Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes, Type II diabetes
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
Interventions
BEHAVIORALHealth Coaching
Sponsors
Merck Sharp & Dohme LLC
Clalit Health Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical composite | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Self Treatment Score | 0, 6, 12, 18 months from randomization | Change from baseline in Self treatment diabetes questionnaire score at 6, 12 and 18 months from randomization |
| Change in Self Efficacy Score | 0, 6, 12, 18 months from randomization | Change from baseline in Self Efficacy questionnaire score at 6, 12 and 18 months from randomization |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of life score | 0, 12 months from randomization | Change from baseline in Diabetes Quality of Life questionnaire score at 12 months from randomization |
Outcome results
None listed