Empowerment and Support for the Diabetic Patient

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Health Coaching

• Registration Number: NCT02179385
• Lead Sponsor: Clalit Health Services

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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-30
• Study First Posted: 2014-07-01
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-04
• Last Update Posted: 2015-08-06
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health coaching	Health Coaching	Patients receive health coaching via the phone, face to face or group support, according to patients' choice

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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