跳至主要内容
临床试验/NCT04588415
NCT04588415已完成不适用

Supporting Family Members With Severe Grief Reaction During the COVID-19 Pandemic

Ottawa Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2021年1月3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
121
试验地点
2
主要终点
The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death

研究概览

简要总结

This is a feasibility study taking place at The Ottawa Hospital (TOH), Hôpital Montfort, and Queensway Carleton Hospital that seeks to evaluate the impact of the COVID-19 pandemic on family member bereavement and study the effect of virtual support groups on reducing risk of developing Severe Grief Reaction (SGR). This project is inviting family members of deceased patients at either of the three before mentioned sites to enroll in this study.

详细描述

Background:

Severe grief reactions (SGR), or complicated grief (CG), are experienced by 2-3% of the population after the loss of a loved one, and can be associated with declining health, social distress, increased use of healthcare resources and higher mortality. SGR can be related to the circumstances of the patient at the end of life, particularly in deaths that were unexpected or traumatic, when the family member was unprepared or unsupported. The COVID-19 pandemic has affected many aspects of end-of-life care. For example, infection control measures may reduce interactions between long-term care residents and family members, and have often limited in-person family visiting to the final hours of life, or no visiting at all for patients with COVID-19. Anecdotally, this disruption of normal interactions has been difficult for patients and families alike, and it is known that isolation and lack of closure with a loved one can contribute to the risk of SGR. The prevalence of SGR is expected to rise amid increased challenges in supporting a surge of people with SGR due to physical distancing and limited bereavement resources.

Methods:

The proposed mixed methods explanatory study includes both retrospective and prospective data collection. The quantitative components will principally consist of natural experiments to identify patient/FM characteristics indicating a high risk of SGR during the COVID-19 pandemic. The qualitative components will deepen an understanding of the impact of COVID-19 on bereavement, while providing a formative evaluation for the virtual support groups. Study subjects will include all patients who died in an acute care facility in Ottawa (The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort) from January 1, 2020 until June 30, 2020, and their primary contact (as indicated in their medical record).

Significance:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • Family Members of deceased patients from The Ottawa Hospital, Queensway-Carleton Hospital, and Hôpital Montfort

排除标准

  • Anyone who is unable to participate in a virtual intervention

结局指标

主要结局

The Inventory for Complicated Grief-revised (ICG-r) Score at 6 Months Post-death

时间窗: at 6 months post-death

This tool, used to detect pathological grief, has a total of 19 questions. Respondents rate the frequency with which they experience each item on a 5-point scale (0-4), ranging from "never" to "always." Respondents with ICG-r scores greater than 25 are significantly more impaired in social, general, mental and physical health functioning and in bodily pain than those with ICG-r scores less than or equal to 25. Higher scores result in higher likelihood of CG.

The Inventory for Complicated Grief-revised (ICG-r) Score at 12 Months Post-death

时间窗: at 12 months post-death

Participating FMs will have a repeat ICG-r assessment (as described for primary outcome #1) at 12 months post-death.

Change in ICG-r Score From 6 Months to 12 Months Post-death

时间窗: at 12 months post-death relative to 6 months post-death

The relative changes in ICG-r scores (change in mean score with SD) between 6 and 12 months of family members who participate in the VSGs vs. those who do not will be compared as a measure of the efficacy of the VSG intervention

Qualitative Interviews Post-Virtual Support Group

时间窗: Through study completion, an average of 1 year

The data for this primary outcome could not be collected due to no participants completing the virtual support group intervention. As a result, no interviews could be conducted. Interviews with family member participants upon completion of the virtual support group intervention were to be conducted to determine usefulness for family members' bereavement process. This is a qualitative method of data collection so there is no scale or score.

次要结局

未报告次要终点

研究者

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

Peter Lawlor

Clinician Investigator

Ottawa Hospital Research Institute

研究点 (2)

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