The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID-19
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2022
CompletedFirst Posted
Study publicly available on registry
December 20, 2022
CompletedStudy Start
First participant enrolled
January 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2024
CompletedMarch 29, 2024
March 1, 2024
1 year
December 16, 2022
March 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Intervention Acceptability
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.
Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Appropriateness
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.
Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Intervention Feasibility
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.
Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Secondary Outcomes (10)
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)
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)
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)
- +5 more secondary outcomes
Study Arms (2)
6-Week Self-Management Group
ACTIVE COMPARATOR6-week telemedicine group-based intervention designed to improve symptom management and coping in adults with Post-COVID. The intervention consists of six weekly group sessions that are 1.5 hours long. Group size is 8-10 participants.
6-Week Waitlist Group
NO INTERVENTION6-week waitlist period during which participants will complete study assessments. After completing the study, waitlist participants will be offered the active intervention.
Interventions
The goal of the 6-session group-based intervention for patients with Post-COVID is to teach patients behavioral strategies known to be helpful in managing several common Post-COVID symptoms, including fatigue, memory and attention issues, poor sleep, breathlessness, coping with anxiety and uncertainty, and stress management. It is currently available to patients who are seen in the Post-COVID-19 Rehabilitation and Recovery Clinic at UW and the Post-COVID-19 Clinic in VAPSHCS Rehabilitation Care Services.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe cognitive impairment
- Currently receiving other psychosocial treatments primarily for any Post-COVID symptom(s) or problem(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington, Ninth and Jefferson Building
Seattle, Washington, 98104, United States
Related Publications (1)
Knowles LM, Grewal M, Drever SA, Hoffman JM, Friedly JL, Herring TE. A pilot randomized controlled trial of a telemedicine psychosocial intervention to improve symptom management in adults with long COVID: the COPE study protocol. Pilot Feasibility Stud. 2024 Jun 17;10(1):93. doi: 10.1186/s40814-024-01515-2.
PMID: 38886814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tracy Herring, PhD
University of Washington
- PRINCIPAL INVESTIGATOR
Lindsey Knowles, PhD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Acting Assistant Professor, School of Medicine
Study Record Dates
First Submitted
December 16, 2022
First Posted
December 20, 2022
Study Start
January 18, 2023
Primary Completion
January 30, 2024
Study Completion
January 30, 2024
Last Updated
March 29, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The data used for the analyses for any papers published will become available to interested researchers by request after that article is published. Those data will continue to be available for at least five years following the publication of the article.
- Access Criteria
- We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
We will make available to interested researchers a data file containing de-identified data used for each published article at the time the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all variables used in the published article and a list of the variables in the data file (along with variable labels) and send to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) the dataset (as an SPSS.sav file). Note, though, even though any data files that we share will be stripped of identifiers prior to release for sharing, it remains possible those who access the data could potentially use deduction to identify participants with unusual characteristics or combinations of unusual characteristics.