RECOVER-ENERGIZE Platform Protocol_Appendix B (Structured Pacing (PEM))

Duke University300 enrolled

Overview

This is a platform protocol designed to be flexible so that it is suitable for a range of interventions and settings within diverse health care systems and community settings with incorporation into clinical COVID-19 management programs and treatment plans if results achieve key study outcomes. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating interventions to address and improve exercise intolerance and post-exertional malaise (PEM) as manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC). The focus of this protocol is to assess interventions that can improve exercise capacity, daily activities tolerance, and quality of life in patients with PASC.

Study interventions will be added to the platform protocol as appendices. Each appendix will leverage all elements of the platform protocol, with additional elements described in the individual appendix. Study intervention appendices may be added or removed according to adaptive design and/or emerging evidence. The platform protocol enrolls participants who meet study eligibility criteria. After completing initial screening assessments, eligible participants are assigned to one of the study intervention appendices that are actively enrolling. Participants must meet certain criteria within a specific appendix in order to be included in that appendix. Once assigned to an appendix, eligible participants are randomized to either the study intervention group or a control group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Interventions

Structured PacingBEHAVIORAL

Participants in this group will complete weekly pacing sessions for 12 weeks. Pacing sessions will last about 30 minutes, as tolerated. Each participant will meet with a provider 'pacing coach' who has received study-specific education about PEM and how to create and manage pacing strategies for participants. Sessions include PEM symptom and trigger assessment; task, function and activity analysis; adaptations and modifications.

Usual CareOTHER

Participants in this group will receive basic education about PEM with a weekly call by site study staff for support and communication.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

• See NCT06404047 for RECOVER-ENERGIZE: Platform Protocol level inclusion and exclusion criteria which applies to this appendix Additional Appendix B (Structured Pacing (PEM)) Level Inclusion Criteria: 1. Participant identifies new PEM following a SARS-CoV-2 infection that has persisted for at least 12 weeks and is still present at the time of consent 2. Score of 2 or greater for both frequency and severity for any of the first 5 questions on the Screening mDSQ-PEM AND Answer of YES to either item 7 or 8 on Screening mDSQ-PEM, and response of \>14 h in item 9. or Score of 3 or greater on any severity question(regardless) and answer of YES to either item 7 or 8 on the Screening mDSQ-PEM, and response of \>14h in item 9. Additional Appendix B (Structured Pacing (PEM)) Level Exclusion Criteria: 1. Inability to attend in-person screening visit or participate in weekly visits (in-person \[≥ 1\] and remote) 2. Participant was previously enrolled in Appendix A of this protocol and has NOT completed the full study follow-up period of Appendix A

Outcomes

Primary Outcomes

Change in frequency of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)

Symptom frequency is rated on a 5-point Likert scale: 0 = none of the time, 1 = a little of the time, 2 = about half the time, 3 = most of the time, and 4 = all of the time.

Time frame: Baseline, week 12 (End Of Intervention (EOI)), month 6 (End of Study (EOS))

Change in severity of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)

Symptom severity is rated on a 5-point Likert scale: 0 = symptom not present, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe.

Time frame: Baseline, week 12 (EOI), month 6 (EOS)

Change in duration of PEM symptoms, as measured by the Modified DePaul Symptom - Post-Exertional Malaise questionnaire (mDSQ-PEM)

Time frame: Baseline, week 12 (EOI), month 6 (EOS)

Secondary Outcomes

Change in PASC symptoms, as measured by the PASC Symptom Questionnaire

The PASC Symptom Questionnaire is a 33-question survey for self-reporting multiple PASC-related symptoms across multiple systems.