Coaching for Health to Achieve New Goals in Empowerment for Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Clalit Health Services
- Enrollment
- 300
- Primary Endpoint
- Clinical composite
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Margalit (Margita) Goldfracht
Department Manager of Quality Promotion, Community Medical Division
Clalit Health Services
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Type 1 diabetes
- •Pregnancy or lactation
- •Incompetency to sign consent
- •Participation in another clinical trial
- •Unstable psychotic disease
- •Complex health condition
Outcomes
Primary Outcomes
Clinical composite
Time Frame: 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
Secondary Outcomes
- Change in Self Treatment Score(0, 6, 12, 18 months from randomization)
- Change in Self Efficacy Score(0, 6, 12, 18 months from randomization)