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临床试验/NCT04287101
NCT04287101已完成不适用

Home-Based Integrated Post-Acute Care Program for Hip Fracture

Taipei City Hospital1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Pain intensity Using the numerical pain rating scale (NPRS)

研究概览

简要总结

Background and purpose: Hip fracture, a common injury occurred in people aged over 50, may result in disability, poor quality of life, and higher care stress for their families. Aging population and growing number of hip fractures have increased medical expenses, so developed countries implemented post-acute care (PAC) to reduce acute hospitalization, and to improve the quality of care. PAC services can be delivered by hospital/facility-based and home-based services. Previous studies showed that both services could significantly improve patients' activities of daily living and quality of life, and reduce readmissions, long-term care and costs. Taiwan has implemented PAC plan for hip fractures since 2017, but relevant evidences are limited. Therefore, the purpose of this study is to analyze the efficacy and cost-effectiveness of PAC for patients with hip fractures.

详细描述

Methods: This is a prospective cohort study which will recruit patients aged over 50 with hip fractures receiving surgical treatment in the Taipei City Hospital. They will be provided home-based PAC, hospital-based PAC, or no formal PAC based on the medical judgment and patients/families' willingness. The period of PAC will be two to three weeks after the acute hospitalization. Assessments include physical function (30 seconds sit to stand, Barthel index, and Harris Hip Score), numerical pain rating scale, EuroQol instrument (EQ-5D), Caregiver Strain Index, and using of medical resources. The assessments will be on the day before discharge from acute hospitalization, and on the discharge day from post-acute care. The follow-up assessment will be at 1, 3, 6, and 12 months after operation. The cost-effectiveness ratio will be defined as the New Taiwan dollars paid for 1-unit improvement of functional performance and quality of life.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • First hip fracture
  • Stable medical condition

排除标准

  • Hip fracture caused by major trauma or pathological condition
  • Multiple fractures
  • Severe physical disability before the hip fracture
  • Unable to cooperate with treatment
  • Further inpatient treatment

结局指标

主要结局

Pain intensity Using the numerical pain rating scale (NPRS)

时间窗: within 1 year

Using the numerical pain rating scale (NPRS) to measure participants' pain intensity. Ask participants to report their pain intensity with the 11-point scale (from 0 no pain to 10 worst possible pain).

Activities of daily living Using the Barthel Index (BI)

时间窗: within 1 year

Using the Barthel Index (BI) to measure participants' activities of daily living. The self-care domain is self-report by the patient or their families. The mobility domain is observed by the assessor. The greater score indicates more independence.

Functional performance of hip Using the Harris hip score (HHS)

时间窗: within 1 year

Using the Harris hip score (HHS) to measure participants' functional performance of hip. The pain domain is self-report by the patient. The function, deformity, and range of motion domain are observed by the assessor. The greater score indicates the better functional performance of hip.

Caregiver strain Using the caregiver strain index (CSI)

时间窗: within 1 year

Using the caregiver strain index (CSI) to measure the strain of caregiver. Ask them to fill a 13-item questionnaire. Greater value indicates a higher strain.

30-second sit to stand

时间窗: within 1 year

Ask participants to cross their arms at the chest, and to perform sit to stand as more as possible within 30 seconds. Measure the repetitions the participants do. Higher repetition indicates more strength of lower extremities.

Medical Costs

时间窗: within 1 year

Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.

Quality of lives Using the EuroQol instrument (EQ-5D)

时间窗: within 1 year

Part 1: Ask participants to measure their mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the 3-point scale. The greater score indicates poor quality of life.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Shih-Liang Shih

Director of Orthopedics

Taipei City Hospital

研究点 (1)

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