NCT00259467已完成1 期
Tailored Activity to Improve Affect in Dementia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Caregiver upset
研究概览
简要总结
Specific Aims
- Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months
- Evaluate acceptance of and engagement in activities in persons with dementia
- Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months.
- Evaluate caregiver skills acquisition, acceptance of and compliance to intervention techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Care Recipient
- •English Speaking
- •NINCDS-ADRDA diagnosis[physician generated of dementia or mini-mental state examination score of less than or equal to 23;3] Able to feel self; and participates in at least 2 other activities of daily living[ADLs-Bathing, Dressing, Grooming, Toileting, Transferring from bed to chair] As reported by caregiver.
- •Caregiver
- •English Speaking
- •Family member 21 years of age or older [male or female]
- •Lives with Care Recipient
- •Has telephone in the home
- •Plans to live in area for 8 months
- •Indicated willingness to learn new approaches by which to engage care recipient in meaningful activities
- •Provides 4 or more hours a day directly caring or providing for care recipient
排除标准
- •Care Recipient
- •Has Schizophrenia or Bi-Polar Disorder
- •Their Dementia is secondary to probable head trauma
- •Their MMSE score is equal to zero and they are bed bound, defined as confinement to bed or chair for at least 22 hours a day for at least 4 of 7 days
- •They are not responsive to their environment
- •Caregiver
- •Are currently involved in another clinical trial of psycho-social or educational interventions for caregivers
- •Are planning to place their family member in a nursing home within the next 8 months. Also, the care recipient/caregiver dyad will be excluded if either caregiver or care recipient: 1) has a terminal illness with life expectancy less than 8 months 2)is in active treatment for cancer or 3) has had greater than 3 acute medical hospitalizations within the past year.
结局指标
主要结局
Caregiver upset
Care recipient depressive mood
Behavioral occurrence
次要结局
- Activity engagement and vigilance
研究者
研究点 (2)
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