Kayıt Tabanlı RCT (A-LISTS) ile İnme Sonrası Kişiye Özel Takip Hizmetinin Fizibilite Çalışması

Özet (abstract)

After stroke, people report ongoing health challenges to national registries without any follow-up. We aimed to assess the feasibility of a co-designed, registry-initiated, follow-up service provided by hospitals and tailored for people reporting health-related challenges between 90 and 180 days after stroke compared with usual care. Multicentre, prospective, parallel two-group, feasibility randomised controlled trial with a blinded design. Hospitals participating in the Australian Stroke Clinical Registry were invited to participate. The inclusion criteria for registrants included reporting health challenges (extreme problems on any EQ-5D-3L dimension or a Visual Analogue Scale score ≤60), willing to be contacted for research and community-dwelling. Registry staff conducted baseline assessments via telephone. Participants were randomised 1:1 to the intervention or control group, stratified by age (<65 years, 65+ years) and sex (male, female). The intervention group received a tailored phone assessment and could have ongoing support for 12 weeks from a trained stroke clinician (nurse/allied health) from their treating hospital. The control group received no additional support. Blinded registry staff completed the outcome assessment 12–14 weeks post-randomisation. All participants were invited to complete an online satisfaction survey. Feasibility outcomes included measures of acceptability related to hospital and participant recruitment, retention, and completion rates, and service satisfaction. Potential effectiveness: change in health challenges. Of 238 registrants screened between April 2023 and November 2024 from four participating hospitals, 185 were deemed eligible. Among those who were eligible, 68 were consented (37%), and 62 were randomised (91% retention). Median age of randomised participants was 67 years and 34% were female. Of those randomised, 51 completed the outcome assessment (86% completion after excluding three deaths), and 45 (88%) completed the satisfaction survey. For pre-specified feasibility outcomes, all but one ( 40% consented if eligible ) were met. There were no serious adverse events attributed to trial participation. Both groups reported a positive experience. Most intervention participants enjoyed their involvement (88%), and 87% would recommend participation to others. A positive change in health challenges was achieved in 32% intervention participants, meeting the pre-specified feasibility target of 30%. This feasibility trial provides evidence for a novel registry-based follow-up service and will inform a future fully powered effectiveness trial. Australian New Zealand Clinical Trials Registry (ACTRN12622001015730), registered 20th July 2022. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383784

Yazarların özeti; kaynağından alınmıştır. Pilot and Feasibility Studies, 2026 · DOI ↗