The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities

Not Applicable

Completed

• Conditions: Diabetes

• Registration Number: NCT02861144
• Lead Sponsor: University of Hawaii

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2016-08
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-05
• Last Update Submitted: 2016-08-09
• Study First Posted: 2016-08-10
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of HbA1c	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%).