Enrollment in the FIT Teens program, which began in January 2018, was paused in March 2020 to revise operations manuals, conduct remote treatment sessions to evaluate accuracy and fidelity, obtain regulatory approvals, and train staff on the new procedures.
In response to the COVID-19 pandemic, investigators examined adaptations to the Fibromyalgia Integrative Training for Teens (FIT Teens) randomized controlled trial (RCT). Results indicated that changing the program from in-person to remote was feasible and reported enrollment, retention, and treatment fidelity that were comparable to those receiving the in-person format, according to a study published in Contemporary Clinical Trials Communications.1
FIT Teens is an ongoing 3-arm comparative effectiveness study evaluating whether a neuromuscular exercise training intervention combined with cognitive-behavioral therapy (CBT) was more effective when compared with CBT alone or graded aerobic exercise (GAE) alone. Originally, the trial was designed as an in-person, group-based treatment with assessments performed at baseline, mid-treatment, post-treatment, and 4 follow-up visits (month 3, 6, 9, and 12). However, due to COVID-19 restrictions, modifications, to screening, consent, assessment, and group-based treatments were delivered in a telehealth format.
The FIT Teens study ultimately aims to enroll 420 patients with juvenile fibromyalgia (JFM) aged 12-17 years. Patients are assigned to 1 of 3 active interventions, all of which involve group-based treatment sessions held 2 times per week over 8 weeks. Eligible patients must meet American College of Rheumatology (ACR) criteria for fibromyalgia, have moderate or severe disability (defined as a Functional Disability Inventory [FDI] score of ≥ 13), and a recent pain intensity rating of ≥4/10 on a visual analog scale (VAS).
The primary outcome is functional disability, and the secondary outcome is pain intensity. Investigators also included patient-reported outcome measures regarding coping efficacy, fatigue, mood, and objective measures of strength, physical fitness, and functional biomechanics.
Enrollment, which began in January 2018, was paused in March 2020 for 5 months to revise operations manuals, conduct remote treatment sessions to evaluate accuracy and fidelity, obtain regulatory approvals, and train staff on the new procedures. Patient-reported outcome measures were changed from in-person to remote administration via REDCap. The new remote format was relaunched in July 2020. The pandemic’s impact on participants was evaluated using the 16-item subscale from the COVID-19 Adolescent Symptom and Psychological Experience Questionnaire (CASPE), which determined the effects of the pandemic and restrictions on social, family, and academic functioning.
Thus far, trial metrics have reported a consistent rate of enrollment (6.5 participants per month pre-pandemic vs 6.6 participants per month since August 2020), strong attendance of the remote sessions, and high retention rates after remote adaptation protocols were executed. Treatment session attendance was 14.87/16 sessions for those in the remote group compared with 14.67/16 sessions for those who attended in person pre-pandemic. Of the families asked about preferences for treatment format going forward, 100% of parents and caregivers preferred a remote format moving forward, citing lower cost and time of transportation, as well as ease of family schedules. Fidelity was maintained similarly in both in-person (98.4%) and remote (99.7%) formats. Adverse events were also similar in both frequency and nature of events, except for unrelated respiratory adverse events, in both remote and in-person groups.
“This paper described modifications to the implementation of the FIT Teens RCT that allowed the trial to resume enrollment, maintain retention, and ensure participant safety in a manner consistent with trial implementation prior to the pandemic,” investigators concluded. “At the completion of the trial, it is hoped that this transparency in reporting will allow clarity in the interpretation of trial results and establish the foundation for dissemination efforts if the study hypotheses are supported.”
Kashikar-Zuck S, Barnett KA, Williams SE, et al. FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations in response to the COVID 19 pandemic. Contemp Clin Trials Commun. 2022;30:101039. Published 2022 Nov 29. doi:10.1016/j.conctc.2022.101039