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Completed

NCT Number: NCT02861144

The Hanapū Study: Incentivized Partnerships to Reduce Diabetes Disparities

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Change of HbA1c

    Time frame: 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%).

Sponsors and collaborators

Lead sponsor

University of Hawaii

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Partnerships for Cardiometabolic Disparities in Native and Pacific People

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 10, 2016
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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