The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID-19

Post-COVID-19 Syndrome Clinical Trial

Official title:

The COPE Study: Pilot Intervention to Improve Symptom Self-management and Coping in Adults With Post COVID

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05658536
• Other study ID #: STUDY00016345
• Status: Completed
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. Resident of Washington state

3. Diagnosis of a Post-COVID condition

4. Able to read, speak, and understand English

5. Availability of a telephone and internet access

Exclusion Criteria:

1. Severe cognitive impairment

2. Currently receiving other psychosocial treatments primarily for any Post-COVID symptom(s) or problem(s)

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

Intervention

Behavioral:
• 6-Week Self-Management Group
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.

Locations

Country	Name	City	State
United States	University of Washington, Ninth and Jefferson Building	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Depressive Symptoms	Change in Mood will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 8b. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of 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)
Secondary	Anxiety Symptoms	Change in Anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of anxiety.	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)
Secondary	Fatigue	Change in Fatigue will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of 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)
Secondary	Sleep Disturbance	Change in Sleep Disturbance will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of 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)
Secondary	Perceived Cognitive Difficulties	Change in Perceived Cognitive Difficulties will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function - Abilities Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of 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)
Secondary	Self-Efficacy	Change in Self-Efficacy will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Chronic Conditions - Managing Symptoms Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of 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)
Secondary	Psychosocial Functioning	Change in Psychosocial Functioning will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of ability to participate in social roles and activities.	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)
Secondary	Pain Interference	Change in Pain Interference will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 8a. When assessed via online survey, responses will be summed to form a total T-score score based on normative data. Higher scores indicate higher self-reported levels of 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)
Secondary	Impression of Change	Impression of Change will be measured with the Patient Global Impression of Change scale. Higher scores on this one-item scale indicate higher self-reported levels of impression of change.	Collected via online survey at post-treatment (up to 2 months after Tx Session 6)
Secondary	Symptoms and Impact of Post-COVID	Symptoms and Impact of Post-COVID will be measured with the Long COVID Symptom and Impact Tools (ST and IT). When assessed via online survey, responses from the Long COVID Symptom Tool (ST) items will be scored as a simple count (yes/no). Higher scores indicate higher self-reported levels of symptoms of Post-COVID. Responses from the Long COVID Impact Tool (IT) will be summed. Higher scores indicate higher self-reported levels of 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)