Empowerment and Support for the Diabetic Patient

Study Overview
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Brief Summary
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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
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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

Official Title
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Coaching for Health to Achieve New Goals in Empowerment for Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Health Coaching


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health coaching<br>Patients receive health coaching via the phone, face to face or group support, according to patients' choice | Behavioral: Health Coaching<br> <br> |
| Placebo Comparator: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical composite | Change from baseline in a composite endpoint of HbA1c, BMI, Blood Pressure, Lipids at 6, 12 and 18 months from randomization | 0, 6, 12, 18 months from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self Treatment Score | Change from baseline in Self treatment diabetes questionnaire score at 6, 12 and 18 months from randomization | 0, 6, 12, 18 months from randomization | 
| Change in Self Efficacy Score | Change from baseline in Self Efficacy questionnaire score at 6, 12 and 18 months from randomization | 0, 6, 12, 18 months from randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Type II diabetes