Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Caregiver primary subjective stress- Phase 2, 3mo
研究概览
简要总结
The TBI-AD/ADRD Caregiver Support Intervention (TACSI) incorporates psychosocial and psychoeducational approaches with the objective of: a) identifying stressors associated with caregiving for family members who have the dual diagnosis of traumatic brain injury and dementia; and b) supporting caregivers in developing more effective coping and communication strategies as well as enhanced caregiving self-efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •the care recipient has a physician diagnosis of TBI and AD/ADRD (i.e., those with a diagnosis of both TBI and progressive cognitive decline)
- •the caregiver self-identifies as someone who provides the most help/is most responsible for the person with TBI-AD/ADRD because of their cognitive impairments (or shares the role equally with another caregiver)
- •the caregiver indicates a willingness to participate in the TACSI evaluation
- •the caregiver is English speaking
- •the caregiver is 21 years of age or older
- •the caregiver is not currently participating in any other type of service that provides one-to-one psychosocial consultation or caregiver coaching (peer mentorship/support group participation/general counseling not specific to caregiving is not a deterrent to enrollment) at the discretion of the UMN research team
- •the caregiver resides in the US.
排除标准
- •caregivers who have a new or worsening mental health condition and are not receiving ongoing treatment. When applicable, if caregivers have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics or anti-psychotics, for the prior three months they will be excluded.
研究组 & 干预措施
TACSI
干预措施: TBI-AD/ADRD Caregiver Support Intervention (TACSI) (Other)
Usual care control group
The usual care control group would have continued receipt of standard services at either the Mayo Clinic or the MVAHCS. In addition, staff will offer participants the opportunity to request supportive/educational resources as needed after randomization.
结局指标
主要结局
Caregiver primary subjective stress- Phase 2, 3mo
时间窗: change in score from baseline to 3 months
Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 6mo
时间窗: change in score from baseline to 6 months
Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 1
时间窗: change in score from baseline to 3 months
Change in score from baseline to Module 6
次要结局
未报告次要终点