Telephone Calls for Health for Homebound Older Adults
2021年3月26日 更新者：Maninder Kahlon、University of Texas at Austin
A randomized controlled trial of the effect of 4 weeks of regular check-in calls, up to 5 per week based on participant's choice and 2 survey collection calls and possible referral of other services, versus no daily check-in calls, on self-reported loneliness measures for current Meals on Wheels participants (MOW).
研究概览
详细说明
The intervention arm will include 125 MOW clients to receive a call of between 5 - 10 minutes in length each by a consistent caller, five times a week, Monday through Friday for 4 consecutive weeks to check in on them. After the first week of calls, subjects in the intervention arm will be asked if the frequency of calls is acceptable or if they would like to reduce the call frequency, potentially to a minimum of twice per week.
Brief guidance and training will be provided for the daily conversation to maximize time spent speaking by the recipient but otherwise, the calls are unscripted other than specific prompts to ask about the recipient's general sense of well-being. "How are you doing today?"
The control Arm will include 125 MOW clients who will be randomized to a control group that will not receive the intervention calls. The control group will receive calls from a member of the research team at the beginning of the study to collect baseline survey data and at the post-4-week period to collect post-study survey data.
研究类型
介入性
注册 (实际的)
240
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。
学习地点
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Texas
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Austin、Texas、美国、78712
- University of Texas at Austin
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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
18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:
- Adult (18+) clients of Meals on Wheels of Central Texas
Exclusion Criteria:
- Cognitive impairment or in a hospice program.
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：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention - Calls
Participants randomized to the intervention will receive a call of between 5 - 10 minutes in length each by a consistent caller, five times a week, Monday through Friday for 4 consecutive weeks to check in on them.
After the first week of calls, subjects in the intervention arm will be asked if the frequency of calls is acceptable or if they would like to reduce the call frequency, potentially to a minimum of twice per week.
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Calls were made by volunteers trained to engage with participants.
Call structure was unscripted and call length was recommended to be between 5-10 min.
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无干预：Control - No calls
Participants randomized to a control group will not receive the intervention calls.
The control group will receive calls from a member of the research team at the beginning of the study to collect baseline survey data and at the post-4-week period to collect post-study survey data.
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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 |
|---|---|---|
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Loneliness as assessed by the De Jong Gierveld Loneliness Scale
大体时间：4 weeks
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Investigators will use the De Jong Gierveld Loneliness 6-Item Scale for Overall, Emotional, and Social Loneliness.
Scored from 0-6, a score of 0 indicates least lonely while a score of 6 indicates most lonely.
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4 weeks
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Loneliness as Assessed by the UCLA Short Scale for Measuring Loneliness in Large Surveys
大体时间：4 weeks
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Investigators will use the UCLA Short Scale for Measuring Loneliness in Large Surveys to measure loneliness.
Scored from 3-9, higher scores indicate greater degrees of loneliness.
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4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Depression as Assessed by the 8-item Depression Health Questionnaire (PHQ-8)
大体时间：4 weeks
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Investigators will use the Depression Patient Health Questionnaire (PHQ-8) to measure depression.
Scored from 0-3, and a score of 0 indicates lower levels of depression while a score of 3 indicates higher levels of depression.
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4 weeks
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Anxiety as Assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
大体时间：4 weeks
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Investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to measure anxiety.
Scored from 0-3, and a score of 0 indicates lower levels of anxiety while a score of 3 indicates higher levels of anxiety.
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4 weeks
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Health Status and Quality of Life as Assessed by the Short Form-12 Question Survey
大体时间：4 weeks
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Investigators will use the Short Form-12 question survey to measure physical and mental health status.
Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.
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4 weeks
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Social Engagement as Assess by the Short Lubben Social Network Scale (LSNS)
大体时间：4 weeks
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Investigators will use the 6-item Short Lubben Social Network Scale to measure social engagement.
For the LSNS-6, the score ranges between 0 and 30, with a higher score indicating more social engagement.
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4 weeks
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Empathy as Assessed by The Consultation and Relational Empathy (CARE) Measure
大体时间：After the 4 week intervention (follow-up)
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Investigators will use the CARE Measure to evaluate measures of empathy in the context of the caller/participant relationship
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After the 4 week intervention (follow-up)
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Toronto Empathy Questionnaire
大体时间：Prior to the 4 week intervention (baseline)
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The Toronto Empathy Questionnaire will be used to assess characteristics of callers that align with measures of ability to be empathetic.
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Prior to the 4 week intervention (baseline)
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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。
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
- Holt-Lunstad J, Smith TB, Baker M, Harris T, Stephenson D. Loneliness and social isolation as risk factors for mortality: a meta-analytic review. Perspect Psychol Sci. 2015 Mar;10(2):227-37. doi: 10.1177/1745691614568352.
- Anderson, G., Thayer, C. . Loneliness and Social Connections: A National Survey of Adults 45 and Older. Washington, DC: AARP Research, September 2018. https://doi.org/10.26419/res.00246.001.
- Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. doi: 10.1037/0882-7974.21.1.140.
- Steger MF, Kashdan TB. Depression and Everyday Social Activity, Belonging, and Well-Being. J Couns Psychol. 2009 Apr;56(2):289-300. doi: 10.1037/a0015416.
- Derksen F, Bensing J, Lagro-Janssen A. Effectiveness of empathy in general practice: a systematic review. Br J Gen Pract. 2013 Jan;63(606):e76-84. doi: 10.3399/bjgp13X660814.
- Kahlon MK, Aksan N, Aubrey R, Clark N, Cowley-Morillo M, Jacobs EA, Mundhenk R, Sebastian KR, Tomlinson S. Effect of Layperson-Delivered, Empathy-Focused Program of Telephone Calls on Loneliness, Depression, and Anxiety Among Adults During the COVID-19 Pandemic: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Jun 1;78(6):616-622. doi: 10.1001/jamapsychiatry.2021.0113.
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)
2020年7月6日
初级完成 (实际的)
2020年9月24日
研究完成 (实际的)
2020年9月26日
研究注册日期
首次提交
2020年10月14日
首先提交符合 QC 标准的
2020年10月14日
首次发布 (实际的)
2020年10月20日
研究记录更新
最后更新发布 (实际的)
2021年3月30日
上次提交的符合 QC 标准的更新
2021年3月26日
最后验证
2021年3月1日
更多信息
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.