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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01385007 |
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Date of registration:
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24/06/2011 |
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Primary sponsor: |
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Public title:
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Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans
PAVED-T |
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Scientific title:
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Preventing Aggression In Veterans With Dementia (PAVED) - Telephone Sub-Study With Rural Veterans |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01385007 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. diagnosis of dementia
2. pain symptoms documented by the HBPC staff
3. residence in a VA designated rural area of Lufkin or Conroe
4. presence of a caregiver
5. Enrolled in Home Based Primary Care at Michael E DeBakey VA Medical Center
Exclusion Criteria:
1. display of aggression (spitting, cursing/verbal aggression, hitting, kicking, grabbing, pushing, throwing, biting, scratching, hurting self/others, tearing things/destroying property, making inappropriate verbal sexual advances, or making inappropriate physical sexual advances) in the past year
2. score of 6 or greater on the Functional Assessment Staging (FAST) scale
3. inability to complete by phone a cognitive screening assessment (Telephone Interview for Cognitive Status) or the Philadelphia Geriatric Pain Intensity Scale.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dementia
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Pain
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Intervention(s)
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Behavioral: Preventing Aggression in Veterans with Dementia (PAVeD)
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Primary Outcome(s)
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Incidence of Aggression
[Time Frame: 3 months and 6 months post-intervention]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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