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The COVID-19 pandemic had a major impact on both healthcare systems and research. In the beginning of the pandemic, many research institutions and funding agencies recommended a moratorium on conducting research and enrolling participants until protocol changes could be made to protect participant safety.
In a paper appearing in Contemporary Clinical Trials Communications, Linda Ehrlich-Jones, PhD, RN, Associate Director of the Center for Rehabilitation Outcomes Research at Shirley Ryan AbilityLab, and colleagues, outline changes they made to their protocol for a fatigue intervention for people with lupus in response to the pandemic.
“Our first concern related to the pandemic was for our participants’ and researchers’ safety,” says Ehrlich-Jones, who is also a Research Professor of Physical Medicine and Rehabilitation in the Northwestern University Feinberg School of Medicine. “We knew that major changes needed to be made and we were anticipating they would significantly delay the study or cause participants to drop out, but thankfully, neither of those happened and we were able to continue the study with modifications to our protocol.”
The study, called the Lupus Intervention Fatigue Trial (LIFT), is a 12-month, phase II, randomized, controlled trial to compare the effectiveness of a motivational interviewing-based intervention versus an educational program (control group) to reduce fatigue in people with lupus.
Participants randomized to the motivational interviewing intervention had one in-person baseline coaching session and three phone calls at 1.5 months, 3 months and 6 months after the baseline intervention visit. Participants randomized to the educational control group have four phone calls: one at the beginning of the study, and follow-up calls at 1.5 months, 3 months and 6 months after the first call. All participants provided consent and underwent physical assessments during in-person clinic visits before the pandemic.
Twenty-five participants were enrolled in the study (of a target total enrollment of 200) when the pandemic hit. On March 17, 2020, a moratorium on recruitment was placed by Northwestern University and Northwestern Medicine. Due to new safety requirements, such as social distancing, Ehrlich-Jones’ research team halted in-person interaction with participants, and made several changes based on the Northwestern University’s Institutional Review Board.
Major changes included electronic consent, remote intervention baseline visits for those in the intervention arm, self-report outcome measures at home via emailed weblinks, and telemedicine physician assessment visits. The collection of labs (blood, urine, vital signs) presented the largest challenge since this required an in-person visit to a laboratory. The study team elected to delay this up to one month after the physician assessment. All follow-up visits were completed, and no participants withdrew from the study.
“Modifications to the LIFT study protocol allowed us to continue the study while ensuring researcher and patient safety during a global pandemic,” says Ehrlich-Jones. “The changes we made, also happened to improve efficiency of the study, like X and Y, and we have elected to keep those changes even as restrictions due to the pandemic lifted.”
R. Ramsey-Goldman, H. Milaeger, J.S. Chmiel, A. Chung, D. Erickson, A. Kenney and L. Rosiles of Northwestern University and D. Kinnett-Hopkins of the University of Michigan and Northwestern University are co-authors on the paper.
This research is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health (award number R01AR071091-02S1).
