Improving Diabetes Outcomes and Health Disparities Through a Patient Activation Intervention Addressing Unmet Resource Needs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 667
- 试验地点
- 2
- 主要终点
- Change in HbA1c as Measured by an HbA1c Machine
研究概览
简要总结
This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18-75 years of age
- •Be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication
- •Have a most recent hemoglobin A1c(HbA1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and >8.0% for individuals between 70-75 years in age
- •Have access to a telephone that can receive and send text messages
- •Not participating in another diabetes intervention research study
排除标准
- •Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.
结局指标
主要结局
Change in HbA1c as Measured by an HbA1c Machine
时间窗: Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported)
HbA1c will be measured at baseline, 6 months, and 12 months using HbA1c machine. HbA1c is a measure of the average level of glucose in blood over the past 3 months measured as a percentage. The change in HbA1c from baseline to 12 months is reported here as the primary outcome.
次要结局
- Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire(Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported))
- Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine(Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported))
- Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire(Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported))
- Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire(Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported))
- Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT)(Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported))
- Change in Unmet Social Risk Factors as Measured by Participant Questionnaire(Assessed at Baseline, 6 months, 12 months (Change between baseline and 12 months reported))
研究者
Minal Patel
Associate Professor
University of Michigan