Stronger at Home: Improve Functional Outcomes for Community-dwelling Older Adults After Hip Fracture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The Lower Extremity Functional Scale (LEFS)
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness of a new 14-week individually-tailored home-based rehabilitation program called "Stronger at Home" with usual care in improving functional recovery in community-dwelling older adults after hip fractures.
The main question this trial aims to answer are:
• Is the Stronger at Home program more effective than usual care in improving functional recovery at the end of the 14-week intervention?
secondary questions include:
- What is the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge?
- Does the program have a sustained impact on functional recovery at 6 months and 12 months post-discharge?
Participants in the trial will be asked to engage in the following tasks:
- Participate in the Stronger at Home program, which includes using a self-directed toolkit consisting of educational resources and an illustrated exercise program.
- Follow the guidelines provided in the toolkit for gradually increasing exercise intensity and incorporating different types of exercises into their daily life.
The effects of the Stronger at Home program will be compared to those of usual care.
详细描述
The primary research question of this project is whether the Stronger at Home program, a 14-week individually-tailored home-based rehabilitation program, is more effective than usual care in improving functional recovery in community-dwelling older adults after hip fractures. The evaluation of effectiveness will be conducted at the end of the intervention, which is the primary time point.
In addition to the main research question, secondary aims of the project include evaluating the cost-utility of the Stronger at Home program compared to usual care at 3.5 months, 6 months, and 12 months after discharge. The program's impact on functional recovery will also be assessed at medium-term (6 months) and long-term (12 months) follow-ups after the participants are discharged from the hospital to their homes.
The need for conducting this trial arises from a knowledge gap in effective rehabilitation programs for community-dwelling individuals with hip fractures. The Stronger at Home program was developed through a multistage study incorporating a self-directed toolkit and a new model of care. The development process involved critical analysis of previous programs, adherence to four principles of a successful program, and consultations with researchers, policymakers, older adults, and clinicians. The toolkit includes an educational component and an illustrated exercise program with progressively increasing intensity.
The pilot study of the Stronger at Home program has shown feasibility, with positive feedback from healthcare providers and patients regarding its value.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
盲法说明
In this type of trial, the researchers responsible for assessing the outcomes remain unaware of the treatment assignments. The purpose of single-blind masking is to minimize bias and ensure that the assessment of outcomes is not influenced by researchers' expectations or knowledge of the treatment.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Hip fracture patients who are 55 years or older,
- Currently living in the community, and
- Either being discharged to their home or a retirement home
- Fall from a standing height or less
- Live within 45km radius of recruitment site
排除标准
- Came from long term care or discharged to long term care
- Not a hip fracture (e.g., pelvic fracture)
- Unable to give consent and no proxy
- Fracture due to pathological disease (e.g., cancer, Paget's disease).
- Does not speak English and no translator
- Fracture sustained at hospital
- Terminal illness or exercise contraindications
- Discharged with other services not eligible
研究组 & 干预措施
Intervention (Stronger at Home model)
This study implements a 14-week home-based rehabilitation program for older adults after hip fractures. Participants will receive 8 home visits by a Physiotherapist (PT) and/or Physio assistant(PTA), focusing on individualized exercise programs and pain self-management. The intervention aims to improve functional recovery and includes PT-led assessments, exercise adjustments, and discharge assessments. PTAs support exercise delivery and education. The clinical team comprises PTs and PTAs, receiving training on exercise principles, pain education, and goal setting. The program emphasizes progressive strengthening, balance, and functional exercises, adhering to evidence-based principles. The intervention aims to enhance efficiency, reduce wait times, and promote adherence.
干预措施: The Intervention (Stronger at Home Intervention) (Other)
Control (usual care)
The control group will receive usual home care provided by the healthcare system, which could vary between cases. We'll document their received care during follow-ups as it is inconsistent and poorly recorded. Regular check-in calls by the study coordinator will remind them of assessments, reducing attrition.
干预措施: Usual care (Control) (Other)
结局指标
主要结局
The Lower Extremity Functional Scale (LEFS)
时间窗: 3.5 months (post intervention )
The primary outcome of the study (functional abilities) will be assessed using the Lower Extremity Functional Scale (LEFS), a patient-reported outcome measure consisting of 20 items. The LEFS has been validated for various populations, including patients recovering from hip surgeries, and has shown excellent reliability, validity, and responsiveness. It provides a score ranging from 0 to 80 based on the responses to each item's options. The LEFS was chosen based on its ability to evaluate important functional activities for patients, and its use as a primary outcome in the pilot study helped determine the sample size for this trial.
次要结局
- Pain measured with Numerical Analogue Scale (NAS)(Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.)
- Clinical Frailty Scale(Baseline and 3.5 months, 6 months, 12 months after discharge)
- Short Fear of Falling Scale(Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.)
- The Short Physical Performance Battery (SPPB)(Baseline, and at 3.5 months, 6 months, and 12 months after discharge.)
- Modified Falls Efficacy Scale(Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.)
- Tampa Scale of Kinesiophobia (TSK)(Baseline, and 3.5 months, 4.5 months, 6 months, 7.5 months, 9 months, 10.5 months, and 12 months after discharge.)
- Short Depression Scale(Baseline, and 4.5 months, 7.5 months, 9 months, and 10.5 months after discharge)
- 2-Minute Walk Test (2MWT)(Baseline, and at 3.5 months, 6 months, and 12 months after discharge.)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05972005
- 其他研究编号
- 6032153
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否