Improving Medication Adherence Among Underserved Patients With Type 2 Diabetes
2020年8月6日 更新者：Lindsay Mayberry、Vanderbilt University Medical Center
This study evaluates a mobile phone-delivered intervention, called REACH (Rapid Education/Encouragement And Communications for Health), in supporting adults with type 2 diabetes in their self-management relative to a control group.
The goal of this study is to determine if individually tailored content (based on the Information-Motivation-Behavioral Skills Model) delivered to the participant via text messages can improve the participant's glycemic control and adherence to diabetes medications.
We will test whether our intervention improves adherence-related information, motivation, and behavioral skills and whether improving these mechanisms drives improvements in adherence and, in turn, glycemic control.
研究概览
研究类型
介入性
注册 (实际的)
512
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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Tennessee
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Nashville、Tennessee、美国、37203
- Federally Qualified Health Centers and Vanderbilt Primary Care Clinics
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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 aged 18 years and older
- Individuals who have received a diagnosis for type 2 diabetes mellitus
- Enrolled as a patient at a participating community health center
- Individuals currently being treated with oral and/or injectable diabetes medications
Exclusion Criteria:
- Non-English speakers
- Individuals who report they do not have a cell phone
- Individuals unwilling and/or not able to provide written informed consent
- Individuals with unintelligible speech (e.g., dysarthria)
- Individuals with a severe hearing or visual impairment
- Individuals who report a caregiver administers their diabetes medications Individuals who fail the cognitive screener administered during the baseline survey
- Individuals who cannot receive, read, and respond to a text after instruction from a trained research assistant
- Individuals whose most recent (within 12 months) HbA1c value was 6.8% or greater
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：支持治疗
- 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：REACH
Participants will receive REACH text messages (individual-focused text messaging tailored to user's individual barriers to adherence and targeted to address other self-care behaviors) for 12 months. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
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实验性的：REACH + FAMS
In addition to the REACH text messages tailored to user's individual barriers to adherence, participants will receive FAMS components (monthly phone coaching and text messages supporting a goal set in coaching, plus the option to invite a family member/support person to receive text messages) for six months. After six months, participants in this arm will receive REACH text messages only. All participants will also receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.
其他名称：
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有源比较器：Helpline and A1c results
Participants assigned to the control group will complete measures at each time point and maintain care as usual (i.e., medical treatment and physician monitoring). All participants will receive text messages advising how to access their study A1c test results, receive quarterly newsletters on healthy living with diabetes, and have access to a Helpline for study- and diabetes medication-related questions. |
Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
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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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Change in Glycemic Control as Indicated by Hemoglobin A1c (HbA1c)
大体时间：Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by Hemoglobin A1c (%) with higher values indicating worse glycemic control and an improvement of 0.5% considered clinically meaningful
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Baseline, 3 months, 6 months, 12 months, 15 months
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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 Self-reported Medication Adherence
大体时间：Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by the Summary of Diabetes Self-Care Activities (SDSCA) Medications subscale; response options are days in the last week ranging from 0 to 7, with 7 representing perfect adherence
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Self-reported Medication Adherence
大体时间：Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by the Adherence to Refills and Medications Scale for Diabetes (ARMS-D); reverse coded such that higher scores indicate better adherence on a scale from 11 to 44
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Baseline, 3 months, 6 months, 12 months, 15 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Adherence to Dietary Behavior
大体时间：Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by the Personal Diabetes Questionnaire diet subscale "Use of information for decision making"; possible range 1-6, higher indicates more use of dietary information (better)
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Adherence to Dietary Behavior
大体时间：Baseline, 3 months, 6 months, 12 months, 15 months
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Personal Diabetes Questionnaire diet subscale "Problem eating behavior"; possible range 1-6 with higher indicating more problem eating behavior (worse)
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Physical Activity
大体时间：Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by International Physical Activity Questionnaire-Short form [metabolic equivalent minutes (MET-minutes) per week] where more MET-minutes per week indicates more physical activity
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Baseline, 3 months, 6 months, 12 months, 15 months
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Change in Glycemic Control - REACH Only vs. Control & REACH+FAMS vs. Control
大体时间：Baseline, 3 months, 6 months, 12 months, 15 months
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as measured by hemoglobin A1c (HbA1c, %) We may be under-powered to for these comparative analyses.
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Baseline, 3 months, 6 months, 12 months, 15 months
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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。
调查人员
- 首席研究员：Lindsay S Mayberry, MS, PhD、Vanderbilt University 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
- Nelson LA, Mayberry LS, Wallston K, Kripalani S, Bergner EM, Osborn CY. Development and Usability of REACH: A Tailored Theory-Based Text Messaging Intervention for Disadvantaged Adults With Type 2 Diabetes. JMIR Hum Factors. 2016 Sep 8;3(2):e23. doi: 10.2196/humanfactors.6029.
- Nelson LA, Wallston KA, Kripalani S, Greevy RA Jr, Elasy TA, Bergner EM, Gentry CK, Mayberry LS. Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 10;7(4):e92. doi: 10.2196/resprot.9443.
- Roddy MK, Mayberry LS, Nair D, Cavanaugh KL. Exploring mHealth potential to improve kidney function: secondary analysis of a randomized trial of diabetes self-care in diverse adults. BMC Nephrol. 2022 Aug 10;23(1):280. doi: 10.1186/s12882-022-02885-6.
- Mayberry LS, Bergner EM, Harper KJ, Laing S, Berg CA. Text messaging to engage friends/family in diabetes self-management support: acceptability and potential to address disparities. J Am Med Inform Assoc. 2019 Oct 1;26(10):1099-1108. doi: 10.1093/jamia/ocz091.
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)
2016年5月23日
初级完成 (实际的)
2019年6月4日
研究完成 (实际的)
2019年6月4日
研究注册日期
首次提交
2015年3月9日
首先提交符合 QC 标准的
2015年3月31日
首次发布 (估计)
2015年4月6日
研究记录更新
最后更新发布 (实际的)
2020年8月17日
上次提交的符合 QC 标准的更新
2020年8月6日
最后验证
2020年8月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Individual participant data collected during the trial will be de-identified and made available following publication of the 15-month trial results to researchers who provide a methodologically sound proposal.
IPD 共享时间框架
Beginning 6 months after final trial results publication.
No end date.
IPD 共享访问标准
Approval of a proposal by the study PI.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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.
REACH的临床试验
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Salem Veterans Affairs Medical CenterUnited States Department of Defense; Virginia Polytechnic Institute and State University; VA Boston...完全的
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University of Southern CaliforniaUniversity of California, Los Angeles; University of California, Irvine招聘中
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City University of Hong KongStanford University; Harvard University完全的
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Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)尚未招聘
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University of California, DavisUniversity of Minnesota; National Geriatric Hospital完全的
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New York State Psychiatric InstituteNational Institute of Mental Health (NIMH); Columbia University; Brown University暂停
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Memphis VA Medical CenterU.S. Army Medical Research and Development Command完全的
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Wuerzburg University HospitalUniversity of Leipzig; University of Wuerzburg; Campus Bad Neustadt; Klinikum Aschaffenburg-Alzenau 和其他合作者完全的