跳至主要内容
临床试验/NCT05792852
NCT05792852招募中不适用

Feasibility of ENGAGE to Address Social Isolation Related to the COVID-19 Pandemic

University of Illinois at Chicago2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
21
试验地点
2
主要终点
Intervention Feasibility

研究概览

简要总结

This is a single-arm community-based feasibility study examining recruitment, retention, adherence, and satisfaction with ENGAGE, a community-based intervention designed to address pandemic-related social isolation among people with disabilities. We will also examine preliminary, within-group effects on social participation. The findings of this study will inform a larger trial to examine intervention efficacy.

详细描述

Social isolation has been shown to negatively affect physical and mental health, particularly among people with disabilities. Social isolation among people with disabilities has been exacerbated by the COVID-19 pandemic. Even now, people with disabilities remain hesitant to return to social and community activities due to ongoing risk of severe cases and death. Yet, we do not have strong models of intervention designed to address this problem.

ENGAGE is an intervention that may address this gap. ENGAGE was designed to address social and community participation among people with stroke. We have since conducted qualitative research to inform adaptation of ENGAGE to meet the needs of a broader range of people with disabilities related to participation in the context of the ongoing COVID-19 pandemic. This study is the next step in testing and refining the adapted intervention protocol. At the end of this study, we will have a finalized adapted intervention protocol ready for large-scale efficacy testing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Self-identify as disabled
  • Report problems with social participation
  • Speak English
  • Live in a community setting

排除标准

  • Severe communication impairment limiting ability to verbally indicate interest in participation

结局指标

主要结局

Intervention Feasibility

时间窗: 8 weeks

Recruitment (5-7 participants per group recruited within one month), retention (80% of participants complete follow up assessments), adherence (80% of participants complete the intervention group

Intervention Satisfaction

时间窗: 8 weeks

Client Satisfaction Questionnaire-8: 8-item scale of intervention satisfaction with a 32-point scale (higher scores indicate greater satisfaction). We will establish adequate acceptability if we achieve a mean score of 24 or greater.

次要结局

  • Social Participation(8 weeks)

研究者

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

Joy M Hammel

Professor

University of Illinois at Chicago

研究点 (2)

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