Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of participants screened
研究概览
简要总结
This study will evaluate the feasibility and preliminary efficacy of the novel Resilient Together for Dementia (RT-D) intervention for couples following dementia diagnoses. The primary target is emotional distress, and the program aims to prevent chronic distress in at-risk couples.
详细描述
Both persons living with dementia 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 has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.
A pilot feasibility randomized control trial (RCT; Aim 3; NIA Stage 1B; N=50 dyads) will be conducted of the refined RT-D versus a minimally enhanced educational control (MEUC, educational pamphlet). Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs. MEUC (NIA Stage II). In this subsequent R01, the researcher will examine RT-D's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. The researcher will revise the approach if feasibility benchmarks are not met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Recent (~3 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 their 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 or <5 on the Geriatric Depression Scale)
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
Resilient Together for Dementia
The research team will compare two programs to reduce emotional distress among couples after dementia diagnosis.
干预措施: Resilient Together for Dementia (Behavioral)
Resilient Together for Dementia
The research team will compare two programs to reduce emotional distress among couples after dementia diagnosis.
干预措施: MEUC (Behavioral)
结局指标
主要结局
Proportion of participants screened
时间窗: After each dyad completion, throughout study of 6-8 weeks
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. The research team will measure with the proportion of participants screened.
Proportion of participants who consent or not consent to participate
时间窗: After each dyad completion, throughout study of 6-8 weeks
Feasibility of consent - by keeping a record of all individuals who complete screening that consent, refuse to consent, and the reasons for refusal will be monitored and will review progress in weekly team meetings. The research team will measure with the proportion of participants who consent or not consent to participate
Proportion of sessions participants attend
时间窗: After each dyad completion, throughout study of 6-8 weeks
The number of sessions that enrolled dyads attend as well as missed sessions, treatment dropouts, and reasons for nonattendance will be monitored and will review progress in weekly meetings. The research team will measure with the proportion of sessions participants attend.
Credibility and Expectancy Questionnaire (CEQ)
时间窗: After each dyad completion, throughout study of 6-8 weeks
A scale measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Full scale from 0-10, with higher score indicating higher treatment expectancy
Client Satisfaction Questionnaire
时间窗: After each dyad completion, throughout study of 6-8 weeks
A 3-item questionnaire assessing participants' satisfaction with participation in the study. Full scale from 0-12, with higher score indicating greater satisfaction.
次要结局
- Hospital Anxiety and Depression Scale(Baseline to posttest (6-8 weeks))
- Geriatric Depression Scale(Baseline to posttest (6-8 weeks))
- Perceived Stress Scale(Baseline to posttest (6-8 weeks))
研究者
Sarah Bannon
Assistant Professor
Icahn School of Medicine at Mount Sinai