Tied by tiredness, a blended care intervention for fatigue after acquired brain injury: study protocol for a multicentre prospective non-randomized patient-preference trial into patient-related outcomes and costs

BACKGROUND: Despite the high prevalence of fatigue after acquired brain injury and the major impact of fatigue on people's lives, evidence-based interventions are scarce. We developed a new personalized blended care intervention, Tied by Tiredness, which was found to be feasible in a pilot study. In this paper, we present the design of a study of patient-related outcomes and the societal costs of the intervention. METHODS: This study is a multicentre prospective nonrandomized patient preference trial with baseline (T0), posttreatment (T1), 3-month (T2) and 6-month (T3) follow-up data. The participants will be 45 adults who have experienced brain injury (stroke or traumatic brain injury) and are seeking treatment for fatigue symptoms. The participants will choose whether to receive Tied by Tiredness or treatment as usual. The Tied by Tiredness intervention consists of a 6-week blended care treatment, which combines experience sampling methodology (participants answer momentary questions about fatigue and their daily lives sent via a phone application) with personalized face-to-face feedback by a health care professional. Treatment as usual entails occupational therapy sessions once a week for 6-8 weeks. Measures of fatigue and secondary outcomes (mood, cognitive complaints, participation, and quality of life) will be collected via questionnaires at each time point. To investigate the changes in fatigue severity from pre- to postintervention and follow-up, a linear mixed-effects model with fatigue severity score (FSS) as the dependent variable and time point (T0, T1, T2, T3) as a within-subject factor will be used. In addition, a cost analysis will be performed from a societal perspective, including both direct medical costs (e.g., intervention costs) and societal costs (e.g., informal care, productivity losses). DISCUSSION: Fatigue after brain injury is multifactorial with high individual variability. We hypothesize that the personalized blended care intervention Tied by Tiredness may be an efficient and effective intervention to reduce fatigue and related problems TRIAL REGISTRATION: Clinical trial number: ID: NL-OMON21265; Overview of Medical Research in the Netherlands (OMON). The trial was first registered in the Overview of Medical Research in the Netherlands (ID: NL-OMON21265) on May 31st, 2021, before recruitment started.