A telephone-delivered approach including cognitive behavioral approaches (CBA) and personalized exercise programs (PEP) was shown to produce and maintain both statistically and clinically significant reductions in the severity and impact of fatigue for patients with rheumatic diseases. Investigators urge rheumatologists to utilize this treatment method in routine clinical practice, according to a study published in The Lancet.1
“Chronic fatigue is a poorly managed problem in people with inflammatory rheumatic diseases,” investigators stated. “CBA and PEP can be effective, but they are not often implemented because their effectiveness across the different inflammatory rheumatic diseases are unknown and regular face-to- face sessions are often undesirable, especially during a pandemic. We hypothesized that remotely delivered CBA and PEP would effectively alleviate fatigue severity and life impact across inflammatory rheumatic diseases.”
The LIFT study (NCT03248518) was a multicenter, controlled, open-label, parallel-group trial that evaluated usual care alongside a telephone-delivered CBA or PEP against a usual care approach in hospitals in the United Kingdom (England and Scotland). Eligible patients, randomized 1:1:1, had a stable inflammatory rheumatic disease and reported clinically significant, persistent fatigue. A web-based randomization system was used to assign treatment allocation and CBA and PEP sessions were delivered over a 6-month period by trained health professionals. Primary outcomes included fatigue severity, as assessed by the Chalder Fatigue Scare, and impact (Fatigue Severity Scale) at week 56.
Between September 2017 and September 2019, 367 patients were randomly assigned to either PEP (n = 124), CBA (n = 121), or usual care (n = 122). The mean age was 57.5 years and 75% (n = 274 ) of participants were women. Most patients (n = 202, 55%) had a diagnosis of rheumatoid arthritis, 78 (21%) had connective tissue disease, 72 (20%) had axial spondyloarthritis, and 14 (4%) had another inflammatory rheumatic disease.
The Chalder Fatigue Scale included a total of 101 participants in the PEP cohort, 107 in the CBA cohort, and 107 in the usual care group. Those in the PEP and CBA groups had both significantly better improved fatigue severity (Chalder Fatigue Scale; PEP: adjusted mean difference −3 03 [97·5% CI −5·05 to −1·02]p=0 0007; CBA: −2 36 [–4·28 to −0·44]p=0 0058) and fatigue impact (Fatigue Severity Scale; PEP: −0 64 [–0·95 to −0·33]p<0 0001; CBA: −0 58 [–0·87 to −0·28]p<0 0001) when compared with those who received usual care alone. No serious adverse events were reported.
Limitations included the lack of full masking due to the need to engage people in behavioral changes. Further, the comparison group was usual care because the intention was to determine whether interventions made an impact on current practice. However, detection bias was minimized by masking investigators and analysts to allocation. Potential nocebo effects in relation to the usual care cohort were not. Patients in the usual care group were given educational materials that were previously substantial linked to positive impacts and were currently related to improved outcomes when compared with the baseline score and equivalent attrition rates. Lastly, while 12% of participants discontinued therapies, these stats were in line with previous data.
“CBA and PEP delivered by telephone provided statistically and clinically significant reductions in fatigue severity and impact for a wide range of patients whose disease was otherwise stable,” investigators concluded. “The treatments were well tolerated, their benefits were maintained 6 months after treatment completion , and they were successfully delivered by members of the rheumatology multidisciplinary teams after specialist training.”
Martin KR, Bachmair EM, Aucott L, et al. Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT). BMJ Open. 2019;9(1):e026793. Published 2019 Jan 30. doi:10.1136/bmjopen-2018-026793