跳至主要内容
临床试验/NCT06421545
NCT06421545已完成不适用

Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Proportion of potential eligible participants

研究概览

简要总结

The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).

详细描述

Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •PWD inclusion criteria are:
  • •Recent (~1 month) chart documented ADRD diagnosis,
  • •ADRD symptom onset after age 65 ,
  • •cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
  • •cognitive awareness of his/her problems (as determined by the treating neurologist), and
  • •ability to understand study and research protocol, as determined by a standardized teach-back method assessment
  • •Additional inclusion criteria for dyads are:
  • •English speaking adults (18 years or older),
  • •dyad lives together,
  • •at least one partner endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression scale subscales)

排除标准

  • •patient is deemed inappropriate by the neurology team,
  • •either partner has a co-occurring terminal illness,
  • •patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.

研究组 & 干预措施

Open Pilot RT-D Dyads

Experimental

Persons living with dementia (PWDs) and their spousal care-partners

干预措施: Resilient Together for Dementia (Behavioral)

结局指标

主要结局

Proportion of potential eligible participants

时间窗: After each dyad completion, throughout study of 1.5-2 months

Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad.

次要结局

  • Proportion of sessions participants attend(After each dyad completion, throughout study of 1.5-2 months)
  • Proportion of participants screened(After each dyad completion, throughout study of 1.5-2 months)
  • Proportion of participants who consent or not consent to participate(After each dyad completion, throughout study of 1.5-2 months)
  • Change in Hospital Anxiety and Depression Scale (HADS)(Baseline and 6 weeks (post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Bannon

Assistant Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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