Electronically Connected Health Coaching in Improving Type 2 Diabetes Self Management - Phase III Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
Patients with Type 2 Diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better Hemoglobin A1c levels at 6 months post-intervention than patients with Type 2 Diabetes allocated to the control arm (health coaching alone).
详细描述
Inclusion criteria: all participating patients have been diagnosed with Type 2 Diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have HbA1c levels > or = to 7.3.
Exclusion criteria: Axis I and II psychiatric disorders.
Primary outcome: HBA1c at 6 months follow up.
Secondary outcome: Centre for Epidemiological Studies Depression Scale
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Type 2 Diabetes
- •Fluency in English and/or Spanish
排除标准
- •> 75 years of age
研究组 & 干预措施
Lifestyle counseling with smartphones
Lifestyle counseling assisted by smartphones
干预措施: Lifestyle counseling with smartphone (Behavioral)
Lifestyle counseling
Lifestyle counseling
干预措施: Lifestyle counseling (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 6 months follow up from baseline
Finger prick A1c test or lab test
次要结局
- Center for Epidemiological Studies Depression Scale(6 months follow up from baseline assessment)
研究者
Paul Ritvo
Associate Professor, School of Kinesiology and Health Science
York University