Diabetes Mellitus Clinical Trial
Official title:
A Randomized Incentive-Based Diabetes Self-Management Study (Hawaii Patient Reward And Incentives to Support Empowerment Project)
The purpose of this randomized controlled trial (RCT) study is to examine the extent that
financial incentives when combined with diabetes evidence-based practices, improve
self-management and biometric measures for adult diabetic Medicaid recipients with an HbA1c
of ≥ 6.5 at enrollment. The study will also evaluate the cost-effectiveness of the program.
Specific Aims:
1. Evaluate whether financial incentives for completing American Diabetes Association (ADA)
recommended tests, exams, health education, biometric outcome goals, and vaccinations
will improve primary biometric outcomes.
2. Evaluate whether financial incentives for completing ADA recommended tests, exams,
health education, biometric outcome goals, and vaccinations will improve diabetes
patients' self-management as assessed by Summary of Diabetes Self-Care Activities
Measure (SDSCA) and 36-Item Short Form Health Survey (SF36v2).
3. Evaluate the extent to which financial incentives for healthy behaviors reduce the cost
of health care utilization.
Diabetes is the seventh leading cause of death in the United States (OECD 2013). It is also
known that certain populations are at greater risk for diabetes. In Hawaii, diabetes
disproportionally affects Native Hawaiians and Pacific Islanders as they are three times more
likely to be diagnosed with diabetes. In addition, in 2010 the U.S. Department of Health and
Human Services Office of Minority Health reported that Native Hawaiians/Pacific Islanders in
Hawaii were 5.7 times as likely as Caucasians living in Hawaii to die from diabetes(Office of
Minority Health, 2010).
In order to address the challenges that chronic diseases impose on individuals and the health
care system the Centers for Medicare & Medicaid Services (CMS) is assessing the impact of
incentivizing patients to increase self-care and disease management. Previous studies have
demonstrated that monetary incentives have been associated with an improvement in behavioral
outcomes, most notably when the incentive is received immediately following the targeted
behavior (Volpp, K.G., et.al., 2008; Mitchell, M.S., et.al., 2013). Cahill et al. (2008)
showed that economic incentives were tied to smoking cessation and led to a decrease in
relapse within a year. Our study seeks to build on these findings and determine whether
financial incentives may provide a way to improve diabetes self-management.
Data:
Electronic data (Labs, Outcomes) - January 1st, 2013 through December 31, 2015 Electronic
data (Claims) - January 1st, 2011 through December 31, 2015
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
| Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
| Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
| Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
| Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
| Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
| Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
| Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
| Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
| Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
| Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
| Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
| Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
| Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
| Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |