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临床试验/NCT03376711
NCT03376711Unknown不适用

Development & Pilot Randomized Control Trial (RCT) of an Online Peer Support Program for Family Caregivers of Ventilator-Assisted Individuals Living in the Community

University of Toronto2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Change in Positive and Negative Affect

研究概览

简要总结

Ventilator assisted individuals (VAIs) living at home are frail and generally cannot perform most daily activities. Although these individuals prefer to live at home, the family members who care for them often experience stress and poor health. Peer support can mitigate health declines by decreasing caregivers' isolation/stress and increasing their sense of control. However, no peer support programs are designed to meet these caregivers' complex and unique needs. Online support delivery is especially beneficial for caregivers given the geographic and time limitations they face. The proposed research aims to develop and conduct an RCT of online peer support program for VAI caregivers. A group of caregivers will be trained to act as peer mentors. This training program will be evaluated for its impact on caregivers' mentoring abilities. At the end of the 12-week program, caregiving participants will be asked about the online delivery of the program, how helpful/satisfactory it was, and if it affected their health and well-being. The health outcomes of the control and intervention group will be compared. This peer support program can improve the well-being of caregivers and allow them to better care for their family members.

研究设计

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

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; 2) primary family caregiver for a VAI living in the community; 3) able to speak and read English; and 4) access to a computer and a reliable internet connection.

排除标准

  • currently experiencing severe depression as indicated by a score of 40 or higher on the Centre for epidemiological studies short depression scale (CES-D 10).

研究组 & 干预措施

Standard Care Group

No Intervention

Participants in this arm of the study will not have access to the online peer support program until the end of the 12-week trial.

Online Peer Support Program

Experimental

Participants in the online peer support program arm of the intervention will have access to the website for 12 weeks.

干预措施: Online Peer Support Program (Behavioral)

结局指标

主要结局

Change in Positive and Negative Affect

时间窗: Change from baseline at 12 weeks

Positive \& Negative Affect Scale (PANAS): 10 items \[Score: 10-50\]; higher scores indicate more psychological wellbeing

次要结局

  • Feasibility: Participation rate(12 weeks)
  • Feasibility: Participation frequency(12 weeks)
  • Feasibility: Recruitment rates(Through study completion, an average of 1 year)
  • Feasibility: Attrition(12 weeks)
  • Change in Coping(Change from baseline at 12 weeks)
  • Change in Depression(Change from baseline at 12 weeks)
  • Change in Caregiving Impact(Change from baseline at 12 weeks)
  • Change in Mastery(Change from baseline at 12 weeks)
  • Change in Personal Gain(Change from baseline at 12 weeks)

研究者

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

Louise Rose

Associate Professor

University of Toronto

研究点 (2)

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