Journey for Control of Diabetes Study (0431-111)
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|ClinicalTrials.gov Identifier: NCT00652509|
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Interactive Dialogue to Educate and Activate (IDEA) Behavioral: Individual Education (IE)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||621 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Journey for Control of Diabetes Study|
|Actual Study Start Date :||May 1, 2008|
|Actual Primary Completion Date :||March 1, 2010|
|Actual Study Completion Date :||July 1, 2011|
Behavioral: Interactive Dialogue to Educate and Activate (IDEA)
IDEA - patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients.
Active Comparator: 2
Behavioral: Individual Education (IE)
IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.
No Intervention: 3
UC: Patients receive no research intervention.
- Program satisfaction, behavioral and emotional outcomes. [ Time Frame: 3, 6, 9, 12 months after implementation of intervention ]
- Blood sugar level, blood pressure, lipids, cost, comorbidities. [ Time Frame: 6, 12, 18, 24, 36, and 48 months after intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652509
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|