ACT1VATE: Addressing Emotional Distress to Improve Outcomes Among Diverse Adults With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Glycosylated Hemoglobin (HbA1c)
研究概览
简要总结
This research will compare a psychological intervention ("ACT1VATE") versus diabetes self-management education and support (DSME/S; usual care) in improving clinical, behavioral, psychosocial, process, and cost outcomes among adults with poorly controlled type 1 diabetes (T1D) who are experiencing significant diabetes-related emotional distress and poor glycemic control in a real world, healthcare environment.
详细描述
This randomized controlled trial will compare a telemedicine psychological intervention specifically designed to address diabetes distress ("ACT1VATE") versus traditional diabetes self-management education and support (DSME/S; usual care) in improving glycemic control among N=250 adults with type 1 diabetes (T1D), glycosylated hemoglobin (HbA1c) between 7.0% - 12.5% in the last 90 days, and significant diabetes distress. Capitalizing on existing and real-world processes, the electronic health record (EHR) will be used to identify eligible patients and examine primary outcomes. Participants randomized to the usual care group will be offered standard, 1:1 DSME/S delivered by a Certified Diabetes Care and Education Specialist via telemedicine format. Participants randomized to the ACT1VATE group will be offered 5 group-therapy telemedicine sessions delivered by a Behavioral Health Provider who is an integrated member of the diabetes care team. ACT1VATE is grounded in Acceptance and Commitment Therapy (ACT), which has been delivered effectively in clinics via brief format; implemented via phone and other modalities; and adapted for a wide range of chronic conditions. The primary clinical outcome, HbA1c, assessed as part of quarterly standard-of-care medical visits will be extracted from the EHR over 12 months. Changes in patient-reported behavioral (diabetes self-care) and psychosocial (emotional well-being, quality of life) outcomes will be evaluated via online surveys at baseline, month 6, and month 12. A thorough process evaluation will be conducted to establish reach, acceptability/feasibility, adoption/maintenance, and fidelity of the intervention and will integrate patient and provider perspectives. Cost-effectiveness will also be examined from the health system perspective. By maximizing integration with routine medical care for T1D in a real world, healthcare environment, results will be highly generalizable and hold great potential to inform the future of care for adults living with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spanish or English-speaking
- •Type 1 diabetes
- •Glycosylated Hemoglobin (HbA1c) 7.0% - 12.5% in last 90 days
- •Screen positive for diabetes distress
排除标准
- •Severe medical or psychological conditions that would interfere with participation based on the opinion of a provider
- •Plans to move out of the San Diego area in the next 12 months
- •Lack of technology capability required to complete online surveys and telemedicine visit
研究组 & 干预措施
ACT1VATE
Participants assigned to the intervention group will be offered a psychological intervention specifically designed to address diabetes-related emotional distress.
干预措施: ACT1VATE (Behavioral)
DSME/S (usual care)
Participants randomized to the usual care group will be offered standard diabetes self-management education and support (DSME/S).
干预措施: DSME/S (Behavioral)
结局指标
主要结局
Glycosylated Hemoglobin (HbA1c)
时间窗: Baseline, 3 months, 6 months, 9 months, 12 months
HbA1c (%) reflects average glucose over the past 2-3 months, with higher values indicating greater risk for developing diabetes-related complications. HbA1c for up to 5 data points (0, 3, 6, 9, 12 months) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine HbA1c changes. Analyses will include the between-subjects factor of group and the within-subjects factor of time. Month 0 will be the referent time-point with post-intervention and follow-up time-points as comparison time-points in dummy-coded predictors. The group by time interaction is of primary interest. If an interaction is found significant, follow-up analyses will determine the nature of differential change between treatment conditions.
Diabetes Distress Scale
时间窗: Baseline, 6 months, 12 months
The Type 1 Diabetes Distress Scale (T1-DDS; 28 items averaged to obtain a total score ranging 1-6, with higher scores indicating greater diabetes-related emotional stress) will be analyzed. Multilevel models using full information maximum likelihood estimation will be conducted to examine change in diabetes distress over time. Analyses will include the between-subjects factor of group and the within-subjects factor of time. Month 0 will be the referent time-point with post-intervention and follow-up time-points as comparison time-points in dummy-coded predictors. The group by time interaction is of primary interest. If an interaction is found significant, follow-up analyses will determine the nature of differential change between treatment conditions.
次要结局
- Patient Health Questionnaire-8(Baseline, 6 months, 12 months)
- Summary of Diabetes Self-Care Activities Survey(Baseline, 6 months, 12 months)
- The WHO Well-Being Index(Baseline, 6 months, 12 months)
- Hypoglycemic Attitudes and Behaviors Scale(Baseline, 6 months, 12 months)
- Generalized Anxiety Disorder Assessment(Baseline, 6 months, 12 months)
- Revised Diabetes Knowledge Test(Baseline, 6 months, 12 months)
- Perceived Stress Scale(Baseline, 6 months, 12 months)
- Diabetes Support and Isolation Questionnaire(Baseline, 6 months, 12 months)
研究者
Athena Philis-Tsimikas
Corporate Vice President
Scripps Whittier Diabetes Institute