Fusing Rapid-cycle Testing and Adaptive Trial Designs: A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Total Diabetes Distress (T1-DDS Total Score)
研究概览
简要总结
This study is designed to test the feasibility and acceptability of behavioral approaches to reduce diabetes distress ("the expected burdens, concerns, fears, and threats that arise from the challenges of living with diabetes") in adults with type 1 diabetes. This is a pilot study, which will enroll a small group of participants to enroll and give feedback on their experience.
At the study baseline, participants will be randomized to take part in one of two virtual, group-based interventions (the "Primary" intervention) utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress. After the intervention, participants will attend focus groups and fill out anonymous qualitative surveys to give feedback on their experience. Results of the pilot will inform and improve an upcoming research study of the same design.
详细描述
The study will test the feasibility and acceptability of two behavioral-based interventions to reduce diabetes distress (DD). The investigators will enroll one cohort (N=15) adults 30 years and older with type 1 diabetes (T1D) and elevated DD from a single clinical site to participate in a 5-week intervention. All interventions and assessments will be delivered in a pragmatic and entirely virtual format.
The investigators will compare two evidence-based, virtual group interventions to reduce DD in adults with T1D. The study includes a randomization to one of two 5-week Primary Interventions: "ReCharge", an Acceptance and Commitment Therapy (ACT)-focused approach that will help to reduce the emotional burden of diabetes management; or "TakeCharge", a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes.
After the 5-week intervention period, participants will provide final outcome data and feedback on their experience using surveys and focus groups. Quantitative and quantitative results will be used to improve the intervention prior to rollout of a longer-term trial of the same design. Long-term data will be collected at 12-weeks post enrollment.
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 (Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 30 years and older
- •Type 1 diabetes OR latent autoimmune diabetes in adults (LADA) clinically managed as type 1 diabetes
- •Elevated diabetes distress, defined as a score >= 2.0 on the T1-DDAS core scale
- •English speaking
排除标准
- •Does not receive diabetes care at UNC Endocrinology at Eastowne
- •Cannot commit to the pre-scheduled weekly, virtual sessions
- •Diagnosis of any major medical or psychiatric condition that would preclude participation
- •Diagnosis of dementia or other conditions that affect memory or information retention, such as cognitive impairment
- •Visual or auditory impairment that would interfere with participation in a group intervention
- •Receiving inpatient psychiatric treatment or history of a suicide attempt within the past 12 months at the time of enrollment
结局指标
主要结局
Change in Total Diabetes Distress (T1-DDS Total Score)
时间窗: Baseline, Endpoint (6 weeks)
Self-reported total diabetes distress will be measured using the 28-item Type 1 Diabetes Distress Scale (T1-DDS Total Score). The scale yields an overall distress score that is the average of all responses rated on a 6-point Likert scale for all 28 items (range 1-6). A score \>= 2.0 is considered clinically significant diabetes distress. The primary efficacy outcomes of this study is the change in the T1D-DDS score and the proportion of individuals with a change in the T1D-DDS score at least as large as one minimally clinically important difference (MCID).
次要结局
- Change in Core Diabetes Distress (T1-DDAS Core Score)(Baseline, Endpoint (6 weeks))
- Change in Sources of Diabetes Distress (T1-DDS Subscale Scores)(Baseline, Endpoint (6 weeks))
- Change in Perceived Stress(Baseline, Endpoint (6 weeks))
- Change in Diabetes Quality of Life(Baseline, Endpoint (6 weeks))
- Change in Perceived Confidence in Diabetes(Baseline, Endpoint (6 weeks))
- Change in Diabetes Specific Self-Compassion(Baseline, Endpoint (6 weeks))
- Change in Hypoglycemic Attitudes and Behaviors(Baseline, Endpoint (6 weeks))
- Change in Hemoglobin A1c (HbA1c)(Baseline, Endpoint (6 weeks))
- Change in Percent of Time in Range (TIR)(Baseline, Endpoint (6 weeks))
- Change in Percent of Time Below Range (TBR)(Baseline, Endpoint (6 weeks))
- Change in Percent of Time Above Range (TAR)(Baseline, Endpoint (6 weeks))
- Glycemic Variability(Baseline, Endpoint (6 weeks))