An Analgesic Trial to Reduce Pain and Behavior Disruptions in Nursing Home Residents With Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Mobilization-Observation-Behaviour-Intensity-Dementia Pain Scale (MOBID-2) will be used for changes between the groups at baseline, weeks 2, 4, 6 and 8
研究概览
简要总结
Behavioral expressions, such as agitation and aggression, affect up to 90% of persons with dementia and are a major source of patient and caregiver distress, nursing home placement, anti-psychotic medication use, restraints, and increased health care costs. The purpose of the research study is to investigate whether reducing pain reduces behavioral expressions of Alzheimer's disease (agitation and aggression).
详细描述
The research study will investigate if routine analgesic use will reduce behavioral expressions of dementia and pain in older adults with Alzheimer's disease or other dementias. Using a randomized, placebo-controlled, double-blind, cross-over design, the investigators will compare effects of a routine acetaminophen intervention (650 mg administered routinely by mouth three times per day for 4 weeks) to those of routine placebo (methylcellulose), also given for 4 weeks. The maximum dose to be administered will be 1,950 mg per 24 hours, which is below the current FDA recommendations (maximum dose of 3,000 mg/day).
Participants will be randomly assigned to either treatment or placebo group. The initial treatment phase will last for 4 weeks. At the end of the first 4 weeks, the treatment will be reversed after a 3 day washout period. During the 2nd intervention period, the study drug will be reversed (those receiving acetaminophen will receive the placebo drug and vice versa). The second treatment phase will last for 4 weeks. At the end of 2nd treatment phase, all study treatments will be discontinued
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented diagnosis of Alzheimer's Disease or other dementia
- •history of a typically painful condition, such as osteoarthritis, back pain, or other chronic musculoskeletal pain
- •able to swallow oral medication
- •history of aggressive or agitated behavior (defined as score of > 39 on the Cohen-Mansfield Agitation Inventory),
- •Mini Mental State Exam (MMSE) score < 23
排除标准
- •currently taking acetaminophen or opioid medication on a routine (regularly-scheduled, round the clock) basis
- •receiving hospice care
- •history of liver or renal disease
- •drinks more than 3 alcoholic beverages per day
- •known allergy or adverse reaction to acetaminophen
- •bed-ridden or comatose
- •currently taking warfarin
研究组 & 干预措施
Acetaminophen, then placebo
Participants in this group will receive acetaminophen for the first four weeks, then placebo for the next four weeks.
干预措施: Acetaminophen (Drug)
Acetaminophen, then placebo
Participants in this group will receive acetaminophen for the first four weeks, then placebo for the next four weeks.
干预措施: Placebo (Other)
Placebo, then acetaminophen
Participants in this group will receive placebo for the first four weeks, then acetaminophen for the next four weeks.
干预措施: Acetaminophen (Drug)
Placebo, then acetaminophen
Participants in this group will receive placebo for the first four weeks, then acetaminophen for the next four weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Mobilization-Observation-Behaviour-Intensity-Dementia Pain Scale (MOBID-2) will be used for changes between the groups at baseline, weeks 2, 4, 6 and 8
时间窗: Change from baseline, weeks 2, 4, 6 and 8
The MOBID-2 is a two-part, observational pain behavior measure. Part 1 assesses pain related to the musculoskeletal system (the most common cause of pain in older adults) during a set of standardized, guided movements during morning care (5 items). Part 2 assesses pain that might originate from internal organs, head, and skin and is monitored over time (5 items). If a pain behavior is detected, pain intensity is rated using a 0-10 numerical rating scale.
Cohen-Mansfield Agitation Inventory (CMAI) will be used for changes between the groups at baseline, weeks 2,4, 6 and 8
时间窗: Change from baseline, weeks 2, 4, 6 and 8
The CMAI is a 29-item instrument designed to measure the frequency with which persons with dementia display agitation and other behavioral disturbances. The measure consists of 4 subscales that measure aggressive behavior (hitting, scratching, cursing), physical non-aggressive behavior (pacing, restlessness, disrobing), verbally agitated behavior (complaining, repetitive questions, negativism) and hiding/hoarding. Item frequency is scored on a 1 to 7 scale, with (1) = never, (2) = \< once per week, (3) once or twice per week, (4) several times per week, (5) once or twice per day, (6) several times per day, or (7) several times per hour. Total scores range from 29-203.
次要结局
未报告次要终点