The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities

NCT02861144 | Completed DMC

• 2 other identifiers: CHS#185393P20MD000173-09S1
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

OTHER

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; Other: Hanapū Provider Toolbox

Usual Care

NO INTERVENTION

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.

Interventions

Ma ka hana ka ̒ike 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.

Intervention

Hanapū Provider Toolbox OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Hawaii: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marjorie K Mau, MD

  The University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2016
• First Posted: August 10, 2016
• Study Start: February 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 11, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share