Medical Care, Education, Social Support, And Goal-setting to Empower Self-management for Diabetes (MESSAGES)
2022年11月1日 更新者：University of Chicago
Diabetes MESSAGES (Medical Care, Education, Social Support, And Goal-setting to Empower Self-management): Implementing Diabetes Group Visits and Text Messaging in Community Health Centers
Diabetes group visits, shared appointments where patients receive self-management education in a group setting and have a medical visit, are a promising way to deliver high quality diabetes care.
Group visits can improve glycemic control and decrease healthcare utilization.
To date, no studies have systematically implemented a diabetes group visit intervention in a network of U.S. community health centers.
The University of Chicago is partnering with Midwest Clinicians' Network (MWCN), a member organization of 130 health centers across ten Midwestern states.
Approximately half of all Federally Qualified Health Centers in this region are affiliated with MWCN.
The objectives of the study are [1] providers and staff at 20 health centers will have the requisite knowledge, skills, and motivation to implement a diabetes group visit plus text messaging intervention at their sites; [2] changes in diabetes processes of care; knowledge, attitudes, and skills for diabetes self-management; clinical outcomes; and health care utilization for patients participating in the diabetes group visit program will be evaluated; and [3] the diabetes group visit program will be available for dissemination among and use by health centers and healthcare providers at the local, state, regional, and national levels.
研究概览
详细说明
UChicago and MWCN will recruit and enroll 20 health centers (HCs) to participate in a training intervention and to implement diabetes group visit and text messaging programs at their clinic sites.
Each HC will assemble a team of 3-4 providers and staff to participate in the training.
HCs will be randomized to one of two training cohorts.
HC providers and staff will attend two in-person Learning Sessions in Chicago and a series of monthly webinars, recruit and enroll patients, implement a 6-month diabetes group visit and text messaging program plus subsequent booster sessions, complete periodic surveys and interviews, assist with data collection through patient surveys and chart abstraction, and present their program to peer HCs during Learning Sessions and to local stakeholders, state primary care organizations, or other professional groups.
Each HC will enroll 15 patients in the group visit and text messaging program; the 2018 Training Cohort will do so immediately following their enrollment in the study and the 2020 Training Cohort will do so after 18 months.
During the first 18 months, the 2020 Training Cohort will collect data from electronic health records (EHR) of randomly selected patients to serve as a control group.
Changes in self-reported outcomes, diabetes processes of care, and clinical outcomes will be assessed for intervention patients from baseline through 2 year follow up, and processes of care and clinical outcomes will be compared for intervention vs. control participants.
Capacity of HC providers and staff to conduct a group visit and text messaging intervention for patients with diabetes, as well as their confidence in identifying and addressing health disparities, will be evaluated through surveys and in-depth interviews.
This study will expand knowledge of the barriers, facilitators, and perceived benefits and drawbacks of group visit and text messaging interventions and inform the development of a toolkit that will be disseminated to other HCs.
研究类型
介入性
注册 (实际的)
265
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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Illinois
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Chicago、Illinois、美国、60637
- University of Chicago
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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:
- 18 years or older
- diagnosis of type 2 diabetes
- attended at least two appointments at the HC within the past year, with at least one of them being during the past six months
- last documented A1c result greater than or equal to 8.0% (test must have been done during the last 6 months)
- own a cellular phone with text messaging capabilities
- have the ability to read and send text messages
- English or Spanish speaking
Exclusion Criteria:
- pregnant or planning to become pregnant
- uncontrolled psychiatric problem
- dementia or other cognitive impairment
- hearing difficulties or severe physical disability that would prevent them from participation in group visit
- planning to relocate in the next year or leave the area during the group visit period
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：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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实验性的：2018 Training Cohort
10 health centers will be randomized to the 2018 Training Cohort.
Teams from these health centers will be trained and will implement a 6 month diabetes group visit and text messaging intervention (Diabetes MESSAGES Program).
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Health centers in the 2018 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient.
At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program.
Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
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其他：2020 Training Cohort
10 health centers will be randomized to the 2020 Training Cohort.
Prior to beginning training, these health centers will collect data on randomly selected patients receiving usual care to serve as the control group.
After this first parallel group trial period, teams from these health centers will be trained and will implement the 6 month diabetes group visit and text messaging intervention during a second single group trial period (Diabetes MESSAGES Program (second trial)).
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During the first trial period, health centers in the 2020 Training Cohort will collect data on patients receiving usual care.
After the first trial period, health centers in the 2020 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient.
At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program.
Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Hemoglobin A1C
大体时间：change from baseline to 12 months
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change from baseline to 12 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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Hemoglobin A1C
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Blood pressure
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Weight
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Cholesterol
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Diabetes processes of care
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Receipt of recommended screenings, exams, referrals, and vaccinations
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Medication management of diabetes
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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changes in prescribed diabetes medications for patients with inadequate diabetes control
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of hypoglycemic events
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Number of hospital admissions
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Number of primary care, specialist, and ER visits
大体时间：baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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baseline, 6 month, and 18 month for intervention vs. control patients; 30 month for intervention patients only
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Smoking status
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Health related quality of life (SF-12)
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Depression (PHQ-2)
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Summary of Diabetes Self-Care Activities Measure
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Understanding of Diabetes Self-Management (Diabetes Care Profile)
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Attitudes Towards Diabetes (Diabetes Care Profile)
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Distress Scale (DDS-2)
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Quality of Life Scale
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Self-Empowerment Scale
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Diabetes Social Support Scale
大体时间：baseline, 6 month, and 12 month for intervention patients only
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baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with intervention
大体时间：6 month and 12 month for intervention patients only
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6 month and 12 month for intervention patients only
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CAHPS Overall Rating
大体时间：baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with overall care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Cultural Competency
大体时间：baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with cultural competency of care at health center
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baseline, 6 month, and 12 month for intervention patients only
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CAHPS Provider Communication
大体时间：baseline, 6 month, and 12 month for intervention patients only
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Patient satisfaction with provider communication at health center
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baseline, 6 month, and 12 month for intervention patients only
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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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Patient engagement
大体时间：through study completion, an average of 2 years
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Attendance/participation in group visits, text messaging, and booster sessions
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through study completion, an average of 2 years
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Health center provider/staff preparedness
大体时间：change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Capacity, confidence, motivation, perceived benefits and barriers
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change from pre- to post-training (from baseline to 1 month, 7 month, and 16 month)
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Health center provider/staff satisfaction
大体时间：post-training (16 month)
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Satisfaction with training, group visits, and text messaging
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post-training (16 month)
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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：Arshiya Baig, MD, MPH、University of Chicago
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)
2018年10月18日
初级完成 (实际的)
2022年5月15日
研究完成 (实际的)
2022年6月30日
研究注册日期
首次提交
2018年3月21日
首先提交符合 QC 标准的
2018年3月27日
首次发布 (实际的)
2018年4月4日
研究记录更新
最后更新发布 (实际的)
2022年11月3日
上次提交的符合 QC 标准的更新
2022年11月1日
最后验证
2022年11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.
Diabetes MESSAGES Program的临床试验
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Leiden University Medical CenterUMC Utrecht邀请报名
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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Helse Nord-Trøndelag HFNorwegian University of Science and Technology完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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The University of Hong KongSydney Children's Hospitals Network; SAHK完全的