The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Intervention Feasibility
研究概览
简要总结
This project is a randomized controlled pilot trial using mixed methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
详细描述
Post-acute sequelae SARS-CoV-2 infection (PASC), also referred to as Post-COVID, is an emerging condition with debilitating symptoms relevant to rehabilitation medicine. Post-COVID has been described as the "next national health disaster". The Centers for Disease Control and Prevention describe Post COVID as a wide range of physical and mental health symptoms lasting four or more weeks after SARS-CoV-2 infection. Some of the most common and disabling symptoms include, fatigue, memory issues, pain-related symptoms, insomnia, and shortness of breath. In addition to these physical symptoms, many patients with Post-COVID report co-occurring mental health concerns, including anxiety and depression. It is believed that over 100 million people worldwide currently experience or have experienced Post COVID. Importantly, this condition can be debilitating and disabling - nearly one in five people reported not working as a direct result of Post COVID.
Psychosocial self-management interventions are a promising treatment for helping people with Post COVID manage their symptoms and engage in adaptive coping. Unfortunately, there is currently no cure for Post COVID, and it is unclear at what timepoint patients will recover or what proportion of patients will recover. Given the variability and chronicity of Post COVID symptoms, self-management interventions could be particularly beneficial. Research on patient populations with similar symptom profiles as Post COVID (e.g., myalgic encephalomyelitis, multiple sclerosis) suggests that psychosocial interventions like self-management can reduce symptom severity and interference and improve coping.
This randomized controlled pilot trial will use quantitative and qualitative methods to examine the feasibility, acceptability, and initial effects of a telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID.
The study objectives include:
- To examine the feasibility and acceptability of a telemedicine group-based intervention for improving symptom management and coping in adults with Post-COVID.
- To examine initial effects of a telemedicine group-based intervention on Post-COVID symptom management and adaptive coping.
- To understand intervention participants' perceptions of the feasibility, acceptability, appropriateness, and perceived effectiveness of the Post-COVID intervention and their recommendations for improving the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age ≥ 18 years
- •Resident of Washington state
- •Diagnosis of a Post-COVID condition
- •Able to read, speak, and understand English
- •Availability of a telephone and internet access
排除标准
- •Severe cognitive impairment
- •Currently receiving other psychosocial treatments primarily for any Post-COVID symptom(s) or problem(s)
结局指标
主要结局
Intervention Feasibility
时间窗: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Feasibility will be measured with the Feasibility of Intervention Measure (FIM). When assessed via online survey, responses from the Intervention Feasibility items will be averaged to create an average score \[1-5\]. A higher score indicates more agreement with intervention feasibility while a lower score indicates less agreement with intervention feasibility.
Intervention Acceptability
时间窗: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Acceptability will be measured with the Acceptability of Intervention Measure (AIM). When assessed via online survey, responses from the Intervention Acceptability items will be averaged to create an average score \[1-5\]. A higher score indicates more agreement with intervention acceptability while a lower score indicates less agreement with intervention acceptability.
Intervention Appropriateness
时间窗: Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Appropriateness will be measured with the Intervention Appropriateness Measure (IAM). When assessed via online survey, responses from the Intervention Appropriateness items will be averaged to create an average score \[1-5\]. A higher score indicates more agreement with intervention appropriateness while a lower score indicates less agreement with intervention appropriateness.
次要结局
- Impression of Change(Collected via online survey at post-treatment (up to 2 months after Tx Session 6))
- Depressive Symptoms(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Symptoms and Impact of Post-COVID(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Anxiety Symptoms(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Self-Efficacy(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Psychosocial Functioning(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Fatigue(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Sleep Disturbance(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Perceived Cognitive Difficulties(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
- Pain Interference(Collected via online survey at pre-treatment (up to 1 month before Tx Session 1) and post-treatment (up to 2 months after Tx Session 6))
研究者
Tracy Herring
Acting Assistant Professor, School of Medicine
University of Washington