Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatment health coaching
Sponsor Clalit Health Services
Collaborator MSD Israel
Start date June 2014
End date June 2016
Trial size 300 participants
Trial identifier NCT02179385, 0130-13-COM

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Patients receive health coaching via the phone, face to face or group support, according to patients' choice
health coaching
(Placebo Comparator)

Primary Outcomes

Measure
Clinical composite
time frame: 0, 6, 12, 18 months from randomization

Secondary Outcomes

Measure
Change in Self Treatment Score
time frame: 0, 6, 12, 18 months from randomization
Change in Self Efficacy Score
time frame: 0, 6, 12, 18 months from randomization

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

Official title Coaching for Health to Achieve New Goals in Empowerment for Diabetes
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Clalit Health Services.