Diabetes MellitusHI-PRAISENCT02123251
Hawaii Patient Reward And Incentives to Support Empowerment
A study testing Financial Incentives in people with Diabetes Mellitus, run by University of Hawaii at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current pregnancy - gestational diabetes
- End-stage Renal Disease
- Does not speak English
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- 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).
- Evaluate the extent to which financial incentives for healthy behaviors reduce the cost of health care utilization.
Read the detailed description
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
- Conditions
- Diabetes Mellitus
- Being tested
- Financial Incentives
- Keywords
- Incentives,, Diabetes,, Medicaid,, Health behavior,, Cost effectiveness
- Medical subject headings
- Diabetes Mellitus, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesBehavioural
This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Financial Incentives Group | Experimental | Participants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys. Receives: Behavioral: Financial Incentives |
| Control Group | No intervention | Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c From Baseline to the End of Intervention (December 2015)
Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)
Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)
Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)
Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in Triglycerides From Baseline to the End of Intervention (December 2015)
Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in LDL From Baseline to the End of Intervention (December 2015)
Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in HDL From Baseline to the End of Intervention (December 2015)
Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Secondary outcomes (3)
Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers
Changes of total cost expenditures including emergency room use and hospitalizations in the intervention and control groups before and during intervention.
Measured: Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention)
Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure
SDSCA is a validated, self-reported measure assessing the average # of days the recommended diabetes self-care activities are performed over the past 7 days in the areas of general diet, specific diet, exercise, blood-glucose testing, and foot care at baseline, mid, and end of intervention. Possible scores range from 0 to 7 days. Change = (End of Intervention Score - Baseline Score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey
The SF-36v2 is validated, self reported short-form health survey used to assess changes over time in the well-being of participants. It consists of 2 component summary measures that further summarize 8 health domain scales. The Physical Component Summary (PCS) measure is derived from domain scales of Physical Functioning (10 items), Role-Physical (4 items), Bodily Pain (2 items), and General Health (5 items). Scores of component summary measures and health domain scales range from 0 to 100 with higher scores indicating better outcomes. Norm-based scoring was used so that scores for each health domain scale and component summary measure have a mean of 50 and standard deviation of 10 based on the 2009 U.S. general population. The SF-36v2 was used to assess participants' health and wellbeing at baseline, mid, and endpoint of intervention. Change = (Midpoint Score - Baseline Score)
Measured: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, Hawaii Department of Human Services (DHS), Kaiser Permanente, RTI International, IMPAQ International, LLC., Econometrica, Inc.
- Responsible party
- Principal investigator, Rebecca Rude Ozaki, University of Hawaii
- Investigators
- Ritabelle Fernandes, MD, Principal investigator, University of HawaiiRebecca R. Ozaki, PhD, Principal investigator, Unversity of Hawaii - Center on Disability Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123251
- Sponsor's protocol ID
- CDFA93.536 -CMS-MIPCD-HI
- Other IDs
- 1B1CMS330884-01
- Acronym
- HI-PRAISE
- Status last verified
- Feb 2019
- First submitted
- 15 Apr 2014
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers.
Publications
Organisation for Economic Co-Operation and Development (OECD), "Health Status: Life Expectancy at Birth, in Health at a Glance 2013: available at http://www.oecd.org/els/health-systems/Health-at-a-Glance-2013.pdf.
Office of Minority Health 2010. Diabetes Data/Statistics. Retrieved from http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=3&lvlid=62
Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
PubMed 19102784Mitchell MS, Goodman JM, Alter DA, John LK, Oh PI, Pakosh MT, Faulkner GE. Financial incentives for exercise adherence in adults: systematic review and meta-analysis. Am J Prev Med. 2013 Nov;45(5):658-67. doi: 10.1016/j.amepre.2013.06.017.
PubMed 24139781Cahill K, Perera R. Competitions and incentives for smoking cessation. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004307. doi: 10.1002/14651858.CD004307.pub3.
