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临床试验/NCT04772820
NCT04772820已完成不适用

The SOCIAL Study: Feasibility of Remote Home Support Coaches to Decrease the Physical and Psychological Impact of Social Distancing on Older Adults

Brigham and Women's Hospital4 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月15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
10
试验地点
4
主要终点
Physical Activity - Self-report survey to measure engagement in activities

研究概览

简要总结

The goal of this this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.

详细描述

The goal of this study is to develop and test the feasibility of a remotely delivered brief behavioral activation intervention to decrease the negative physical and psychological consequences of being homebound among older adults during the time of COVID.The intervention will focus on decreasing the impact of social isolation, inactivity and poor nutrition on old people during a time when many in-person social activities are not possible. It will be delivered through telephone and other communication tools that allow remote (i.e. not in person) communication over 10 sessions. Subjects will be a total of 60 people aged 75 years an older, who will be recruited from primary care in the Boston MA region and senior living facilities in the Baltimore MD region. Coaches will be trained using an on-line based modules developed to support this intervention. Self-report outcomes will be measured by telephone at baseline and 4-month follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Men or women who are 75 years or older
  • Must be a patient of Mass General Brigham affiliated with Primary Care Physician departments in Boston, MA OR be a resident of Brightview Senior Living and Assisted Living facilities near Baltimore, MD

排除标准

  • • Men or women who are 74 years and younger
  • Participants who are not affiliated with Primary Care Physician departments at Mass General Brigham or a resident of an assisted living facility in Baltimore, MD
  • Unable to adequately complete the Evaluation to Provide Consent

结局指标

主要结局

Physical Activity - Self-report survey to measure engagement in activities

时间窗: change from baseline to 4-month follow-up

Yale Physical Activity Survey (self-report)

Loneliness assessment - 20 item, self-report assessment to measure loneliness

时间窗: change from baseline to 4-month follow-up

UCLA Loneliness Scale 3.0 (self-report) 20 item, self-report assessment to measure loneliness. Scale from 1(never) to 4(often)

Physical Activity - step activity monitor to track daily steps walked

时间窗: change in steps from the first week of study to final week (week 16) of study

average steps walked per day

次要结局

  • PROMIS Short form to measure level 2 adult depression(change from baseline to 4-month follow up)
  • PROMIS short-form to measure anxiety in adults(change from baseline to 4-month follow up)
  • Late Life Function Instrument to assess functionality in elderly(change from baseline to 4-month follow up)
  • Late Life Function Instrument to access disability in elderly(change from baseline to 4-month follow up)
  • Duke Social Support short scale to measure social support among older people(change from baseline to 4-month follow up)
  • Mini-nutritional assessment to determine if there is risk of malnourishment(change from baseline to 4-month follow up)
  • Likert 0-7 rating scale of participants satisfaction with the program(4 month follow-up)

研究者

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

Shalendar Bhasin, MD

Principal Investigator

Brigham and Women's Hospital

研究点 (4)

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