Abstract
Keywords: Digital health; Anterior cruciate ligament; Behaviour change Purpose: To evaluate the feasibility of TRAK-ACL, a digital health intervention that provides health information, personalised exercise plans and remote clinical support combined with treatment as usual (TAU), for people following anterior cruciate ligament (ACL) reconstruction. Methods: The study design was a two-arm parallel randomised control trial (RCT). Eligible participants were adults, English speakers, had undergone ACL reconstruction within the last 12 weeks, had access to the internet and could provide informed consent. Recruitment took place at 3 sites in the UK. TRAK-ACL intervention was an interactive website informed by behaviour change technique combined with TAU. The comparator was TAU. Outcomes were: recruitment and retention, completeness of outcome measures at follow-up, fidelity of intervention delivery, and engagement with the TRAK-ACL website. Individuals were randomised using a computer-generated random number sequence. Blinded assessors allocated groups and collected outcome measures. Results: Fifty-nine people were assessed for eligibility and 51 were randomised, 26 were allocated to TRAK-ACL and 25 to TAU. Retention was 44 and 40 at 3 and 6 months. All eligible participants were identified at two of the participating sites. All outcome measures were completed fully at 6 months except the Client Service Receipt Inventory. Two patients in each arm did not receive the treatment they were randomised to. Engagement with TRAK-ACL intervention was a median of 5 logins (Inter Quartile Range 3-13), over 18 weeks (Standard Deviation 12.2). Conclusion(s): The feasibility of TRAK-ACL has been demonstrated and would be suitable for evaluation of effectiveness in a fully powered RCT. Further investment in the intervention would be required. Impact: This research provides an evidence-based digital health intervention that reflects the expertise of physiotherapy led ACL rehabilitation. TRAK ACL, could go some way to overcoming the variations in care at a national level and improving access to the information, exercises and benchmarks that are needed at all stages of ACL rehabilitation. TRAK ACL has the potential to improve access to optimal care across the NHS. Technical work to increase its functionality will be a part of its ongoing impact. Funding acknowledgements: NIHR Clinical Doctoral Research Fellowship.
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