Ntelligently Integrated Digital Rehabilitation Model Combining mHealth and ERAS in Total Hip and Knee Arthroplasty
NCT ID: NCT07199478
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
140 participants
INTERVENTIONAL
2025-09-01
2025-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Intervention Group
Participants received the standardized Enhanced Recovery After Surgery (ERAS) protocol plus the digital intervention via the "Joint Recovery Assistant" WeChat mini-program.
Integrated mHealth and ERAS Digital Rehabilitation via WeChat Mini-Program
This intervention arm is distinguished by the following key features:
Theory-Driven Design: Uniquely integrates three established behavioral theories into its core functionality: Bandura's Self-Efficacy Theory, the Health Belief Model, and Illeris's Learning Model. This theoretical foundation directly informs the app's features to target psychological and behavioral barriers to recovery.
Multi-Functional Platform: Combines several evidence-based components into a single, cohesive platform within the ubiquitous WeChat ecosystem. Key features include:
Visual Goal and Progress Tracking: Provides patients with "mastery experiences."
Peer Community ("Modeling Community"): Features patient stories and videos to provide "vicarious experiences" and social support.
AI-Powered Persuasion System: Delivers automated, personalized feedback and remote encouragement from healthcare providers.
Built-in Emotional Management Tools: Includes an emotion diary
Control group：Standardized ERAS Protocol
Standardized ERAS Protocol
Standardized ERAS Protocol
Participants received only the standardized Enhanced Recovery After Surgery (ERAS) protocol, representing the conventional care model.
Interventions
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Integrated mHealth and ERAS Digital Rehabilitation via WeChat Mini-Program
This intervention arm is distinguished by the following key features:
Theory-Driven Design: Uniquely integrates three established behavioral theories into its core functionality: Bandura's Self-Efficacy Theory, the Health Belief Model, and Illeris's Learning Model. This theoretical foundation directly informs the app's features to target psychological and behavioral barriers to recovery.
Multi-Functional Platform: Combines several evidence-based components into a single, cohesive platform within the ubiquitous WeChat ecosystem. Key features include:
Visual Goal and Progress Tracking: Provides patients with "mastery experiences."
Peer Community ("Modeling Community"): Features patient stories and videos to provide "vicarious experiences" and social support.
AI-Powered Persuasion System: Delivers automated, personalized feedback and remote encouragement from healthcare providers.
Built-in Emotional Management Tools: Includes an emotion diary
Standardized ERAS Protocol
Participants received only the standardized Enhanced Recovery After Surgery (ERAS) protocol, representing the conventional care model.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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).
18 Years
80 Years
ALL
No
Sponsors
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The Affiliated Hospital Of Southwest Medical University
OTHER
Responsible Party
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XiaoYue Li
The Affiliated Hospital Of Southwest Medical University
Locations
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The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China
Countries
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Other Identifiers
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SH9H-2024-001
Identifier Type: -
Identifier Source: org_study_id
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