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The COACH Project: Combined Online Assistance for Caregiver Health (COACH)

2018年1月16日 更新者:J. Kaci Fairchild, PhD、Palo Alto Veterans Institute for Research

Combined Online Assistance for Caregiver Health (COACH): The Efficacy of a Combined Physical Activity and Coping Skills Training Intervention for Caregivers

This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.

研究概览

研究类型

介入性

注册 (预期的)

200

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。

学习联系方式

  • 姓名:Jennifer Fairchild, PhD
  • 电话号码:63432 650-493-5000

研究联系人备份

  • 姓名:Marisol Hernandez
  • 电话号码:65992 650-493-5000

学习地点

    • California
      • Palo Alto、California、美国、94304
        • 招聘中
        • VA Palo Alto Health Care System
        • 接触:
          • Amerah Hashmi
          • 电话号码:65992 650-493-5000
        • 首席研究员:
          • Jennifer K Fairchild, PhD

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

18年 至 85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

描述

Inclusion Criteria:

  1. individuals aged 18 - 85
  2. distress associated with being the primary caregiver of a person with TBI or dementia
  3. endorsement of at least two of the following items: felt overwhelmed, felt like needed to cry, angry or frustrated, distant or cut of from family or friends, moderate to high levels of stress, felt their health had declined
  4. provide at least one hour of care (supervision or direct assistance) per week over the past three months
  5. approval by Primary Care Provider to participate in physical exercise
  6. be proficient in spoken and written English

Exclusion Criteria:

  1. current or lifetime history of any psychiatric disorder with psychotic features
  2. prominent suicidal or homicidal ideation
  3. current alcohol or substance abuse
  4. diagnosis of probable or possible dementia
  5. a Short Portable Mental Status score of ≥ 8
  6. participation in another caregiver intervention within the past year
  7. lack of regular access to the internet
  8. planned transfer of care recipient to another caregiver or nursing home within 12 months; 8) current severe cardiac disease (e.g., uncontrolled atrial fibrillation, defined as mean 24 hour heart rate >85 beats/min, or 24 hour maximal ventricular rate >150 beats/min; uncontrolled ventricular arrhythmias, defined as recurrent ventricular tachycardia >3 beats in succession, or 24 hour PVC count >20%; active pericarditis or myocarditis; Class III/IV heart failure and / or ejection fraction < 20%; thrombophlebitis; pulmonary disease with a drop in O2 Sat with exercise to 90% without oxygen; embolism within past 6 months)
  9. inability to participate in an exercise stress test
  10. morbid obesity (BMI > 39)
  11. inability to read, verbalize understanding and voluntarily sign the Informed Consent.

Caregivers meeting any of these exclusion criteria will be excluded from all aspects of this project.

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Combined Aerobic and Resistance Exercise
Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry. Exercises will focus on increasing the heart rate to a point at which participants will breathe more heavily and may sweat.
The combined moderate to high intensity combined aerobic and resistance exercise training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.
有源比较器:Balance and Flexibility
Participants will work with study staff to develop an individualized physical training program based on their level of functioning at study entry.
The stretching, balance and flexibility training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.

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
Caregiver Burden using Zarit Burden Inventory
大体时间:Six Months
Zarit Burden Inventory
Six 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。

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

2015年8月1日

初级完成 (预期的)

2018年7月1日

研究完成 (预期的)

2018年7月1日

研究注册日期

首次提交

2017年4月3日

首先提交符合 QC 标准的

2017年4月20日

首次发布 (实际的)

2017年4月21日

研究记录更新

最后更新发布 (实际的)

2018年1月18日

上次提交的符合 QC 标准的更新

2018年1月16日

最后验证

2018年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

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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