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Background <p>Currently, there is insufficient evidence supporting geriatric home rehabilitation after hospital discharge. Some studies demonstrate a positive effect, but meta-analytic evidence demonstrates uncertainty on the magnitude of the expected effect. Yet, evidence from other populations indicates that home rehabilitation could also be an effective strategy for older persons. Therefore, we aim to evaluate the effectiveness of geriatric home rehabilitation in older persons discharged from the hospital with disability. Given the potential challenges in recruiting participants delivering the intervention, and executing other study procedures in a multi-centre study, we will first carry out a pilot study.</p> Methods <p>The pilot study will commence with an initial start-up phase at two centres: UZ Leuven and CHU UCL Namur, Belgium. Up to three participants per centre will be included to test the procedures and assessments, excluding randomisation and intervention delivery. The study then progresses to the full pilot phase to evaluate and confirm the feasibility of the proposed trial. This pilot study will take place at the same two centres. The pilot study aligns with the design of the envisioned full trial, i.e. a pragmatic, multicentre, individually randomised superiority trial. A 1 to 1 allocation ratio will be used for the pilot. A total of 24 participants from the two centres will be recruited to investigate the pilot study objectives. The pilot endpoints will be used to determine the feasibility of recruitment and study procedures including data collection, assessments and delivery of the intervention (a 6-week program consisting of exercise sessions 3 times per week, 45&#xa0;min each). The results from the pilot study will be discussed within the pilot study steering group. Progression criteria will be reviewed to determine if the study progresses to a full trial, and which adaptations are needed.</p> Discussion <p>In case of a successful pilot, the study will progress to a full trial. The ambition of the full trial is to recruit 333 participants across 8 centres in Belgium, and to investigate the effectiveness of home rehabilitation for older persons discharged from the hospital with disability.</p> Trial registration <p>Clinicaltrials.gov, <a href="https://clinicaltrials.gov/study/NCT06404138">NCT06404138</a> on 08 May 2024.</p>

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Recovery from disability after geriatric-home rehabilitation versus standard of care: protocol for a pilot study in older persons with disability at hospital discharge

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月21日

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  • Bastiaan Van Grootven,
  • Margreet van Dijk,
  • Farah Islam,
  • Birgit Coucke,
  • Steffen Fieuws,
  • Gijs Van Pottelbergh,
  • Johan Flamaing,
  • Nele Van Den Noortgate,
  • Anja Velghe,
  • Anne-Marie De Cock,
  • Sophie Gillain,
  • Joris Meeuwissen,
  • Ivan Bautmans,
  • David Beckwée,
  • Marie de Saint-Hubert,
  • Jannique van Uffelen,
  • Didier Schoevaerdts,
  • Jos Tournoy,
  • Theo van Achterberg

摘要

Background

Currently, there is insufficient evidence supporting geriatric home rehabilitation after hospital discharge. Some studies demonstrate a positive effect, but meta-analytic evidence demonstrates uncertainty on the magnitude of the expected effect. Yet, evidence from other populations indicates that home rehabilitation could also be an effective strategy for older persons. Therefore, we aim to evaluate the effectiveness of geriatric home rehabilitation in older persons discharged from the hospital with disability. Given the potential challenges in recruiting participants delivering the intervention, and executing other study procedures in a multi-centre study, we will first carry out a pilot study.

Methods

The pilot study will commence with an initial start-up phase at two centres: UZ Leuven and CHU UCL Namur, Belgium. Up to three participants per centre will be included to test the procedures and assessments, excluding randomisation and intervention delivery. The study then progresses to the full pilot phase to evaluate and confirm the feasibility of the proposed trial. This pilot study will take place at the same two centres. The pilot study aligns with the design of the envisioned full trial, i.e. a pragmatic, multicentre, individually randomised superiority trial. A 1 to 1 allocation ratio will be used for the pilot. A total of 24 participants from the two centres will be recruited to investigate the pilot study objectives. The pilot endpoints will be used to determine the feasibility of recruitment and study procedures including data collection, assessments and delivery of the intervention (a 6-week program consisting of exercise sessions 3 times per week, 45 min each). The results from the pilot study will be discussed within the pilot study steering group. Progression criteria will be reviewed to determine if the study progresses to a full trial, and which adaptations are needed.

Discussion

In case of a successful pilot, the study will progress to a full trial. The ambition of the full trial is to recruit 333 participants across 8 centres in Belgium, and to investigate the effectiveness of home rehabilitation for older persons discharged from the hospital with disability.

Trial registration

Clinicaltrials.gov, NCT06404138 on 08 May 2024.