Preventing Aggression in Veterans With Dementia

Completed · Phase 3

Conditions studied: Dementia, Aggression, Pain

In brief

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.

Key facts

Study ID

NCT01325714

Run by

VA Office of Research and Development

People needed

203

Starts

2011-05-01

Expected to finish

2015-09-01

Last updated by the study team

2016-06-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients will be eligible to participate in the study if they meet the following criteria:
• have a documented diagnosis of dementia
• receive primary care from the VA
• reside outside a long-term care facility
• live within 45 minutes of the MEDVAMC
• have mild-to-moderate dementia
• have no history of aggression in the past year
• have no evidence of aggression on the CMAI at baseline (i.e., do not score 2 or higher on both frequency and disruptiveness for any of 13 behaviors listed).
• have a caregiver who is directly involved with the patient:
• at least 8 hours per week
• sees the patient at least twice a week
• and speaks English
• report clinically significant pain (either directly or through the caregiver as a proxy)

You may not qualify if…

• Patients will be excluded if they have had history of aggression in the past year
• The investigators will administer the aggression subscale of the Cohen-Mansfield Agitation Inventory (CMAI)
• Aggression will be considered present if any of the following items are endorsed as having occurred over the prior year:
• 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
• Participants that scored 2 or higher for both frequency and disruptiveness on any of the 13 behaviors listed on the CMAI at baseline were considered aggressive and were excluded from the study.

Where it is running

• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

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