Discovery Diabetes: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in Glycemic Control (HbA1c)
研究概览
简要总结
The goal of this clinical trial is to learn if the Discovery Program can help improve diabetes management in adolescents and young adults with type 1 diabetes (T1D). The main questions it aims to answer are:
Does the Discovery Program lead to better glycemic control as measured by HbA1c levels? How does participation in the Discovery Program affect diabetes distress and self-management skills? Researchers will compare participants in the Discovery Program to those receiving standard diabetes care to see if the program has a positive effect on diabetes management.
Participants will:
Engage in a 3-month intervention that includes personalized mobile health communications and clinician support.
Complete surveys and assessments at the beginning of the study, and again at 3 and 6 months.
Allow the study team to access their electronic health records for additional data on diabetes management.
详细描述
The Discovery Diabetes study is a pilot randomized controlled trial designed to evaluate the effectiveness of the Discovery Program in improving diabetes management among adolescents and young adults with type 1 diabetes (T1D). This study focuses on participants aged 13 to 21 who have been diagnosed with T1D for at least one year.
Study Design: Participants will be randomly assigned to either the intervention group, which will receive the Discovery Program, or a control group receiving standard diabetes care. The Discovery Program includes personalized mobile health communications, clinician support, and structured problem-solving sessions aimed at addressing psychosocial barriers to effective diabetes management.
Objectives: The primary objective is to determine whether the Discovery Program leads to significant improvements in glycemic control, measured by changes in HbA1c levels over a 6-month period. Secondary objectives include assessing the impact on diabetes distress, self-management behaviors, and participants' problem-solving skills.
Data Collection: Data will be collected at baseline, 3 months, and 6 months, utilizing a variety of methods, including surveys and electronic health records (EHR). The study will ensure participant confidentiality through the use of unique study IDs and secure, HIPAA-compliant data storage systems, such as REDCap.
Eligibility Criteria: Eligible participants include those aged 13-21 with a diagnosis of type 1 diabetes, while individuals with type 2 diabetes or other conditions that may hinder participation will be excluded.
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
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents (13-17 years) and young adults (aged 18-21 years),
- •Diagnosed with T1D for at least one year,
- •Access to a smartphone,
- •A My Health at Vanderbilt (MHAV) patient portal account,
- •Ability to read, speak, and understand English,
- •An appointment with an NP in the VUMC Eskind Clinic within 7 months of initial contact
排除标准
- •Diagnosis of type 2 diabetes
- •Any physical, cognitive, sensory or emotional condition precluding participation in the intervention (seeing/using a phone, hearing digital stories, answering questions).
结局指标
主要结局
Change in Glycemic Control (HbA1c)
时间窗: Baseline, 3 months, 6 months, and 9 months
This outcome measure will assess the change in glycemic control among participants, as indicated by changes in HbA1c levels. The primary aim is to determine whether the Discovery Program leads to significant improvements in glycemic control compared to standard diabetes care.
次要结局
- Change in Diabetes Distress (PAID-T)(Baseline, 3 months, and 6 months)
- Change in Self-Management Barriers (BDA)(Baseline, 3 months, and 6 months.)
- Change in Diabetes Self-Management Efficacy (SCI-R)(Baseline, 3 months, and 6 months.)
- Change in Glycemic Control (Time in Range)(Baseline, 3 months, 6 months, and 9 months)
- Change in Diabetes Distress (PAID-T)(Baseline, 3 months, and 6 months)
- Change in Self-Management Barriers (BDA)(Baseline, 3 months, and 6 months.)
- Change in Problem-Solving Skills (SPSI-R:SF)(Baseline, 3 months, and 6 months.)
- Change in Diabetes Self-Management Efficacy (SCI-R)(Baseline, 3 months, and 6 months.)
- Change in Glycemic Control (Time in Range)(Baseline, 3 months, 6 months, and 9 months)
研究者
Shelagh Mulvaney
Principal Investigator
Vanderbilt University