The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities

NCT ID: NCT02861144

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-11-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: OTHER

Ma ka hana ka ̒ike

Intervention Type: OTHER

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.

Hanapū Provider Toolbox

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Hawaii

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjorie K Mau, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hawaii

Other Identifiers

3P20MD000173-09S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHS#18539

Identifier Type: -

Identifier Source: org_study_id