Preventing Aggression in Veterans With Dementia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
研究概览
简要总结
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.
详细描述
Dementia is known primarily for its effects on memory, however, eighty percent of persons with dementia also have behavioral disturbances. This is often not addressed, leading to increased use of nursing homes, higher incidence of injury (both patient and caregiver) and the use of tranquilizing medications. Pain is one of the strongest predictors of aggression. The prevalence of pain in persons with dementia is known to be about 50%. Untreated pain is associated with significant negative outcomes, including increased health care use, inactivity and isolation. The investigators aim to determine whether outcome differences exist between active intervention and control conditions in relation to the occurrence of aggressive behavior, pain and depression, and its impact on pleasant activities, caregiver burden, quality of caregiver-patient relationship, antipsychotic use, health-service use, injuries to patient and caregiver, and nursing home placement. The active intervention, Preventing Aggression in Veterans with Dementia (PAVeD), is a family caregiver-focused, home-based intervention that uses psychoeducational and behavioral approaches to help reduce the risk of aggressive behavior in persons with dementia. The objective of PAVeD is to improve several areas of patient life that are known causes of aggression: pain and distress (including mood problems), lack of pleasurable activities, and difficulty in patient-caregiver communication that may negatively affect relationship quality and caregivers' recognition of pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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:
- •cursing/verbal aggression
- •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.
结局指标
主要结局
Number of Participants With Aggression as Determined by the Cohen-Mansfield Agitation Inventory (Aggression Subscale)
时间窗: Three Months, Six Months, Twelve Months Post Intervention
The CMAI lists 13 behaviors (2 verbal and 11 nonverbal) and for each behavior the participant indicates how frequently the behavior occurs (1-5, higher values = greater frequency) and how disruptive the behavior is (1-5, higher values = greater disruptiveness). For any given behavior, if a participant scored a 2 or higher on BOTH frequency (i.e., it occurred "less than once a week" or more often) and disruptiveness (i.e., it was "a little" disruptive or more), he/she was considered aggressive. Overall aggression takes into account all 13 behaviors, whereas verbal aggression only pertains to two behaviors and non-verbal aggression pertains to 11 behaviors. One is considered verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for either of the two verbal behaviors. One is considered non-verbally aggressive if he/she responds with a 2 or higher on both frequency and disruptiveness for any of the 11 non-verbal behaviors.
次要结局
- Caregiver-Reported Worst Pain(Baseline, 3 months, 6 months, and 12 months)
- Patient-reported Worst Pain.(Baseline, 3, 6, and 12 months)
- Caregiver Reported Overall Pain Over the Last Several Weeks(Baseline, 3, 6, and 12 months.)
- Patient-reported Overall Pain Over the Last Several Weeks(Baseline, 3, 6, and 12 months)
- Depression(Baseline, 3, 6, and 12 months)
- Pleasant Events - Short Form - Alzheimer's Disease(Baseline, 0, 3, 6, 12 months)
- Caregiver Burden(Baseline, 3, 6, 12 months)
- Caregiver-perceived Mutuality(Baseline, 3, 6, 12 months)