The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities

Diabetes Clinical Trial

Official title:

Partnerships for Cardiometabolic Disparities in Native and Pacific People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861144
• Other study ID #: CHS#18539
• Secondary ID: 3P20MD000173-09S
• Status: Completed
• Phase: N/A
• First received: August 5, 2016
• Last updated: August 9, 2016
• Start date: February 2011
• Est. completion date: November 2013

Study information

• Verified date: August 2016
• Source: University of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes

Intervention

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.
• Hanapu Provider Toolbox
Hanapu Provider Toolbox is an educational tools that will aid the health care providers in guiding their patients to optimal glycemic control.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Hawaii	National Institute on Minority Health and Health Disparities (NIMHD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No