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临床试验/NCT04662008
NCT04662008已完成不适用

CLOSER_MS: Communicating With Local or Distance Caregivers Offering Support and Electronic Resources

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2021年3月10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
151
试验地点
2
主要终点
anxiety, depression, and stress (DASS-42)

研究概览

简要总结

This study is an enhancement of the Fatigue Management Programs for People with MS study (NCT03550170). The purpose of this randomized clinical trial is to test the effectiveness of two interventions delivered remotely to support unpaid caregivers (UC) of people with multiple sclerosis (MS). We hypothesize that a high resource intervention will be significantly better than a lower resource intervention in terms of the primary outcome (UC anxiety, depression, and stress) and secondary outcome (COVID specific anxiety).

详细描述

UCs are often caring for persons with chronic disabling conditions, who are at higher risk for severe COVID-19 illness. This presents incredibly stressful situations for UCs, which can result in depression, anxiety, and worse health outcomes both for them and their care recipients. Until a vaccine becomes available, these demands will force UCs to provide more support, whether in-person or remotely, for persons with MS. The aim of this study is to compare 2 modes of supporting UCs of people with MS. We will compare the effectiveness of a high resource highly tailored intervention that includes tele-coaching intervention (delivered via videoconference or phone) + web site information to a low-resource web-site only intervention. Our primary outcomes are UC anxiety, depression, and stress (DASS-42 scale) and a secondary outcome is COVID specific anxiety (CAS scale). These 2 interventions were selected because they will inform administrators and clinicians on whether a resource-intensive or a low-resource intervention is needed to yield meaningful outcomes. The comparison will also help UC decide how they should spend their limited time. These interventions are relevant to UCs of people with MS because of their need for tailored information provided in flexible ways to promote learning and support.

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

  • An adult family member or friend (18 years of age or older) of a person with MS
  • Self-identified as an unpaid caregiver for person with MS
  • Access to internet
  • Capable of providing informed consent in English

排除标准

  • Under age 18
  • Cannot speak English
  • Unable to provide consent
  • No access to the internet

结局指标

主要结局

anxiety, depression, and stress (DASS-42)

时间窗: Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks

Change from baseline in anxiety, depression, and stress levels. Each of the three DASS scales contains 14 items. Using a 4-point Likert scale, scores range from 0- 42 for each scale. Higher scores indicate more depression, anxiety, and stress.

次要结局

  • COVID specific anxiety (CAS scale)(Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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