Promoting Adolescent Investment In Diabetes Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.
详细描述
Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>12 and ≤18 years old
- •Diagnosed with type 1 diabetes ≥12 months
- •Speaks English fluently
- •Cognitively able to participate in incentive program and complete surveys.
- •Have access to a mobile phone to receive goal-obtainment and incentive updates
- •Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic
- •Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics
排除标准
- •Patient is already participating in another research study to improve diabetes self-care and/or glycemic control
- •Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen)
- •Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age
- •Cognitively or physically unable to participate
- •Patient is unable to speak in the English language
- •Patient is unable to read in the English language
- •Patient is a ward of the state
- •Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
结局指标
主要结局
HbA1c
时间窗: 12 weeks
Change in HbA1c from baseline to 12 weeks
次要结局
- Time in Range(12 weeks)
- Insulin Administration(12 weeks)
- PAID-T(12 weeks)
- DFCS(12 weeks)
- Glucose monitoring(12 weeks)
- SCI-R(12 weeks)
研究者
Davene R. Wright
Faculty
Harvard Pilgrim Health Care