Developing Affective HeaLth to Improve Adherence to Health Behaviors in Diabetes (DAHLIA II)
2022年7月15日 更新者：Happify Inc.
Participants will be randomly assigned to either a positive affect skills intervention or a psychoeducation control group and assessed with questionnaires before, during, and after the 8-week program, as well as at 3 months, 6 months, and 12 months after the end of the program.
研究概览
详细说明
Participants will be randomly assigned to either the Diabetes positive affect skills intervention or a psychoeducation control group.
Both programs last 8 weeks and take place on a simplified research version of the Happify platform.
Participants assigned to the diabetes positive affect program will have full access to Happify, with a track that focuses on building skills for greater happiness, reducing stress, and coping better with diabetes displayed as the feature track.
Participants assigned to the psychoeducation (control) condition will be asked to complete a series of polls on various wellbeing topics, and then provided with some social comparison data about how their responses compared with the responses of other users, as well as information about why the well being topic is important.
Participants will be asked to complete questionnaires before, during, and after the 8-week program as well as 3 months, 6 months and 12 months follow-up questionnaires after the program is complete, at which point study participation will end.
研究类型
介入性
注册 (实际的)
14
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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New York
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New York、New York、美国、10012
- Happify (an online platform -- study is entirely online)
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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:
- Adults with Type 2 Diabetes
- Elevated HbA1c levels (7 or greater)
- No prior experience on the Happify platform (new user registration)
- PHQ-8 score of 13 or higher
- US resident
- Under the care of a medical professional for the treatment of their diabetes
- Be willing and able to obtain HbA1c every 3 months
Exclusion Criteria:
- none
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：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Positive affect condition
Participants use Happify and have the option to use a diabetes-specific track that focuses on building skills for greater happiness, reducing stress, and coping better with diabetes.
Users may access a wide variety of 4-week programs and use them in any way they desire for the entire study period.
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一个在线平台，用于传达积极心理学、认知行为疗法和基于正念的减压技术。
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假比较器：心理教育情况
参与者在 Happify 上完成一系列测验和民意调查，旨在让他们思考幸福主题，但没有给出任何关于如何促进幸福的具体说明。
参与者可以访问 8 周的内容，但可以在后续期间随意重复内容。
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一个在线平台，用于传达积极心理学、认知行为疗法和基于正念的减压技术。
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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 |
|---|---|---|
|
Change in self-reported HbA1C level
大体时间：Baseline, 3 weeks post-intervention (day 83), 3 weeks after 3-month post intervention (day 173), 3 weeks after 6 month post intervention (day 263), and 12 months post intervention (day 416)
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1-item self-reported measure of Hemoglobin A1C (HbA1C) level, "What was your most recent HbA1c level?"
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Baseline, 3 weeks post-intervention (day 83), 3 weeks after 3-month post intervention (day 173), 3 weeks after 6 month post intervention (day 263), and 12 months post intervention (day 416)
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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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Change in Depression symptoms [PHQ-9 questionnaire]
大体时间：Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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9-item measure of depressive symptoms scoring how often the participant has been bothered by each statement over the past 2 weeks from not at all (0) to nearly every day (3).
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Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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Change in Diabetes Regimen Adherence
大体时间：From baseline up to 63 days, 7 days at 3 months post intervention (146-153), 7 days at 6 months post intervention (236-243), and 12 months post intervention (day 416-423)
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1-item measure on keeping up with diabetes regimen in the past 24 hours, asking "Which of the following activities in your diabetes regimen did you complete over the past 24 hours?"
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From baseline up to 63 days, 7 days at 3 months post intervention (146-153), 7 days at 6 months post intervention (236-243), and 12 months post intervention (day 416-423)
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Change in Perceived Stress [Perceived Stress Scale (PSS)]
大体时间：Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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10-item measure of perceived stress scoring how often the participant felt stressed by each statement in the following month from never (0) to very often (4).
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Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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Change in diabetes self-care activities [Summary of Diabetes Self-Care Activities (SDSCA)]
大体时间：Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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11-item measure of self-reported adherence to diabetes self-care activities, ex.
"On how many of the last seven days did you participate in at least 30 minutes of physical activity?" with possible answers of 0 to 7 days for each question.
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Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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Change in positive affect [Patient-Reported Outcomes Measurement Information Systems - Positive Affect Subscale(PROMIS)]
大体时间：Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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15-item measure of positive affect scoring participants on how often then felt each statement was true over the past 7 days from not at all (1) to very much (5)
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Baseline, immediate post-intervention at 8 weeks, and at 3, 6, and 12 months post-intervention
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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。
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8月31日
初级完成 (实际的)
2021年4月1日
研究完成 (实际的)
2022年7月12日
研究注册日期
首次提交
2019年8月23日
首先提交符合 QC 标准的
2019年8月23日
首次发布 (实际的)
2019年8月28日
研究记录更新
最后更新发布 (实际的)
2022年7月19日
上次提交的符合 QC 标准的更新
2022年7月15日
最后验证
2022年7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.