The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities

Study Overview
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Brief Summary
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The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities is a randomized control trial that will test the effectiveness of partnership incentives plus evidence-based education to optimize glycemic outcomes among diabetic patients compared with usual care.

Detailed Description
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The Hanapū Study will use a block randomization study design to enroll 100 diabetic patients in each arm (n = 200) followed over 9 months. Providers will identify diabetic patients. After the baseline visit is completed, patient(s) and their provider will be randomized to either Intervention or Usual care arm as partners. The intervention arm will receive diabetes self-management education and modest financial incentives (gift cards) for completing diabetes process and glycemic outcomes according diabetes best practices. Usual care patients will receive an equal number of educational materials on diabetes self-management via mail and will receive usual care through their provider but will not receive additional incentives for reaching glycemic outcomes. Both arms of the study will complete outcome visits at baseline, 4.5 and 9 months.

Official Title
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Partnerships for Cardiometabolic Disparities in Native and Pacific People

Conditions
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Diabetes

Intervention / Treatment
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* Other: Ma ka hana ka ̒ike
* Other: Hanapū Provider Toolbox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of diabetes mellitus HbA1c >7% Not planning to move out of the State Able to fully participate in either intervention or usual care arms. Exclusion Criteria: Pregnancy End Stage Renal Disease requiring dialysis Any medical condition that would prevent participation in all aspects of the study protocol (including major psychiatric diagnosis) or with < 6 month expected survival, as determined by the patient's physician.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>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<br>* 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.<br>Other: Hanapū Provider Toolbox<br>* Hanapū Provider Toolbox is an educational tools that will aid the health care providers in guiding their patients to optimal glycemic control.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c | 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%). | Baseline, 4.5 months and 9 months |