Investigating Dyadic Expectations About ARF Survivorship (IDEAS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Symptoms of Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
The purpose of this observational study is to understand how adults who survive acute respiratory failure (ARF) and the people (usually family) who support ARF survivors after returning home think about the first 6 months of recovery. The study aims to find out if expectations about the recovery process after ARF are associated with mental health symptoms in both survivors and the survivor's care partners. Study participants will complete 3 surveys over 6 months. These surveys ask questions about participants' future expectations, feelings, and mood. Surveys can be completed online, over the phone, or on paper.
详细描述
The overarching objectives of the Investigating Dyadic Expectations about ARF Survivorship (IDEAS) cohort study are to learn how expectations about ARF survivorship are related to dyadic mental health symptoms and dyadic coping. Specifically, the study aims are:
- Aim 1: To determine whether health expectations and self-efficacy after acute respiratory failure (ARF) are associated with mental health outcomes in survivor-care partner dyads.
- Aim 2: To assess whether concordant expectations within survivor-care partner dyads are associated with better dyadic coping (primary outcome) and exploratory secondary outcomes.
The term dyadic coping refers to the ways two people interact as the pair manage illness-related stressors. Concordant expectations within dyads, also called shared appraisal, refers to both members of a dyad being "on the same page", and is hypothesized to lead to better dyadic coping behaviors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient Inclusion Criteria:
- •≥18 years old
- •Meets study definition of ARF:
- •The study defines ARF as meeting 1 of the following 3:
- •Mechanical ventilation via an endotracheal tube ≥24 consecutive hours OR
- •Non-invasive ventilation (CPAP, BiPAP) ≥24 consecutive hours that is not for obstructive sleep apnea or other stable use OR
- •High flow nasal cannula with fraction of inspired oxygen (FIO2)≥.5 and flow rate ≥ litres per minute (LPM) for ≥24 consecutive hours.
- •Occasional rest periods of ≤1 hour are not deducted from the calculation of consecutive hours. Patients who are intubated for mental status or airway obstruction are not eligible unless they have simultaneous ARF.
- •Survival to hospital discharge to home
- •Speaks or reads English or Spanish
- •Identifies an adult who is expected to act as a primary care partner for at least the next 6 months.
排除标准
- •Pre-existing cognitive impairment (IQ-CODE >3.6)
- •Residing in a medical institution at hospital discharge
- •Receiving hospice care or life expectancy <6 months
- •Homelessness or recent history of psychosis
- •Care Partner Inclusion Criteria:
- •≥18 years old
- •Speaks or reads English or Spanish
- •Care Partner Exclusion Criteria:
- •Pre-existing cognitive impairment (IQ-CODE >3.6)
研究组 & 干预措施
ARF Survivor-Care Partner Dyads
The study will recruit 235 dyads of adult ARF survivors and care partners. The term "care partner" refers to an individual (e.g. family member or friend) that supports the survivor at home.
干预措施: Dyadic expectations about the ARF survivor's perceived health 6 months after hospital discharge (Other)
ARF Survivor-Care Partner Dyads
The study will recruit 235 dyads of adult ARF survivors and care partners. The term "care partner" refers to an individual (e.g. family member or friend) that supports the survivor at home.
干预措施: Self-efficacy (Other)
ARF Survivor-Care Partner Dyads
The study will recruit 235 dyads of adult ARF survivors and care partners. The term "care partner" refers to an individual (e.g. family member or friend) that supports the survivor at home.
干预措施: Concordant expectations/shared appraisal of ARF survivor's health 6 months after hospital discharge (Other)
结局指标
主要结局
Symptoms of Anxiety and Depression as Assessed by the Hospital Anxiety and Depression Scale (HADS)
时间窗: 3 and 6 months after ARF survivor's ICU discharge
Symptoms of anxiety and depression in both members of enrolled dyads will be assessed at 3- and 6-month follow-up assessments using the HADS. The HADS has 14 items. Scores for the anxiety and depression subscales range from 0 - 21 with scores ≥8 reflective of clinically significant symptoms.
Dyadic Coping as Assessed by the Dyadic Coping Inventory (DCI)
时间窗: 3 and 6 months after ARF survivor's ICU discharge
Dyadic coping will be assessed at 3- and 6-month assessments using the Dyadic Coping Inventory (DCI).The DCI contains 37 items that will be answered by both dyad members. Items are rated on a 5-point scale ranging from 1 ("Very rarely") to 5 ("Very often") and the total DCI score is the sum of items 1 through 35 after reverse coding negatively keyed items. There are established cut-off scores to evaluate dyadic coping as follows: DCI total score \< 111 reflects below average dyadic coping, DCI between 111-145 reflects normal dyadic coping, and DCI total score \> 145 reflects above average dyadic coping.
次要结局
- Health-related Quality of Life as Measured by the European Quality of Life 5-Domain 5-level Questionnaire (EQ-5D-5L)(3 and 6 months after ARF survivor's hospital discharge)
- Social Isolation as Measured by Social Isolation Score(3 and 6 months after ARF survivor's hospital discharge)
- Symptoms of Post Traumatic Stress as Measured by the Impact of Events Scale-Revised (IES-R)(3 and 6 months after ARF survivor's hospital discharge)
- Financial Toxicity as Assessed by Qualitative Questions(3 and 6 months after ARF survivor's hospital discharge)