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虚拟生活俱乐部的干预,以改善社区居民的孤独和冷漠 (LSC Feasible)

2026年9月22日 更新者:Montefiore Medical Center

虚拟生活俱乐部的干预措施,以改善社区居民老年人的孤独和冷漠:混合方法可行性研究

Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults. Group reminiscence therapy combines structured social engagement and recounting of personal stories that address both social connection (a risk factor for cognitive decline) and cognition. Life story club© (LSC) is an established, non-profit organization that provides virtual, group reminiscence therapy for older adults to reduce loneliness and promote a sense of belonging and has not been formally studied.

研究概览

地位

招聘中

详细说明

The purpose of this study is to explore the feasibility of a LSC© intervention to improve loneliness and apathy in community-dwelling older adults.

This pilot study will be conducted to compare loneliness and apathy in lonely individuals without dementia at baseline who receive a virtual group reminiscence therapy intervention (vGRT). The intervention will be delivered weekly over 12 weeks. Loneliness and apathy will be assessed before and after the intervention as described in the Outcome Measures section of this registration. Feasibility will be assessed using quantitative and qualitative measures including feasibility of screening and enrollment, acceptability, and program satisfaction. Qualitative interviews will be conducted with a subset of 30 individuals to explore acceptability, barriers, and facilitators of the intervention.

This study will provide evidence for the feasibility of a virtual group reminiscence therapy for community dwelling older adults to reduce loneliness and apathy. This approach is both innovative and pragmatic because it will leverage an existing community-based service, with an established infrastructure and track record within the community to deliver the intervention. As such, the proposed research has the potential for broad implications for community-based research and aligns with multiple translational science principles.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • New York
      • The Bronx、New York、美国、10467
        • 招聘中
        • Montefiore Medical Center
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 60 and over
  • English or Spanish fluency
  • Able to provide informed consent

Exclusion Criteria:

  • Dementia based on Aging and Dementia (AD8) score of ≥4 or previous dementia diagnosis
  • Severe auditory or visual loss
  • Lack of access to internet connection or phone

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Life Story Club

Virtual Group Reminiscence Therapy

Virtual group reminiscence therapy will be provided by the Life Story Club©. Participants will meet virtually via Zoom© with their group (6-10 people) weekly for one hour over a 12-week period to exchange life stories and share in conversation. Groups will be conducted in entirely in English or Spanish, based on participant preference. Each week, the LSC© facilitator will guide the group with question prompts to encourage participants to share personal information, build friendships & rapport, and create a sense of community. LSC© facilitators are trained in group interview techniques, technology management, and know how to respond appropriately to sensitive information that may emerge during group exchanges.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Loneliness
大体时间:From baseline to 3 months and 6 months

Loneliness will be assessed using the University of California, Los Angeles (UCLA) Loneliness Scale questionnaire. The UCLA Loneliness Scale is a 20-item measure that assesses how often a person feels disconnected from others. Participants provide responses using a 4-point Likert scale where 1 = never; 2 = rarely; 3 = sometimes; 4 = always, for an overall possible scoring range of 20-80, such that higher scores are associated with increased loneliness. Positively worded items in the questionnaire must be reverse-coded before reporting. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of an increase in loneliness from baseline and negative values a decrease in loneliness from baseline. Group scores will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months
Change in Apathy
大体时间:From baseline to 3 months and 6 months

Apathy will be assessed using the self-reported Apathy Evaluation Scale (AES-S). The AES-S is an 18-item questionnaire that addresses characteristics of goal directed behavior that reflects apathy including behavioral, cognitive, and emotional indicators. Participants provide responses based on a 4-point Likert scale where 1 = not at all true; 2 = slightly true; 3 = somewhat true; and 4 = very true, for an overall possible scoring range of 18-72, such that higher scores are associated with greater apathy. Positively worded items in the scale must be reverse-coded before reporting. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased apathy from baseline and negative values decreased apathy from baseline. Group scores will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in cognition
大体时间:From baseline to 3 months and 6 months

Cognition will be assessed using a version of the Telephone-Montreal Cognitive Assessment (T-MoCA). The T-MoCA is a 22-item phone-administered exam which assesses a range of global cognitive domains including attention, memory, language, and orientation. Each item is one point yielding an overall possible scoring range of 0-22, with higher scores being indicative of better cognitive function. Scores of 18 or below are generally suggestive of Mild Cognitive Impairment (MCI). For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased cognition from baseline and negative values decreased cognition from baseline. Group scores will be summarized using basic descriptive statistics. To reduce practice effect Version (V)8.1 will be administered at baseline, V8.2 at 3 months, and V8.3 at 6 months. Scoring ranges are identical for all 3 versions.

From baseline to 3 months and 6 months
Change in Meaning and Purpose
大体时间:From baseline to 3 months and 6 months

Meaning and purpose will be assessed as a composite measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose 4-item scale. The 4-item scale is designed to assess an individual's subjective experience of meaning and purpose in life. Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 4-20, such that higher scores are associated with greater meaning and purpose. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased experiences of meaning and purpose from baseline and negative values decreased experiences of meaning and purpose from baseline. Group results will be summarized using basic descriptive statistics

From baseline to 3 months and 6 months
Change in Depressive Symptoms
大体时间:From baseline to 3 months and 6 months

Depressive symptoms will be assessed by administration of the Geriatric Depression Scale - Short Form (GDS-15), The GDS-15 is a 15-item questionnaire in which participants provide a dichotomous (Yes/No) response as to how they have felt over the prior week. Answers suggestive of depression are bolded/italicized on the questionnaire (may either be 'Yes' or 'No' depending on the item). A score of 1 point is assigned for each bolded/italicized response such that higher scores are associated with more depressive symptoms. A score of 0 to 5 is normal. A score greater than 5 suggests depression. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increase in depressive symptoms from baseline and negative values a decrease in depressive symptoms from baseline. Results will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months
Change in Social Support
大体时间:From baseline to 3 months and 6 months

Social Support will be assessed using the Medical Outcomes Study (MOS) Social Support Scale. The MOS is a 19-item multidimensional, self-administered instrument that measures the availability of support, if needed. The overall social support component of the MOS Social Support scale will be used. Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 19-95, such that higher scores are associated with greater availability of social support. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased social support and purpose from baseline and negative values decreased social support from baseline. Group results will be summarized using basic descriptive statistics

From baseline to 3 months and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mirnova Ceide, MD、Montefiore Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月15日

初级完成 (估计的)

2027年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2025年3月26日

首先提交符合 QC 标准的

2025年4月2日

首次发布 (实际的)

2025年4月9日

研究记录更新

最后更新发布 (实际的)

2026年9月25日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2025-16787
  • UM1TR004400 (美国 NIH 拨款/合同)
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Data sharing to be determined.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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