Empowerment and Support for the Diabetic Patient (CHANGE-D)

Clalit Health Services

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Behavioral: Health Coaching

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02179385

0130-13-COM

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Health coaching

Experimental group

Description:

Patients receive health coaching via the phone, face to face or group support, according to patients' choice

Treatment:

Behavioral: Health Coaching

Standard of Care

Placebo Comparator group