OASIS：阿巴拉契亚 T2DM 同行支持 (OASIS)
2026年6月15日 更新者：The University of Texas Medical Branch, Galveston
老年人利用社会支持来改善自我保健：阿巴拉契亚地区 T2DM 老年人同伴支持的适应、实施和可行性。
这项临床试验的目的是比较同伴辅导模式对患有未控制的二型糖尿病的老年人的效果。 它旨在回答的主要问题是：
- 同伴辅导模式能否有效促进 2 型糖尿病自我管理？
- 如果有效，同行模型的哪些方面最有效？ 同行教练将
- 接受同伴教练培训。
- 每周/每两周与同行参与者联系一次，讨论自我管理和目标设定。
- 保留联系记录、讨论的主题以及互动的一般说明。 研究人员将比较接触频率的差异，以及同伴教练与同伴参与者的匹配方式，以了解干预的效果在各组之间是否有所改变。
研究概览
地位
招聘中
条件
详细说明
老年人利用社会支持改善自我保健 (OASIS) 干预是一种基于资产的方法，利用肯塔基州阿巴拉契亚农村社区现有的独特社会结构来解决与 2 型糖尿病 (T2DM) 相关的自我保健行为管理。
干预措施将由两组组成：已控制 T2DM (HbA1c < 7.5%) 的同伴教练，以及未控制 T2DM (HbA1c> 7.5%) 的同伴参与者。
同伴教练将在干预开始之前接受培训，以培养教练技能。
同伴参与者将通过以下四种方式之一与同伴教练联系： (1) 自选教练，每周联系一次 (2) 自选教练，每两周联系一次 (3) 与同伴教练匹配，每周联系一次第（4）周与同伴教练进行匹配，每两周进行一次联系。
除了评估同伴辅导模型的有效性之外，还将对四个小组进行评估，以便更详细地了解影响自我保健行为的因素。
利益相关者还将在三个时间点参与：干预之前、研究中期和研究结束时。
研究结束时，一小群同行参与者和同行教练将被邀请参与利益相关者小组访谈。
与利益相关者的信息交流将有助于深入了解影响因素以及如何有效地推广干预措施。
研究类型
介入性
注册 (估计的)
25
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
- 姓名：Brittany L. Smalls, PhD
- 电话号码：409-772-1011
- 邮箱：blsmalls@utmb.edu
研究联系人备份
- 姓名：Kindness C. Akwari, MS
- 电话号码：502-627-0591
- 邮箱：kcakwari@utmb.edu
学习地点
-
-
Kentucky
-
Bowling Green、Kentucky、美国、42101
- 招聘中
- Barren River Area Development District
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接触：
- Alecia Johnson
- 电话号码：270-781-2381
- 邮箱：alecia.johnson@bradd.org
-
Hazard、Kentucky、美国、41701
- 招聘中
- UK HealthCare
-
接触：
- Key Douthitt, MD
- 电话号码：606-439-1559
- 邮箱：key.douthitt@uky.edu
-
-
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
- 成人
- 年长者
接受健康志愿者
不
研究人群
- 年龄大于或等于55岁
- 肯塔基州农村居民
- 2 型糖尿病的阳性诊断
- 同伴教练的 HbA1c 低于 7.5
- 通过研究人员进行的认知评估分数
- 英语会话
描述
纳入标准：
- 年龄大于或等于55岁
- 肯塔基州农村居民
- 2 型糖尿病的阳性诊断
- 同伴参与者的 HbA1c 大于 7.5
- 同伴教练的 HbA1c 低于 7.5
- 通过研究人员进行的认知评估分数
- 英语会话
排除标准：
- 年龄小于55岁
- 不是肯塔基州乡村县的居民
- 认知障碍
- 非英语口语
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：卫生服务研究
- 分配：随机化
- 介入模型：阶乘赋值
- 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：Peer Participants (A)
Peer participants in group A will self select a peer coach using peer coach profile sheets, and will be contacted weekly during the intervention period.
|
Peer participants in group A will be contacted by peer coaches on a weekly basis.
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实验性的：Peer Participants (B)
Peer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted every 2 weeks during the intervention period.
|
Peer participants in group B will be contacted by peer coaches on a bi-weekly basis.
|
|
实验性的：Peer Participants (C)
Peer participants in group C will be matched with a peer coach and will be contacted weekly during the intervention period.
|
Peer participants in group C will be contacted by peer coaches on a weekly basis.
|
|
实验性的：Peer Participants (D)
Peer participants in group D will be matched with a peer coach and will be contacted every 2 weeks during the intervention period.
|
Peer participants in group D will be contacted by peer coaches on a bi-weekly basis.
|
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 |
|---|---|---|
|
Number of Participants with Change in A1c
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
Obtained using point of care assessment
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diabetes Empowerment
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Attitudes Towards Diabetes - DES". 5 point scale ranging from 1 "Strongly Agree" to 5 "Strongly Disagree", where lower scores indicate greater feelings of empowerment.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Quality of Life Index
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"EuroQofL-5D" measures acts of daily living (ADL) on a five point scale ranging from 0 "no" problems to 5 "extreme" problems, where higher scores indicate lower ability to engage in ADL.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
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Social Support
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"MOS Social Support Survey" a five point scale ranging from 1 "none of the time" to 5 "all of the time" where higher scores indicate better social support.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Depression Scale
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Geriatric Depression Scale: Short Form" is a binary survey where participants can select "yes" or "no".
Each "yes" is a singular point, if a score >5 points it is suggestive about depression and warrant a follow-up comprehensive assessment.
A score of greater than or equal to 10 is almost always indicative of depression.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Problem Areas in Diabetes
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Problem Areas In Diabetes (PAID) Scale" a five point scale ranging from 0 "not a problem" to 4 "serious problem", where a higher score indicates more problems in diabetes management.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Diabetes Self-Management
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
Diabetes Self-Management Questionnaire (DSMQ) is a four point scale ranging from 0 "does not apply to me" to 3 "applies to me very much".
Higher scores indicate better diabetes management.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Social Network Scale
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Lubbens Social Network Scale - 6 (LSNS-6) is a five point scale ranging from "0" none to "5" nine or more.
Higher scores indicate greater amount of social support.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Diabetes Knowledge Questionnaire
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Diabetes Knowledge Questionnaire (DKQ)" is a 24-item survey that has shown sensitivity to a diabetes knowledge intervention; additionally, it targets knowledge deficits which can be related to measurable outcomes, false statements, or common and/or serious misconceptions.
Participants can select "yes", "no", or "don't know".
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Problem Solving Skills
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Diabetes Problem-Solving Inventory (DPSI)" includes 9 items that assess how individuals living with diabetes cope with challenges of T2D-related self-care.
The inventory measures three components: healthy eating, physical activity, and stress management.
Overall problem-solving rating is provided on a 5-point scale from 1 "(very poor strategy)" to 5 "(excellent strategy)".
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Brooks Medication Adherence
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Brooks Medication Adherence Scale" is a 6-item scale and is sensitive to changes in adherence due to intervention.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Frailty
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Pictorial Fit-Frail Scale" measures frailty phenotype using a validated assessment that characterizes frailty by exhaustion, low physical activity, weakness, and low body mass index.
Individuals are characterized as frail if they have affirmative responses to 3 or 4 of the items.
By identifying frailty phenotype, individuals at increased risk for adverse health outcomes can be identified, which serves as an indicator for complex patient management.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
|
Acts of Daily Living
大体时间：Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
"Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.) is a binary where "0" is low functioning and "1" is high functioning.
Higher scores indicate higher functioning.
|
Collected at Baseline, 6 months (at the end of the intervention), 3-months and 6-months post-intervention.
|
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：Brittany L. Smalls, PhD、University of Texas Medial Branch
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。
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)
2023年11月20日
初级完成 (估计的)
2027年3月31日
研究完成 (估计的)
2027年3月31日
研究注册日期
首次提交
2023年7月31日
首先提交符合 QC 标准的
2023年8月14日
首次发布 (实际的)
2023年8月22日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6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.