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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health coaching | Experimental | Patients receive health coaching via the phone, face to face or group support, according to patients' choice |
|
| Standard of Care | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Coaching | Behavioral |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of life score | Change from baseline in Diabetes Quality of Life questionnaire score at 12 months from randomization | 0, 12 months from randomization |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Change from baseline in Self Efficacy questionnaire score at 6, 12 and 18 months from randomization
| 0, 6, 12, 18 months from randomization |
| D004700 | Endocrine System Diseases |