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

Duke University

Status: Enrolling

Conditions: Long Covid19; Long Covid-19; Long COVID

Treatments: Other: Usual Care; Behavioral: Structured Pacing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06404073

NHLBI Grant to RTI (Other Grant/Funding Number)

OT2HL156812 (U.S. NIH Grant/Contract)

Pro00112409_B

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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, or response of >14 h 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Structured Pacing (PEM)

Experimental group

Description:

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.

Treatment:

Behavioral: Structured Pacing

Usual Care

Other group

Description:

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

Treatment:

Other: Usual Care