Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
追踪信息 | |||
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首次提交日期 ICMJE | September 28, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 4, 2018 | ||
预计研究开始日期 ICMJE | October 1, 2018 | ||
预计主要完成日期 | August 31, 2020 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Feasibility of recruitment (ability to recruit dyads)[ Time Frame: Baseline ] Feasibility of recruitment will be determined by reporting number of dyads Number dyads who agree to participate Feasibility of intervention delivery (ability to delivery intervention to dyads)[ Time Frame: Feasibility of program delivery will be measured at 6 weeks ] Number of dyads who complete the post-intervention assessment. Credibility and expectancy questionnaire[ Time Frame: Baseline ] This measure will assess participants' belief that the intervention (or control) will be helpful. Client Satisfaction Questionnaire[ Time Frame: post intervention (6 weeks after baseline) ] This measure will assess participants' satisfaction with participation in the study. |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers | ||
正式标题 ICMJE | Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers | ||
简要概况 | 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. |
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详细说明 | 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. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
160 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | August 31, 2020 | ||
预计主要完成日期 | August 31, 2020 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - Male and female out patients, age 50 years or older - Have a nonmalignant chronic pain for more than 3 months - Has a documented MCI diagnosed by a neurologist - Able to perform a 6-minute walk test - Free of concurrent psychotropic or pain medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic or pain medication for a minimum of 6 weeks and willing to maintain a stable dose - Cleared by a medical doctor for study participation Exclusion Criteria: - Diagnosed with a medical illness expected to worsen in the next 6 months (e.g. malignancy) - Serious mental illness or instability for which hospitalization may be likely in the next 6 months - Current suicidal ideation reported on self-report - Lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder - Current substance abuse or dependence and current substance use disorder, within the past 6 months - Practice of yoga/meditation, or other mind body techniques that elicit the RR, once per week for 45 minutes or more within the last 3 months or less - Regular use of Fitbit in the last 3 months - Unable to walk without use of assistance (e.g. walk, cane, wheelchair) | ||
性别 |
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年龄 | 最小年龄:18 Years ,最大年龄:N/A | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | United States | ||
管理信息 | 数据检测委员会 | No | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Ana-Maria Vranceanu, PhD,Massachusetts General Hospital | ||
研究赞助商 ICMJE | Massachusetts General Hospital | ||
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研究员 ICMJE |
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PRS 账户 | Massachusetts General Hospital | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |