The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities
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|ClinicalTrials.gov Identifier: NCT02861144|
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Other: Ma ka hana ka ̒ike Other: Hanapū Provider Toolbox||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Partnerships for Cardiometabolic Disparities in Native and Pacific People|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||November 2013|
Patient participants in the intervention arm will receive diabetes self-management program, Ma ka hana ka ̒ike which includes 5 interactive group sessions lasting 1-1/2 hours in length delivered by community peer educators once a month for 4.5 months. After 4.5 months, the patient will receive 4 monthly boosters by mail that will reinforce information from the Ma ka hana ka ̒ike program. Completion of diabetes process and glycemic outcomes will trigger the modest financial incentives.
Health care provider participants in the intervention arm will receive educational resources, Hanapū Provider Toolbox to guide their patients to optimal glycemic control.They will receive modest financial incentives when their patients complete clinical tests and achieve glycemic target.
Other: Ma ka hana ka ̒ike
Ma ka hana ka ̒ike is a self-management program for diabetic patients which includes 5 interactive group sessions lasting 1-1/2 hours in length delivered by community peer educators once a month for 6 months.
Other: Hanapū Provider Toolbox
Hanapū Provider Toolbox is an educational tools that will aid the health care providers in guiding their patients to optimal glycemic control.
No Intervention: Usual Care
Patient participants in the usual care arm will receive 5 mail-out diabetes self management education booklets endorsed by the American Diabetes Association (ADA) and the National Institute for Diabetes, Digestive and Kidney disease for 4.5 months. Patients will see their doctor according to usual care practice. After 4.5 months, the patients will receive 4 monthly boosters in mail reinforcing the previous mail-out diabetes self-management program materials.
Health care provider participants in the usual care arm will receive the latest ADA guidelines to use in their treatment plan of their patients.
- Change of HbA1c [ Time Frame: Baseline, 4.5 months and 9 months ]HbA1c assessment will be done at baseline and during the intervention follow up periods (4.5 and 9 months) to see incremental improvement (0.5% decrease in HbA1c) or achieving optimal control (HbA1c < 7%).
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): NCT02861144
|Principal Investigator:||Marjorie K Mau, MD||The University of Hawaii|