Application of an Intelligently Integrated Digital Rehabilitation Model Combining mHealth and ERAS in Total Hip and Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change from Baseline in Physical Function at 6 weeks post-surgery, measured by the Hip disability and Osteoarthritis Outcome Score-Physical Function Shortform (HOOS-PS) or Knee injury and Osteoarthritis Outcome Score-Physical Function Shortform (KOOS-PS)
研究概览
简要总结
Protocol
This study is a single-center, randomized controlled trial designed to evaluate the effectiveness of a WeChat-based mini-program mobile health (mHealth) intervention combined with an Enhanced Recovery After Surgery (ERAS) protocol for postoperative rehabilitation in patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). The study will be conducted at the Affiliated Hospital of Southwest Medical University from July 2025 to December 2025, approved by the Ethics Committee (SH9H-2025-021), and registered on a clinical trials platform.
The study population consists of adults scheduled for unilateral primary THA or TKA, aged 18-80 years, with basic smartphone proficiency. Exclusion criteria include revision surgery, bilateral surgery, severe cognitive impairment, or baseline depression. Using a block randomization method stratified by surgical site (hip vs. knee), eligible participants will be allocated in a 1:1 ratio to either the intervention group (ERAS + "Joint Rehabilitation Assistant" mini-program) or the control group (ERAS only). The control group receives standard ERAS management, while the intervention group additionally uses the theoretically-grounded mini-program (based on self-efficacy theory, health belief model, and learning theory), which provides personalized rehabilitation plans, progress tracking, community interaction, and emotional support.
The primary outcome is physical function (HOOS-PS/KOOS-PS) at 6 weeks postoperatively. Secondary outcomes include pain, psychological status, quality of life, and safety indicators. The calculated sample size is 70 patients per group (total 140), accounting for a 20% dropout rate. Statistical analysis will follow the intention-to-treat principle, using linear mixed models to compare intergroup differences, with subgroup and sensitivity analyses performed. All outcome assessments will be conducted by blinded personnel to ensure data quality.
This protocol aims to validate the effectiveness and safety of the integrated digital rehabilitation model in improving functional recovery and quality of life, providing evidence-based support for post-arthroplasty rehabilitation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years old. Surgery Type: Scheduled to undergo unilateral primary total hip arthroplasty (THA) or total knee arthroplasty (TKA).
- •Physical Status: American Society of Anesthesiologists (ASA) classification I-III.
- •Digital Literacy: Confirmed ability to use a smartphone via a standardized digital literacy test.
- •Compliance: Willing and able to adhere to the study protocol.
排除标准
- •Surgery Type: Revision surgery or simultaneous bilateral surgery. Cognitive Function: Presence of severe cognitive impairment (Mini-Mental State Examination (MMSE) score <24).
- •Arthritis Type: Inflammatory arthritis (e.g., rheumatoid arthritis). Psychological Status: Presence of depressive state at baseline (Hospital Anxiety and Depression Scale (HADS) depression subscale score ≥15).
研究组 & 干预措施
Intervention Group
Participants received the standardized Enhanced Recovery After Surgery (ERAS) protocol plus the digital intervention via the "Joint Recovery Assistant" WeChat mini-program.
干预措施: Integrated mHealth and ERAS Digital Rehabilitation via WeChat Mini-Program (Procedure)
Control group：Standardized ERAS Protocol
Standardized ERAS Protocol
干预措施: Standardized ERAS Protocol (Procedure)
结局指标
主要结局
Change from Baseline in Physical Function at 6 weeks post-surgery, measured by the Hip disability and Osteoarthritis Outcome Score-Physical Function Shortform (HOOS-PS) or Knee injury and Osteoarthritis Outcome Score-Physical Function Shortform (KOOS-PS)
时间窗: 6 weeks post-surgery
Standardized Video Interview: The outcome was assessed by blinded evaluators using a standardized video interview protocol to ensure consistency and reduce assessment bias, unlike studies using unblinded in-person assessments or unstandardized patient self-report. Joint-Specific Patient-Reported Outcome Measures (PROMs): Uses validated, joint-specific short forms (HOOS-PS/KOOS-PS) that are optimized for measuring physical function in the target population, rather than generic functional scales. Early Post-Discharge Timepoint: The primary endpoint is set at 6 weeks, a key early post-discharge period where digital intervention support is hypothesized to have the greatest impact on functional recovery trajectories, as opposed to longer-term endpoints (e.g., 6 months or 1 year).
次要结局
- Pain Intensity(Baseline (preoperatively), 6 weeks, and 10 weeks postoperatively.)
- Psychological Status(Baseline (preoperatively), 6 weeks, and 10 weeks postoperatively.)
- Self-Efficacy(Timepoints: Baseline (preoperatively), 6 weeks, and 10 weeks postoperatively.)
- Safety Outcomes(Timepoints: Monitored continuously from randomization until the 10-week follow-up visit.)
研究者
XiaoYue Li
The Affiliated Hospital Of Southwest Medical University
The Affiliated Hospital Of Southwest Medical University