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Mobile Device to Help FRAX® Screening

2014年4月22日 更新者:National Taiwan University Hospital

The Effectiveness of Using Mobile Device and the World Health Organization Fracture Risk Assessment Tool (FRAX®) to Assist Osteoporosis Assessment and Management

Background: The Taiwanese FRAX® (Fracture Risk Assessment Tool) calculator is available online for clinical use. Our Taiwanese Osteoporosis Clinical Treatment Guidelines suggests using the American high risk cut-points for considering treatment but also suggests deriving domestic cut-points from cost-effective approach. Establishing cost-effective domestic cut-points for policy suggestions coupled with mobile devices with wireless access would potentially increase the usage of FRAX® tool.

Objectives: 1) Using literature review to establish cost-effectiveness FRAX® cut-points. 2) To assess the effectiveness of mobile devices assisted FRAX® tool based osteoporosis diagnostic and management model. 3) To provide FRAX® based reimbursement policy suggestions.

Methods: 1) Investigators will use FRAX®, cost-effectiveness and other key words to search Pubmed and international osteoporosis guidelines to better understand the clinical applications of FRAX® in other countries. Investigators will also search epidemiological data for osteoporosis, facture, quality of life and cost to establish domestic cost-effeteness, and translational approach FRAX® cut-points. 2) Three targeting populations from National Taiwan University Hospital (NTUH) are selected for prospective study (Group A: geriatric health exam clinics with American cut-points, group B: orthopedic clinics with translational approach cut-points and group C: endocrine clinics with cost-effectiveness cut-points,). A mobile device with app application coupled with the FRAX® tool is used by a trained research assistant during clinic waiting periods to screen and enroll high risk (75 from each clinic) adults with informed consents. Participants are referred to geriatric clinics for systemic osteoporosis diagnoses and managements. Percentage of participants that meet the current NHI medication reimbursement regulation and percentage of self-pay medications are calculated. Analysis is stratified by age and gender. 3) The impacts of 3 different cut-points on increment NHI reimbursement are estimated. An osteoporosis expert group meeting is to be held for FRAX® based osteoporosis medication reimbursement modifications to the NHI and the Department of Health.

Expected Outcomes: 1) To establish the mobile device assisted FRAX® based osteoporosis screening and management model. 2) Base on the study results and expert consensus, investigators will provide policy suggestions of FRAX® based reimbursement modifications.

研究概览

地位

完全的

详细说明

This is an observational study. The study outcomes might base on clinical physician opnions to provide policy suggestion of FRAX® at which cut-point is considering for treatment.

研究类型

观察性的

注册 (实际的)

225

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾、100
        • National Taiwan University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 90年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults visitng geraitric health exam clinics, orthopedic clinic, and endocrinology clinic

描述

Inclusion Criteria:

  • age 40-90
  • screen high risk from FRAX

Exclusion Criteria:

  • treated with anti-osteoporosis medications within last 3-12 months (depends on medication types)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Group A, B, C
Group A- American cut-point Group B- Translational approach cut-point Group C- Cost-effectiveness cut-point

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Number of enrollment cases
大体时间:in 6 month
target 75 in each group, total 225
in 6 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ding-Cheng Chan, MD, PhD、National Taiwan University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年3月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2013年7月3日

首先提交符合 QC 标准的

2013年8月28日

首次发布 (估计)

2013年8月29日

研究记录更新

最后更新发布 (估计)

2014年4月23日

上次提交的符合 QC 标准的更新

2014年4月22日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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