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
{"title":"老年家庭康复后的残疾恢复与标准护理：一项针对出院时残疾老年人的试点研究方案。","authors":"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","doi":"10.1186/s40814-025-01668-8","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT06404138 on 08 May 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"87"},"PeriodicalIF":1.6000,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181865/pdf/","citationCount":"0","resultStr":"{\"title\":\"Recovery from disability after geriatric-home rehabilitation versus standard of care: protocol for a pilot study in older persons with disability at hospital discharge.\",\"authors\":\"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\",\"doi\":\"10.1186/s40814-025-01668-8\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>In case of a successful pilot, the study will progress to a full trial. 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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.
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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