RITH4Hips - Rehabilitation in the Home After Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- De Morton Mobility Index (DEMMI)
研究概览
简要总结
Hip fractures are common, especially in older adults, and they can have a big impact on health and quality of life. In Australia, hip fractures are a significant healthcare challenge. After surgery, patients often need rehabilitation to regain mobility, but this usually involves long hospital stays. The RITH4Hips trial will determine if a program where patients receive rehabilitation at home (instead of in the hospital) is similar to conventional inpatient rehabilitation.
Objectives:
The main goal of this study is to find out if rehabilitation at home after surgery for a hip fracture works as well as rehabilitation in the hospital. The investigators also want to see if the home rehabilitation program can reduce the time spent in a hospital bed and improve other aspects like quality of life, mobility, and pain management.
Methods:
This study will involve older adults who have had surgery due to a low-trauma hip fracture. Participants will be randomly assigned to either the usual care inpatient rehabilitation or the Rehabilitation in the Home (RITH) program. The investigators will measure outcomes such as how well patients can move, how much pain they experience, how their quality of life improves, and how much time they spend in the hospital.
Expected Outcomes:
The investigators expect that the home rehabilitation program will be just similar to inpatient rehabilitation in helping patients recover mobility. The investigators also hope to find that it will reduce the time patients spend in a hospital bed, improve their quality of life, reduce fear of falling, and lessen the burden on carers. Additionally, the investigators aim to show that the home program is more cost-effective than hospital-based rehabilitation.
详细描述
Study Aim This study aims to determine whether a multidisciplinary Rehabilitation in the Home (RITH) program for patients following low-trauma hip fracture (LTHF) is non-inferior to inpatient rehabilitation in terms of mobility during activities of daily living (ADL), assessed using the de Morton Mobility Index (DEMMI)
Study Design This is a pragmatic, multicentre, randomised, single-blinded, parallel-group, non-inferiority clinical trial with an embedded qualitative component.
As part of recruitment monitoring, reasons for declining participation will be recorded for individuals approached but not enrolled.
Hypotheses
The investigators hypothesise that compared to inpatient rehabilitation, the RITH program will be:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor and statistician will be blinded to randomisation outcomes and will perform assessments on all participants from both arms. Assessments will be conducted at two time points: at the completion of the program (UCIR or RITH) and at six weeks following initial hospital admission. This blinding minimises potential bias in outcome evaluation and ensures the integrity, reliability, and objectivity of the trial's findings.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Community-dwelling adults ages ≥ 50 years presenting to Liverpool hospital or Bankstown-Lidcombe hospital with a low-trauma (osteoporotic) hip fracture who undergo surgical management
- •Anticipated to return to community (private) residence
- •Permitted to weight-bear as tolerated post-surgery
- •Suitable for inpatient rehabilitation (i.e., requires multidisciplinary rehabilitation, is considered cognitively suitable by the MDT to participate in the rehabilitation program being examined, and would otherwise be admitted to inpatient rehabilitation)
- •The presence of a carer, if required for mobility or function, is necessary at the time of transfer to the community. The carer must be prepared to manage the patient within 3 days post-randomisation. This time frame is considered necessary as carers will not be able to complete all required preparations before randomisation, and allowing an extended preparation period could bias the length of physical ward bed stay for the RITH group
- •Suitable environment for home-based rehabilitation as assessed by the MDT as per usual practice
排除标准
- •Presence of a concomitant condition that precludes actively participating in a rehabilitation program at home
- •Residential location outside the Bankstown-Canterbury, Liverpool, and Fairfield Local Government Areas
- •Active end-of-life management or palliative care
- •Previously participated in the HITH4Hips or RITH4Hips trials
研究组 & 干预措施
Rehabilitation in the Home (RITH)
Participants randomised to the experimental pathway. Participants will receive home-based therapy from a multidisciplinary (MDT) team, including physiotherapists, occupational therapists, social workers, dieticians, medical practitioners, psychologists, and pharmacists.
干预措施: Rehabilitation in the home (Other)
Usual Care Inpatient Rehabilitation (UCIR)
Participants randomised to the usual care pathway. Participants will receive care in a rehabilitation ward or subacute hospital, including therapy from a multidisciplinary team.
干预措施: Usual care inpatient rehabilitation (Other)
结局指标
主要结局
De Morton Mobility Index (DEMMI)
时间窗: At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.
The De Morton Mobility Index is a mobility outcome measure specifically designed for an older population. The DEMMI assesses 15 tasks which are associated with activities of daily living such as bed mobility and sit-to-stand transitions. The DEMMI is scored between 0 - 100, where 0 represents no mobility and 100 represents full mobility. The Minimal Clinically Important Difference (MCID) for the DEMMI is estimated to be approximately 6 points, representing the smallest change necessary to reflect a clinically meaningful improvement in mobility.
次要结局
- Length of Stay (LOS) - Physical Ward Bed(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).)
- Length of Stay (LOS) - Total(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).)
- Index Hip Pain(Assessments will occur at baseline (within 24 hours prior to randomisation), daily during the allocated rehabilitation program (an average of 14 days from admission to rehabilitation), and at 6 weeks following initial hospital admission.)
- Positive Aspects of Caregiving Scale (PACS)(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).)
- EuroQol-5D-5L (EQ5D)(Assessments will be conducted at baseline (within 24 hours prior to randomisation), at 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation), and at 6 weeks post-admission.)
- Timed Up-and-Go Test (TUG Test)(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.)
- Falls Efficacy Scale (FES)(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.)
- Hospital-Acquired Complications (HACs)(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).)
- Zarit Carer Burden Interview (ZCBI)(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation).)
- Functional Independence Measure (FIM)(At 1 to 3 days following discharge from the rehabilitation program (an average of 14 days after admission to rehabilitation) and at 6 weeks after initial admission.)
研究者
Thuy Anh Bui
Principal Investigator
South West Sydney Local Health District