Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Feasibility of Recruitment (Ability to Recruit Dyads)
研究概览
简要总结
The investigators will compare a dyadic intervention (Recovering Together) with an attention placebo educational control in dyads of patients with acute neurological illnesses and their caregivers at risk for chronic emotional distress. The primary aim of this study is to determine the feasibility, credibility, and satisfaction with Recovering Together. The second aim is to show proof of concept for sustained improvement in emotional distress, post traumatic stress (PTS), resiliency and interpersonal communication outcomes in patients and caregivers.
详细描述
The investigators aim to improve the care of patients (pts) admitted to the Neuroscience Intensive Care Unit (NICU) and their family caregivers (cgs) by conducting a pilot feasibility randomized controlled trial (RCT; N=80 dyads; 60 completers) of the dyadic resiliency program ("Recovering Together") to prevent chronic emotional distress in both pts and their cgs. Eligible dyads include adult, English speaking pts with acute neurological injury (ANI) admitted to the NICU, cleared medically and cognitively for participation by the nursing team, and their primary cgs. Dyads who are randomly assigned to "Recovering Together" will receive 6 manualized sessions (2 in person at hospitalization and 4 through live video after discharge, to reduce burden and facilitate access to care) led by a clinical psychologist. Dyads who are randomly assigned to the attention placebo educational control condition will receive 6 manualized sessions (2 in person and 4 through live video with a clinical psychologist), modeled after the Recovering Together program that will control for the dose of the intervention and support from therapist. Dyads will complete assessment surveys before, after the intervention and 3 months later. Clinical data on demographics, diagnosis, ANI severity, and any medical complications will be extracted from electronic health records.
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
- Single (Participant)
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
- •Male and female patients, 18 years or older
- •English fluency and literacy
- •Access to high speed internet for video sessions
- •Patient with an informal cg (family or friend who provides unpaid care) available and willing to participate
- •Hospitalized with an acute brain injury within 1-2 days when first approached, OR the primary caregiver of a patient currently admitted with an acute brain injury
- •Either patient or caregiver within the dyads screens in for depression, anxiety, and/or PTSD
排除标准
- •Permanent or severe cognitive impairment severe enough to impede participation - This will be determined by nurses through an assessment conducted as part of usual care (MMSE).
- •Dyads where the patient is anticipated to die or to never be able to participate due to medical sequelae.
结局指标
主要结局
Feasibility of Recruitment (Ability to Recruit Dyads)
时间窗: Baseline
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)
时间窗: Feasibility of program delivery will be measured at 6 weeks
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Credibility and Expectancy Questionnaire
时间窗: Baseline
This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy.
Client Satisfaction Questionnaire
时间窗: post intervention (6 weeks after baseline)
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
次要结局
- Dyadic Relationship Scale(Baseline, post treatment, 3-month follow-up)
- Hospital Anxiety and Depression Scale(baseline to posttest to 3 months follow up)
- Post Traumatic Checklist(baseline to posttest to 3 months follow up)
- Measures of Coping Style Part A(baseline to posttest to 3 months follow up)
- Cognitive and Affective Mindfulness Scale Revised(baseline to post test to 3 months follow up)
研究者
Ana-Maria Vranceanu, PhD
Director of Integrated Brain Health Clinical and Research Program
Massachusetts General Hospital