Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05658536
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2022-12-16
Brief Title:
The COPE Study Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID-19
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
The COPE Study Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 eg 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
1 To examine the feasibility and acceptability of a telemedicine group-based intervention for improving symptom management and coping in adults with Post-COVID
2 To examine initial effects of a telemedicine group-based intervention on Post-COVID symptom management and adaptive coping
3 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
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 eg 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
1 To examine the feasibility and acceptability of a telemedicine group-based intervention for improving symptom management and coping in adults with Post-COVID
2 To examine initial effects of a telemedicine group-based intervention on Post-COVID symptom management and adaptive coping
3 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None