CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 203 enrolled
Drug / intervention
PAVeD Intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01325714
NCT01325714Phase 3Completed
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Preventing Aggression in Veterans With Dementia

VA Office of Research and Development·interventional·Posted Mar 30, 2011·Updated Jun 24, 2016

In Brief

A Phase 3 clinical trial evaluating PAVeD Intervention and Enhanced Usual Care for Dementia and 2 related conditions. Completed, enrolled 203 participants across 1 site.

Detailed Summary

This study tests whether education about memory and pain might help to prevent aggression in persons with dementia who have pain. The overall goal of this intervention is to reduce the risk of aggressive behavior by improving several areas of patient life that are known causes of aggression: pain, depression, lack of pleasurable activities, caregiver stress and difficulty in caregiver-patient communication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia, Aggression, Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 30, 2011
Enrollment StartMay 1, 2011
Primary CompletionFeb 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.3 years ago

Interventions

PAVeD Interventionbehavioral

In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.

Enhanced Usual Carebehavioral

In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing. Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.