Abstract
Background
Self-management approaches in people with Parkinson's disease (PD) have potential to improve patient outcomes and reduce complications leading to hospital admissions. We aimed to evaluate the clinical and cost-effectiveness of the UCL Live Well with Parkinson's toolkit, a facilitated self-management intervention for people with PD.Methods
This two-arm randomised controlled trial in England (Trial Registration: ISRCTN92831552) recruited community-dwelling people with PD from NHS sites and self-referral. They were randomly assigned to the intervention or treatment as usual (TAU), and assessed at baseline, 6- and 12-month follow-up. The primary outcome was the PDQ-39 score, a PD-specific health-related quality of life measure, at 12-months with planned subgroup analyses. Secondary outcomes included non-motor and motor activities of daily living (MDS-UPDRS part I&II), utility values and QALYs derived from the EQ-5D-5L, and total health and social care costs over 12-months. The economic evaluation was based on cost-utility analysis using cost per QALY. All assessors were blinded to group allocation. Analysis was by intention to treat.Findings
166 participants were randomised to the intervention and 180 to TAU, with 12-month follow-up assessments available in 141 (84.9%) and 164 (91.1%), respectively. The primary endpoint (PDQ-39 score) was similar for patients in the intervention and TAU groups (-1.03; 95% CI (-3.03 to 0.97)). Subgroup analyses of PDQ-39 scores in underserved groups however favoured the intervention (-4.0; 95% CI (-6.8 to -1.1)). The combined MDS-UPDRS part I + II score was improved in the intervention compared to the TAU group (-2.61; 95% CI (-4.58 to -0.64)). QALYs were not different between groups (0.018; 95% CI (-0.006 to 0.042) but total health and social care costs over 12-months were lower in the intervention group compared to TAU (-£1282; 95% CI (-£2700 to -£118)), driven mainly by reduced unplanned hospital admissions. Adverse events were similar in both groups. The Live Well with Parkinson's intervention alongside TAU was 99% cost-effective compared to TAU at a decision threshold of £20,000 per QALY and 98% at £30,000.Interpretation
The UCL Live Well with Parkinson's toolkit did not significantly improve health-related quality of life scores overall but improved activities of daily living and reduced health-care costs in comparison to TAU, mainly through reduced unplanned hospital admissions.Funding
National Institute for Health and Care Research RP-PG-1016-20001.