Phase 3
N=203
Preventing Aggression in Veterans With Dementia
Dementia · Aggression · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01325714 ↗Enrolled (actual)
203
Serious AEs
9.4%
Results posted
May 2016
Primary outcome: Primary: Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) — 8; 14; 9; 17 participants — p=0.13
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PAVeD Intervention (Behavioral); Enhanced Usual Care (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale) |
8; 14; 9; 17; 17; 14 | 0.13 |
| SECONDARY Caregiver-Reported Worst Pain |
3.28; 3.03; 2.83; 2.91; 2.77; 2.85 | 0.46 |
| SECONDARY Patient-reported Worst Pain. |
3.01; 2.84; 2.49; 2.41; 2.35; 2.72 | 0.23 |
| SECONDARY Caregiver Reported Overall Pain Over the Last Several Weeks |
2.43; 2.06; 1.99; 1.84; 1.96; 1.96 | 0.23 |
| SECONDARY Patient-reported Overall Pain Over the Last Several Weeks |
2.13; 1.96; 1.71; 1.66; 1.75; 1.92 | 0.62 |
| SECONDARY Depression |
14.33; 13.97; 13.17; 14.26; 12.81; 14.01 | 0.42 |
| SECONDARY Pleasant Events - Short Form - Alzheimer's Disease |
23.09; 24.65; 24.01; 24.81; 24.41; 24.06 | 0.35 |
| SECONDARY Caregiver Burden |
28.94; 28.63; 26.88; 30.37; 27.84; 32.00 | 0.11 |
| SECONDARY Caregiver-perceived Mutuality |
2.93; 2.99; 3.01; 2.82; 3.02; 2.78 | 0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
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)
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01325714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.