment |
|
| Gastrointestinal Disturbance | Gastrointestinal disorders | Systematic Assessment |
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| Altered Mental Status | Psychiatric disorders | Systematic Assessment |
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| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Oral Cavity Disturbance | General disorders | Systematic Assessment |
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| Weight Loss | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Leg Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Generalized Malaise | General disorders | Systematic Assessment |
|
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