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Response heterogeneity in a randomized controlled trial of telerehabilitation interventions among adults with
Matthew Plow1, Robert W Motl2, Marcia Finlayson3
1Frances Payne Bolton School of Nursing, Case Western Reserve University, USA.
Introduction:
Telerehabilitation may be effective on average but is not equally effective among all people with multiple sclerosis (MS). Thus, the purpose of this secondary analysis of a randomized controlled trial was to explore whether baseline characteristics of participants with MS influence fatigue and physical activity outcomes of three telerehabilitation interventions.
Methods:
Participants were randomized to contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM+). The 12-week interventions were delivered over the phone. Sociodemographic (age and income), clinical (comorbidities, mental function and physical function), psychosocial (self-efficacy, outcome expectations and goal-setting), and behavioural baseline characteristics (step count and fatigue self-management behaviors) were used in a moderated regression analysis and a responder analysis to examine their influence on the Fatigue Impact Scale (FIS) and Godin Leisure-Time Exercise Questionnaire (GLTEQ) at post-test (i.e. immediately post-interventions).
Results:
No interactions terms were statistically significant in the moderation analysis. However, the responder analysis showed that baseline psychosocial characteristics and mental function were significantly different (p < 0.05) between responders and non-responders. Specifically, non-responders on the FIS at post-test in the PA-only intervention had significantly lower baseline scores in goal setting for engaging in fatigue self-management behaviours. Also, non-responders on the GLTEQ at post-test in the FM+ intervention had significantly worse baseline scores in mental function.
Discussion:
Further research is needed to understand the complex relationship among baseline characteristics, telerehabilitation and response heterogeneity. We discuss how research on examining response heterogeneity may be advanced by conducting mega-clinical trials, secondary analyses of big data, meta-analyses and employing non-traditional research designs.
Trial Registration:
Clinicaltrials.gov (NCT01572714).
