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Back to the Future: Bridging the Hospital to Home Continuum After Hip Fracture (B2F)

2017年10月25日 更新者:Dolores Langford、University of British Columbia

A Feasibility Study Investigating Telephone Supported Discharge From Acute Care to the Community After Hip Fracture

The purpose of this study is to determine whether is is feasible and acceptable to deliver a telephone based coaching intervention compared with education alone in community dwelling older adults (age 60 and older) after a fall related hip fracture.

研究概览

详细说明

The investigators propose a randomized controlled trial design to inform the development of a larger scale study to test effectiveness of a clinician supported telephonic self management intervention for older adults after hip fracture. The primary aim is to determine feasibility and acceptability of the intervention, and the secondary aim is to measure statistical trends on quality of life at 4 months after fracture in community dwelling older adults. In parallel, we will conduct a process evaluation to ascertain key features of the intervention via qualitative interviews of participants and health care professionals involved in delivery of the intervention.

研究类型

介入性

注册 (预期的)

30

阶段

  • 不适用

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

    • British Columbia
      • North Vancouver、British Columbia、加拿大、V7L 2L7
        • Lions Gate 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

60年 至 100年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adults (men and women) over 60 years of age
  • Fall related hip fracture
  • Community dwelling
  • English speaking

Exclusion Criteria:

  • Dementia
  • Medical co-morbidities precluding physical activity (significant heart failure, palliative conditions etc.)
  • Profound hearing loss

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

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Education Only
  • A 1 hour education session in the acute setting
  • A toolkit with education, exercise and self management instructions for after hip fracture
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
实验性的:Education + Telephone Follow-up
  • A 1 hour education session in the acute setting
  • A telephone delivered self management program , including a toolkit (education, exercise and self management instructions for after hip fracture), support to take an active role in recovery, including setting and monitoring goals, problem solving mobility barriers, and guidance on the recovery process following a hip fracture.
An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture

The participants will receive up to 5 telephone calls of 30-45 minutes each after hospital discharge to provide support and education for the transition from acute to community care. The first call will be made within 48-72 hours of hospital discharge and will have the following elements:

  • Health Status
  • Medication Management
  • Activity/Exercise Prescription and Goal-Setting
  • Falls Prevention
  • Clarification of Appointments
  • Coordination of Post-Discharge Home Services
  • What To Do If a Problem Arises

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
Feasibility of study recruitment and retention
大体时间:1 year
Feasibility will be measured by recruitment rate (30%), and retention rate (<10% attrition)
1 year

次要结果测量

结果测量
措施说明
大体时间
Quality of Life EQ5D-5L
大体时间:4 months
The EQ5D-5L Quality of Life outcome measure is a self reported questionnaire measure, and has been extensively investigated in the hip fracture population, with well established sensitivity, reliability and validity properties.
4 months

其他结果措施

结果测量
措施说明
大体时间
Quality of Life ICECAP-O
大体时间:4 months
4 months
de Morton Mobility Index (DEMMI)
大体时间:4 months
The DEMMI is a clinical instrument for measuring mobility in older adults. Interval levels are obtained from 0 (poor mobility) to 100 (excellent mobility)
4 months
Gait (Walking) speed
大体时间:4 months
Gait speed is a reliable, valid and sensitive measure likened to a vital sign.
4 months
Falls FES-1
大体时间:4 months
Falls self efficacy questionnaire will be used.
4 months
Pain: Visual Analogue Scale (VAS)
大体时间:4 months
4 months
Falls self report diary
大体时间:4 months
Participants will record Falls in a check box format daily
4 months
The Hospital Anxiety and Depression Scale (HADS)
大体时间:4 months
The HADS is a 14 item self reported questionnaire designed to assess anxiety and depression
4 months

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:Dolores P Langford, Msc.、Vancouver Coastal Health
  • 研究主任:Maureen C Ashe, PhD、Centre for Hip Health and Mobility

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11月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2013年7月31日

首先提交符合 QC 标准的

2013年8月23日

首次发布 (估计)

2013年8月28日

研究记录更新

最后更新发布 (实际的)

2017年10月27日

上次提交的符合 QC 标准的更新

2017年10月25日

最后验证

2017年10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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