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临床试验/NCT07201116
NCT07201116已完成不适用

Effectiveness of a Geographic Information System-Integrated Mobile Platform for Coordinating Early Stage Rehabilitation After Total Hip Arthroplasty: A Randomized Controlled Trial

Tulip Medicine2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
2
主要终点
Time to Rehabilitation Initiation

研究概览

简要总结

This study tests whether a mobile phone app with mapping technology can help patients find rehabilitation services faster after hip replacement surgery. After having their hip replaced, patients typically need several months of physical therapy to recover fully. However, many patients face long waiting times or don't know where to find rehabilitation services near them.

In this study, half of the patients will use a new mobile app that shows rehabilitation centers on a map, displays available appointment times, and allows patients to compare services and costs. The other half will receive standard care, where they must contact their family doctor to help find rehabilitation services.

The study will measure how quickly patients start rehabilitation after leaving the hospital, how well their hip functions after treatment, their quality of life, and pain levels. The investigators will also look at whether the app is easy to use.

详细描述

Total hip arthroplasty (hip replacement) is one of the most successful surgical procedures in modern orthopedics, with over 528 million people worldwide affected by osteoarthritis requiring joint replacement. The demand is projected to increase dramatically: 71% growth in the US by 2030 (635,000 procedures), 198% growth in Australia by 2046 (94,086 procedures), and 99-147% growth in Japan by 2030 depending on demographic groups.

Success of hip replacement surgery largely depends on timely access to rehabilitation services, particularly during the early recovery period (first 3-6 months post-surgery). Current medical rehabilitation principles emphasize early initiation, continuity, and seamless care coordination to optimize clinical outcomes. However, healthcare systems worldwide face significant challenges in organizing effective rehabilitation services.

The primary objective is to evaluate the effectiveness of implementing a GIS-integrated rehabilitation coordination platform for organizing early-stage rehabilitation after total hip arthroplasty. The investigators hypothesize that using a specialized mobile application with integrated GIS components will eliminate information gaps, ensure equitable patient flow distribution among medical organizations, reduce time from surgical discharge to second-stage rehabilitation initiation, and consequently improve functional treatment outcomes while enhancing healthcare system resource utilization efficiency.

After discharge from surgical hospitals, patients often encounter an information vacuum regarding available rehabilitation services. Primary care physicians typically have limited knowledge of regional rehabilitation centers, severely restricting patient routing options. This leads to systematic violations of key rehabilitation principles - early initiation and continuity of care - negatively impacting surgical outcomes.

Kazakhstan's healthcare system exemplifies these challenges, with critical imbalances between rehabilitation service demand and supply. Leading national centers performing thousands of hip replacements annually can provide rehabilitation to only a small fraction of patients, creating waiting lists extending several months. This disproportion generates systematic risks and healthcare delivery violations, with over 5.9 million healthcare delivery defects identified in 2024, including inappropriate service volume increases, unjustified medical care provision, and deviations from clinical protocols.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Completed primary total hip arthroplasty within the past 7 days
  • Ability to understand study procedures and provide signed informed consent
  • Fluency in Russian or Kazakh language
  • Access to smartphone or tablet device with internet connectivity

排除标准

  • Severe cognitive impairment
  • Participation in another clinical trial that might interfere with study outcomes
  • Intraoperative or postoperative complications requiring extended hospitalization after total hip arthroplasty
  • Medical contraindications to rehabilitation
  • Planned total hip arthroplasty within 12 months
  • Severe visual impairments preventing mobile application usage
  • Patients who declined to participate after being informed about the study protocol

研究组 & 干预措施

GIS-Guided Rehabilitation App

Experimental

Patients receive access to a specialized mobile application with integrated Geographic Information System (GIS) components for rehabilitation service coordination after total hip arthroplasty.

干预措施: Health-GIS Rehabilitation Coordination Platform (Device)

Standard Primary Care Referral

Active Comparator

Patients receive standard rehabilitation referral process through primary care physicians after total hip arthroplasty

干预措施: Standard Rehabilitation Referral (Other)

结局指标

主要结局

Time to Rehabilitation Initiation

时间窗: 12 months from enrollment

Time from discharge from surgical hospital to initiation of second-stage rehabilitation services, measured in days

SF-12 Quality of Life Score

时间窗: Baseline, 6 months, and 12 months from enrollment

12-Item Short Form Health Survey (SF-12) Physical Component Summary (PCS): 0-100 Mental Component Summary (MCS): 0-100 Higher scores indicate better quality of life and better health status.

次要结局

  • Harris Hip Score(Baseline, 6 weeks, 6 months, and 12 months from enrollment)
  • Visual Analog Scale (VAS) Pain Score(Baseline, 6 weeks, 6 months, and 12 months from enrollment)
  • System Usability Scale (SUS) Score(3 months and 6 months from enrollment)
  • Quality-Adjusted Life Years (QALY)(12 months from enrollment)

研究者

发起方
Tulip Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Didar Khassenov

Head of department

Tulip Medicine

研究点 (2)

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