Coaching for Health to Achieve New Goals in Empowerment for Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Clinical composite
研究概览
简要总结
CHANGE-D objectives are to evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves clinical outcomes among uncontrolled diabetic patients.
Evaluate to what extent personal coaching for healthy lifestyle and treatment adherence improves self treatment among uncontrolled diabetic patients.
详细描述
Research Group 300 type 2 diabetics: 150 from Jewish sector and 150 from Arab sector will be recruited from 7-10 clinics in each district: North District and Haifa District A personal coaching intervention will be tailored from the offered tools: Face to face, group, telephone Participants will be monitored for clinical and self treatments outcomes Comparison Group 300 patients with similar characteristics to the research group will receive Clalit's standard of care Participants will be monitored for clinical and self treatments outcomes like the research group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •At least one oral anti diabetic drug
- •HbA1c above 7.5% ot above 0.5% of personal target
- •Preparedness for change
- •Fluent Hebrew or Arabic
排除标准
- •Type 1 diabetes
- •Pregnancy or lactation
- •Incompetency to sign consent
- •Participation in another clinical trial
- •Unstable psychotic disease
- •Complex health condition
研究组 & 干预措施
Health coaching
Patients receive health coaching via the phone, face to face or group support, according to patients' choice
干预措施: Health Coaching (Behavioral)
Standard of Care
结局指标
主要结局
Clinical composite
时间窗: 0, 6, 12, 18 months from randomization
Change from baseline in a composite endpoint of HbA1c, BMI, Blood Pressure, Lipids at 6, 12 and 18 months from randomization
次要结局
- Change in Self Treatment Score(0, 6, 12, 18 months from randomization)
- Change in Self Efficacy Score(0, 6, 12, 18 months from randomization)
研究者
Margalit (Margita) Goldfracht
Department Manager of Quality Promotion, Community Medical Division
Clalit Health Services