Reducing Distress And Improving Glycemic Control In Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Diabetes Distress
研究概览
简要总结
Diabetes Distress (DD) refers to the emotional and behavioral challenges and burdens that arise through living with and managing diabetes. High DD is characterized by feeling frustrated, overwhelmed and discouraged by the demands of diabetes, and high DD may have a negative impact on disease management and glycemic control; poor glycemic control can also have a negative effect on DD.
Few interventions have been assessed that directly target DD or mood in adults with Type 1 diabetes. In this study the investigators will compare two active, evidence-based behavioral interventions to reduce high DD and improve glycemic control and disease management:
- A Type 1 diabetes education protocol ('KnowIt') that brings together new advances in diabetes education and behavioral management.
- A DD-reduction protocol ('OnTrack') that helps identify and address the personal stresses and strains of having diabetes.
Participants in both arms will attend a single, day-long workshop, four hour-long web group meetings and four personal phone calls with the group facilitator during the intervention period. Assessments will be carried out at baseline and at three and nine months.
Hypothesis 1: OnTrack will be superior to KnowIt in the primary and secondary outcomes at follow-up.
Hypothesis 2: Changes in self-efficacy and fear of hypoglycemia over time will mediate the difference between the two study arms and primary outcome.
Hypothesis 3: The differences between the two study arms and changes in the primary outcomes will be qualified by patient characteristics such as age, length of diagnosis, higher baseline distress or HbA1c.
详细描述
A behavioral randomized control trial (RCT) for high diabetes distress. In Phase 2 we propose a practical two-arm, nine month RCT to reduce high DD and improve glycemic control and disease management. We will compare two active interventions: (1) a Type 1 diabetes education protocol ('KnowIt') that brings together new advances in diabetes education and behavioral management, and (2) A DD-reduction protocol ('OnTrack') that helps identify and address the personal stresses and strains of having diabetes.
Patients in both study arms will receive three months of intervention and six months of follow-up. Each arm includes a one-day in-person group workshop for 8-10 participants; four real-time, 65-minute web-based group meetings; and six individual telephone calls from the group leader. The web-based meetings will occur at two, four, eight and 12 weeks after the workshop. Four of the personal phone calls will occur one week prior to each web-based group meeting to provide support and encourage participation in the group meetings; two personal phone calls will occur at weeks 20 and 28 (between months thee and nine) to maintain support and participation. Assessment will take place at baseline, 12 and 36 weeks from the initial workshop.
Hypotheses:
H1. The OnTrack arm will be superior to KnowIt on the primary outcomes (HbA1c and DD) and the secondary outcomes (diabetes management) at 12 and 36 weeks.
H2. (mediator hypothesis). Differential between-group change in primary outcomes will be mediated by changes in self-efficacy and fear of hypoglycemia across time.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 or older
- •Type 1 diabetes
- •Diagnosed at least 12 months
- •Intensive insulin use
- •Recent HbA1c result of 7.5 or higher
- •At least moderate diabetes distress (score 2.0 or higher on T1 Diabetes Distress scale)
- •Able to speak/read English fluently
排除标准
- •Severe complications or disorders (e.g. heart attack in past 12 months, psychosis, blindness, end-stage dialysis).
研究组 & 干预措施
KnowIt
Please see the 'KnowIt' intervention description below. Diabetes education, behavioral management
干预措施: 'KnowIt' (Behavioral)
OnTrack
Please see the 'OnTrack' intervention description below. Diabetes Distress Reduction, Problem Solving Therapy
干预措施: 'OnTrack' (Behavioral)
结局指标
主要结局
Diabetes Distress
时间窗: Baseline to 9 months
Distress across several domains will be assessed using the Type 1 Diabetes Distress Scale.
HbA1c
时间窗: Baseline to 9 months
Assay
次要结局
- Self-efficacy(Baseline to 9 months)
- Hypoglycemia confidence(Baseline to 9 months)
- Depression(Baseline to 9 months)