Testing New Models of Diabetes Self-Management to Improve Population Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
研究概览
简要总结
Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.
Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.
These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.
详细描述
A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes mellitus (T2DM) - self-reported diagnosis by a health care provider
- •HbA1c value greater than or equal to 7.5%
- •Adults ages 25 years and older
- •All genders
- •Have access to device (smartphone/tablet which meets iOS 13 or above or similar system requirements/iPhone 7 and above or Android 6 and above) and internet in order to view online diabetes education content
- •Ability to read and speak English
- •Resides in Texas
排除标准
- •Pregnant women
- •Participation in ADA-recognized or AADE-accredited diabetes self-management education program lasting at least eight hours within previous six months
- •Engagement with ADA-recognized or AADE-accredited smartphone application with certified diabetes educators providing tracking and health coaching within the previous six months
- •Those diagnosed with any conditions listed below (determined by self-report): Liver failure, End-stage renal disease (stage 4 or 5), Congestive heart failure (grade C or D), Organ transplant or bone marrow transplant, Cystic fibrosis, Malignant neoplasm or bone marrow transplant
- •Criteria excludes individuals based on language. Participants must be able to read and speak English. Technology-based education and support (TBES) is available only in English.
研究组 & 干预措施
Virtual Making Moves with Diabetes [MMWD] Group
Virtual asynchronous training and periodic one-on-one counseling with a clinical diabetes educator, either a Registered Nurse (RN) or Registered Dietitian Nutritionist (RDN). The program was recognized by the American Diabetes Association during this study. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, and 3 and 6-month follow-ups.
干预措施: Living Healthier with Diabetes (Behavioral)
App Group
Smartphone application for more continuous but less structured chat support. This app was recognized by the American Diabetes Association. The intervention included access to online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
干预措施: Living Healthier with Diabetes (Behavioral)
Combo Group
A combined approach for maximal support and reinforcement. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, access to the app with online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.
干预措施: Living Healthier with Diabetes (Behavioral)
结局指标
主要结局
A1C -Change in HbA1c between baseline, 3 months, and 6 months is the primary outcome.
时间窗: 12 months
A1C values will be treated continuously in analyses, with possible values ranging from 4 to 14 due to instrument precision at the higher values.
次要结局
- Diabetes Knowledge: Knowledge of diabetes will be measured by the simplified version of the Revised Diabetes Knowledge Scale (True/False version).(12 months)
- Diabetes Care Confidence(12 months)
- A1C(12 months)
- Diabetes Self Care(12 months)
- Diabetes care distress(12 months)
研究者
Marcia G Ory
Regents and Distinguished Professor
Texas A&M University