Background: Traumatic brain injury (TBI) often leads to persistent difficulties with cognitive, emotional and vocational functioning, as well as reduced community integration and quality of life. Although many receive targeted rehabilitation services in the acute and sub-acute phase, studies have documented high levels of unmet needs for health care services in the chronic phase of TBI, frequently in emotional, vocational and cognitive domains. In the chronic phase, services are often provided in a primary care context, and should thus be tailored to the individual difficulties, including perspectives such as participation, community reintegration, social support and family functioning. Research on effective treatment options delivered in the community setting is, however, lacking. An innovative, home-based and individual goal-oriented intervention program performed in close collaboration with family members was developed in the US by Winter and colleagues. The intervention is currently being evaluated in a Norwegian population, within the context of a universal health coverage and a public health care system. In preparation for a future definite randomized controlled trial (RCT) evaluating the effectiveness of this intervention, the feasibility of the study protocol was assessed in line with recommendations for complex interventions from the Medical Research Council, UK.
Methods: This feasibility trial applied a one group pre-post design, including a baseline assessment (T1) and follow up assessment immediately after the intervention (T2). Six adults with severe TBI (5 males, time since injury 7.5–8.5 years) in metropolitan Oslo, Norway, were recruited and received the intervention. The intervention was manualized and consisted of six in-home visits and two telephone contacts, delivered over a period of 4 months. Three of the participants had participating family members. Primary feasibility objectives were to evaluate (i) recruitment and screening procedures, (ii) baseline and follow-up assessments, (iii) intervention delivery, (iv) order of primary and secondary outcome measures, and (v) acceptability.
Results: Evaluation of the recruitment and screening procedures showed need of inclusion criteria adjustments. Baseline assessment was found to be too time consuming and was abbreviated to decrease participant burden. Intervention delivery was feasible. Outcome measures were reviewed and amendments were deemed necessary. Acceptability was high, with no drop outs. The participants showed high goal attainment at the end of the intervention. All participants said they would be willing to participate in a similar study at a later point in time.
Discussion: The intervention was deemed feasible in a population of severe TBI and preliminary results seem promising. The feasibility trial led to important amendments to inclusion criteria, baseline assessment and outcome measures before commencement of the full-scale RCT. Importantly, results showed high acceptability and high goal attainment at an individual level, strengthening the feasibility and utility of the intervention. The RCT-study recruitment started in June 2018.

A Community-Based Intervention Program in the Chronic Phase of TBI: A feasibility trial for a randomized controlled trial.