N/A
Completed N=320
Hawaii Patient Reward And Incentives to Support Empowerment
Source: ClinicalTrials.gov NCT02123251 ↗Enrolled (actual)
320
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Changes in HbA1c From Baseline to the End of Intervention (December 2015) — 0.0660; -0.3440 percentage of glycosylated hemoglobin — p=0.0553
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in HbA1c From Baseline to the End of Intervention (December 2015) |
0.0660; -0.3440 | 0.0553 |
| PRIMARY Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015) |
-1.3579; 0.9337 | 0.2416 |
| PRIMARY Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015) |
-2.1895; -1.1002 | 0.3881 |
| PRIMARY Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015) |
-3.9141; 2.5709 | 0.8617 |
| PRIMARY Changes in Triglycerides From Baseline to the End of Intervention (December 2015) |
0.4843; 18.2713 | 0.5333 |
| PRIMARY Changes in LDL From Baseline to the End of Intervention (December 2015) |
0.4523; 1.3620 | 0.8620 |
| PRIMARY Changes in HDL From Baseline to the End of Intervention (December 2015) |
0.6705; -0.0472 | 0.4915 |
| SECONDARY Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers |
-0.185; -0.203 | >0.05 |
| SECONDARY Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure |
0.7796; 0.1393 | 0.0420 sig |
| SECONDARY Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey |
0.5162; -1.6027 | .0399 sig |
Eligibility Criteria
Inclusion Criteria
- Clinically diagnosed with diabetes mellitus
- 18 years of age or older
- Medicaid recipient
- At recruitment has an HbA1c level of ≥ 6.5
- At recruitment is receiving care coordination at Kaiser Permanente Hawaii
Exclusion Criteria
- Current pregnancy - gestational diabetes
- End-stage Renal Disease
- Does not speak English
Data sourced from ClinicalTrials.gov (NCT02123251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.