NCT03643991已完成不适用
Decreasing Agitation in Patients With Dementia Through the Use of Weighted Blankets: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
研究概览
简要总结
The purpose of this research study is to determine whether the use of weighted blankets help reduce behavioral and psychological symptoms, including agitation in people with dementia.
详细描述
The Intervention Group
- Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
- Nursing staff will complete baseline assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
- A weighted blanket, based on admission body weight, will be provided to the patient under nursing supervision.
- For 3 consecutive days after each use of weighted blanket, nursing staff will complete morning assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
- At the end of the intervention, nursing staff will complete post-intervention assessments to measure behavioral disturbances using the CMAI and CGI and other distressing symptoms using the ESAS-r.
Control Group:
- Patient or Legally Authorized Representative (LAR) will be asked to sign a consent form and will have the study explained.
- The study team will recruit a group of patients with similar characteristics as described in the inclusion criteria; however, the patient will not receive the weighted blanket, but undergo the same assessments as described in 1-5 (above) and in the Schedule of Assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted on the inpatient geriatric psychiatry unit, complex interventions unit, internal medicine service and/or admitted hospice GIP
- •Documented diagnosis of dementia or suspected major neurocognitive disorder.
- •Presence of agitation/aggression symptoms as defined by a minimum aggression score on the Cohen-Mansfield Agitation Inventory Short Version (CMAI): Patients must score 3, 4, or 5 on at least one question related to aggression (items 1-4).
- •Have a LAR able to sign the consent on behalf of the patient.
排除标准
- •Severe pain likely to be exacerbated by use of weighted blanket
- •Inability to remove blanket;
- •Skin burns or open wounds;
- •Admitted on 72 hour hold.
结局指标
主要结局
Cohen-Mansfield Agitation Inventory Short Version (CMAI) Change
时间窗: At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket
Assess the agitation/aggression outcome using numeric scales ranging from 1-5. The sum of the scores is defined as the agitation/aggression outcome and ranges from 14-70, with the lower score being the better outcome.
次要结局
- The revised Edmonton Symptom Assessment System Revised (ESAS-r) Change(At baseline and within 72 hours of the last use of the weighted blanket.)
- Clinical Global Impressions (CGI)(At baseline, days 1-3, and then within 72 hours of last use of the weighted blanket)
研究者
Maria I. Lapid, M.D.
Principle Investigator
Mayo Clinic
研究点 (2)
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