Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.
Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).
Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.
ACTRN12624000658516.
Objetivo principal: Analizar si una intervención de enfermería de información sobre la cirugía y el circuito quirúrgico, tendría como efecto la disminución del nivel de ansiedad en el familiar del paciente quirúrgico programado. Metodología: Ensayo clínico controlado no aleatorizado. Se efectúa la comparación del nivel de ansiedad entre los familiares pertenecientes al grupo control (con intervención estándar preexistente) respecto a los del grupo intervención (sometidos a la nueva intervención de enfermería). Se utiliza un instrumento validado como el inventario de ansiedad estado-rasgo (STAI) para medir el nivel de ansiedad. Resultados principales: Participaron en el estudio 76 familiares, 37 en el grupo control y 39 en el grupo intervención. Ambos grupos eran comparables respecto a sus características basales. Se observa una disminución estadísticamente significativa en la ansiedad situacional durante el postoperatorio en el grupo intervención respecto al grupo control. Conclusión principal: Una intervención de enfermería de información sobre la cirugía y el circuito quirúrgico reduce la ansiedad situacional del familiar del paciente quirúrgico programado.