A Pilot Trial of an Intervention to Support Initial Type 2 Diabetes Self-management Among Younger Adults With Children (STRIDE)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Diabetes Distress Scale (DDS)
研究概览
简要总结
This study will test STRIDE (SupporTing paRents with DiabEtes), a virtually delivered program that helps adults ages 21-44 who were recently diagnosed with type 2 diabetes and are caring for a child ages 2-14 within Kaiser Permanente Northern California. STRIDE focuses on practical skills for everyday life, with sessions on Prioritizing Self-Care, Eating Well Together, and Getting Active as a Family.
详细描述
To date, most tailored programs have focused only on cultural tailoring (based on race and ethnicity) and not on a patient's life stage. To address this gap, we developed a self-management support program, STRIDE (SupporTing paRents with DiabEtes), designed for adults with type 2 diabetes who are raising children.
This study will evaluate the STRIDE program in a randomized pilot design to understand how well it meets the needs of younger adults with type 2 diabetes who are raising children. The study will examine whether STRIDE helps participants build early self management skills and reduces challenges that can interfere with diabetes care. Findings from this pilot will provide information needed to refine the program and guide future implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kaiser Permanente Northern California members newly diagnosed with T2D (within the past 5 years)
- •Proficient in English
- •Primary caregivers to ≥1 child (ages 2-14 years at time of enrollment)
- •Can receive text messages
- •Able to participate in a virtual session
排除标准
- •Pregnant women
- •Type 1 Diabetes
- •Unable to receive text messages
- •Unable to participate in a virtual session
研究组 & 干预措施
Usual Care
This arm will continue to receive their usual diabetes care. After completing 6-month outcome assessments, they will be offered an opportunity to participate in the STRIDE program
Experimental: STRIDE Program
Participants enrolled in the STRIDE arm will be invited to attend the live and recorded sessions let by a clinician and receive 24 tailored text messages, in addition to their usual diabetes care.
干预措施: STRIDE Program (Behavioral)
结局指标
主要结局
Diabetes Distress Scale (DDS)
时间窗: Baseline and 4-5 months following enrollment
Diabetes Distress Scale (DDS), a validated 17-item scale covering 4 domains: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress. Each item is rated on a 6-point scale (1 = not a problem to 6 = a very serious problem), with higher scores indicating greater diabetes-related distress (worse outcome).
Diabetes Self-Efficacy
时间窗: Baseline and 4-5 months following enrollment
The Diabetes Self-Efficacy Scale is a validated 8-item measure that assesses an individual's confidence in performing diabetes self-care activities. Items are rated on a 10-point scale (1 = not at all confident to 10 = very confident), with higher scores indicating greater self-efficacy.
Diabetes Distress Scale (DDS)
时间窗: 6-Months Following Enrollment
Diabetes Distress Scale (DDS), a validated 17-item scale covering 4 domains: emotional burden, physician-related distress, regimen-related distress, and interpersonal distress.
Diabetes Self-Efficacy
时间窗: 6-Months Following Enrollment
Outcome will be assessed using Diabetes Self-Efficacy Scale survey (baseline and 6 month).
次要结局
- Report of Children's Health-Related Behaviors(Baseline and 4-5 months following enrollment)
- HbA1c at 6 Months(6-Months Following Enrollment)
- Completion of HbA1c Monitoring(6-Months Following Enrollment)
- T2D-related care(6-Months Following Enrollment)
- Medication Use(6-Months Following Enrollment)
- Self-Reported T2D Self-Management(6-Months Following Enrollment)
- Report of Children's Health-Related Behaviors(6-Months Following Enrollment)