Empowerment and Support for the Diabetic Patient

Type 2 Diabetes Clinical Trial

— CHANGE-D  

Official title:

Coaching for Health to Achieve New Goals in Empowerment for Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02179385
• Other study ID #: 0130-13-COM
• Status: Active, not recruiting
• Phase: N/A
• First received: June 25, 2014
• Last updated: August 4, 2015
• Start date: June 2014

Study information

• Verified date: August 2015
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Health Coaching

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No