Implementation Of Phototherapy In Patients With Dementia To Improve BPSD: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Feasibility of 5-day phototherapy protocol
研究概览
简要总结
The purpose of this research is to determine whether the use of phototherapy can help reduce behavioral and psychological symptoms, including agitation in people with dementia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted on the inpatient Domitilla 3D or 4D unit.
- •Documented diagnosis of dementia or suspected major neurocognitive disorder.
- •Presence of BPSD symptoms either clinician documented in EHR or assessed through CMAI-O form
- •Have patient consent or have a LAR able to sign the consent on behalf of the patient.
排除标准
- •Macular degeneration, blindness, or photosensitivity
- •Patients that do not have capacity to consent and do not have a legally authorized representative to consent on their behalf
- •Recent eye surgery
- •Bipolar disorder
- •Pregnancy
研究组 & 干预措施
Standard of Care
Patients in the standard of care group will not receive an intervention.
Phototherapy
Patients in the phototherapy arm will receive bright light therapy for 60 minutes, 3 times per day for 5 days.
干预措施: Phototherapy (Other)
结局指标
主要结局
Feasibility of 5-day phototherapy protocol
时间窗: Day 5
Feasibility will be defined as the percentage of eligible patients who choose to enroll in the study out of total patients approached.
Acceptability of 5-day phototherapy protocol
时间窗: Day 5
Accessibility will be defined as the percentage of study participants to complete at least one session per day of the 5-day protocol
Tolerability of 5-day phototherapy protocol
时间窗: Day 5
Tolerability will be defined as percentage of patients to rate phototherapy as 'very tolerable' based on being asked "Considering all aspects of your experience, how would you rate the overall tolerability of the phototherapy?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable.
次要结局
- Sleep duration(Day 5)
研究者
Stephanie Chambers
Principal Investigator
Mayo Clinic