Improving Self-Regulation and Social Support for Type 1 Diabetes During Emerging Adulthood (FAMS-T1D)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- Change in HbA1c (Person with Diabetes)
研究概览
简要总结
The goal of this clinical trial is to evaluate how effective the FAMS-T1D intervention is for improving self-regulation (e.g., setting and meeting goals for type 1 diabetes) and social support for meeting those goals for young adults. The main questions that are examined include 1) whether the intervention improves blood glucose, self-management and diabetes distress across time, 2) whether these improvements occur through better self-regulation and social-regulation, 3) whether the intervention improves outcomes for support persons (a friend or family member invited to participate by the person with diabetes) without increasing support burden and 4) whether the intervention improves for persons with diabetes who are on continuous blood glucose monitor their time in range.
详细描述
This 12-month intervention is an adaptation and expansion of an intervention originally developed for adults with type 2 diabetes (FAMS; NCT02481596) for young adults with type 1 diabetes. FAMS-T1D includes multiple components:
- Monthly coaching sessions (20-30 minutes each) with young adults with type 1 diabetes by phone. The coaching focuses on how to set specific and achievable diabetes goals and to increase helpful and decrease unhelpful family and friend behaviors related to those goals.
- Daily text messages to the person with diabetes to support meeting diabetes goals and engage support that is helpful in meeting those goals.
- Weekly text messages where the person with diabetes responds to how well they have met their goals followed by personalized feedback from the coach.
- The option to invite an adult support person to also receive text messages that assist the support person in providing support that assists the person with diabetes in meeting their goals set in the coaching sessions.
Participants will be randomized to either the intervention or an active control where individuals receive materials relevant to their type 1 diabetes. We plan to enroll 280 persons with diabetes and support persons (optional for persons with diabetes). Persons with type 1 diabetes and their support person (when enrolled) will be randomized together. The study is powered to detect a .5% reduction in hemoglobin A1c. Analyses will examine effects at 6 months (post intervention) and at 12 months (maintenance of effects). The investigators will impute missing data and individuals will be analyzed as randomized irrespective of whether they withdraw or remain in the study following intention-to-treat principals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigators use mail-in A1c kits for the primary outcome-hemoglobin A1c-and the lab analyzing these samples is masked to participants' assigned condition.
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PERSONS WITH DIABETES
- •Ages 18-24
- •Have a diagnosis of T1D and has been taking insulin for at least one year
- •Comfortable sending texts
- •Can speak, read, and write in English
- •Meets one of the following two criteria: 1) has a most recent A1c value in of 7.5% or higher (prioritizing EHR, next self-report) or missing in EHR) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2).
- •SUPPORT PERSON
- •Can speak, read, and write in either English or Spanish
- •Comfortable sending and receiving texts
- •Ages 18 and older
排除标准
- •PERSONS WITH DIABETES:
- •Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
- •Plans to live outside of the country during study period.
- •SUPPORT PERSON
- •Shares a phone with the patient participant.
- •Plans to live outside of the country during study period.
结局指标
主要结局
Change in HbA1c (Person with Diabetes)
时间窗: Baseline and 6, 9, and 12 months post baseline
Higher values indicate values more off target. Hemoglobin A1C assessed by mail-in kits from University of Minnesota ARDL
Change in Self-Management (Person with Diabetes)
时间窗: Baseline and 6, 9, and 12 months post baseline
Self-care inventory revised, higher values indicate better self-management (values range from 1 to 5)
次要结局
- Diabetes Distress (Person with Diabetes)(Baseline and 6, 9, and 12 months post baseline)
研究者
Cynthia Berg
Distinguished Professor
University of Utah