NCT03961386Unknown不适用
Development of a Prototype FallsTalk Caregiver Resource System
Brookside Research & Development Company1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年3月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change of Residence
研究概览
简要总结
This randomized-control trial involves dyads consisting of a family caregiver (CG) and a person with memory loss or dementia (PwD). The FallsTalk Caregiver Resource System (FT-C) intervention is administered by the CG, whose role is to modify their interactions with the PwD. FT-C will create a 3-way partnership between an Interventionist and the dyad, capitalizing on CG-PwD interactions. The PwD will be observed by the CG and both will be evaluated by the study team. Brief daily FT-C intervention by the CG will stimulate the PwD's awareness and individualized weekly CG- check-ins with the Interventionist will increase the CG's skills. Our hypothesis is that FT-C will increase PwD's awareness of personal fall threats and encourage new falls prevention behaviors, resulting in reduced fall rates.
详细描述
This is a single-site preliminary trial enrolling dyads in Western Washington state only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Caregiver (CG) Inclusion Criteria:
- •residence in western Washington state
- •minimum age= 18
- •family CG
- •primary CG
- •some daily personal contact with Person with Dementia (PwD) for 1 month
- •basic computer skills and telephone access
- •able to commit to 6 month study.
- •Persons with Dementia (PwD) Inclusion Criteria:
- •living at home with residence in western Washington state
- •minimum age= 55
- •at least one fall in last 6 months or regular loss of balance
- •can ambulate at least 6 feet
- •ability to communicate thoughts
- •willingness to participate.
排除标准
- •Professional CG (unless primary CG for family member)
- •distance CG unable to be physically present with PwD daily for 1 month
- •terminal illness with less than 6 months to live
- •CG has significant memory loss.
- •PwD Exclusion Criteria:
- •Residence outside of western Washington state
- •Living in Residential care setting
- •non-communicative
- •terminal illness with less than 6 months to live
- •wheel chair or bed bound.
研究组 & 干预措施
FallsTalk-C
Experimental
FallsTalk CG intervention
干预措施: FallsTalk-C (Behavioral)
FallsTalk-C
Experimental
FallsTalk CG intervention
干预措施: FallsTalk (Behavioral)
FallsTalk
Active Comparator
FallsTalk intervention
干预措施: FallsTalk (Behavioral)
PostCardOnly
No Intervention
Postcard only- Control group
结局指标
主要结局
Change of Residence
时间窗: weekly for up to one year
Report of change of primary residence
Rate of falls
时间窗: weekly for up to one year
number of falls per month
次要结局
- Burden Scale for Family Caregivers(BSFC is administered at Initial interview and Follow-up interview one month later.)
- Activity-Specific Balance Confidence scale(Pre-test at Initial interview; Post-test at Follow-up interview one month later)
- Fall Threat Awareness(Pre-test- 5 clips at Initial interview; Post-test- 5 clips at Follow-up interview one month later)
- Caregiver Falls Prevention Concerns(Survey administered at study entry and Follow-up visit.)
研究者
研究点 (1)
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