PubMed 18646105
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Incentive-Based Diabetes Self-Management Study (Hawaii Patient Reward And Incentives to Support Empowerment Project)
- ClinicalTrials.gov ID
- NCT02123251
- Acronym / sponsor ID
- HI-PRAISE / CDFA93.536 -CMS-MIPCD-HI
- Conditions
- Diabetes Mellitus
- Keywords
- Incentives,, Diabetes,, Medicaid,, Health behavior,, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, Hawaii Department of Human Services (DHS), Kaiser Permanente, RTI International, IMPAQ International, LLC., Econometrica, Inc.
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 30 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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).
- Evaluate the extent to which financial incentives for healthy behaviors reduce the cost of health care utilization.
Detailed description
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Financial Incentives Group | Experimental | Behavioral: Financial IncentivesParticipants (159) in the Incentive Group will: 1) continue to receive usual care; 2) are eligible to receive financial incentives based on completion of recommended ADA benchmarks and achievement of goals that are founded on evidence based guidelines for diabetes; and 3) be compensated for completion of surveys. |
| Control Group | No intervention | –Participants (161) in the Control Group will continue to receive usual care and be compensated for the completion of surveys only. They will not receive financial incentives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Current pregnancy - gestational diabetes
- End-stage Renal Disease
- Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial IncentivesThis intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle | Behavioural | Financial Incentives Group |
Primary outcome
Changes in HbA1c From Baseline to the End of Intervention (December 2015)
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in Hemoglobin A1c from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Systolic Blood Pressure From Baseline to the End of Intervention (December 2015)
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in systolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Diastolic Blood Pressure From Baseline to the End of Intervention (December 2015)
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in diastolic blood pressure from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Total Cholesterol From Baseline to the End of Intervention (December 2015)
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in total cholesterol from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in Triglycerides From Baseline to the End of Intervention (December 2015)
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in triglycerides from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in LDL From Baseline to the End of Intervention (December 2015)
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in LDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
Changes in HDL From Baseline to the End of Intervention (December 2015)
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Changes in HDL from baseline to end of study. Change = (End of Intervention score - Baseline score)
3 secondary outcomes
Changes in Health Utilization Cost Before and During Intervention - Amount Paid by Service Providers
Time frame: Before intervention (3 years prior to baseline) and during intervention (2 years from baseline to end of intervention)
Change From Baseline to End of Intervention (December 2015) in General Diet Subscale of The Summary of Diabetes Self-Care Activities (SDSCA) Measure
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Change From Baseline to End of Intervention (December 2015) in Physical Component Summary Measure of the Short Form (SF-36v2) Health Survey
Time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundOrganisation for Economic Co-Operation and Development (OECD), "Health Status: Life Expectancy at Birth, in Health at a Glance 2013: available at http://www.oecd.org/els/health-systems/Health-at-a-Glance-2013.pdf.
- BackgroundOffice of Minority Health 2010. Diabetes Data/Statistics. Retrieved from http://minorityhealth.hhs.gov/templates/browse.aspx?lvl=3&lvlid=62
- Background: PubMed 19102784Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.
- Background: PubMed 24139781Mitchell MS, Goodman JM, Alter DA, John LK, Oh PI, Pakosh MT, Faulkner GE. Financial incentives for exercise adherence in adults: systematic review and meta-analysis. Am J Prev Med. 2013 Nov;45(5):658-67. doi: 10.1016/j.amepre.2013.06.017.
- Background: PubMed 18646105Cahill K, Perera R. Competitions and incentives for smoking cessation. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004307. doi: 10.1002/14651858.CD004307.pub3.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritabelle Fernandes, MD principal investigator
University of Hawaii
Rebecca R. Ozaki, PhD principal investigator
Unversity of Hawaii - Center on Disability Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives in people with Diabetes Mellitus, run by University of Hawaii at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c From Baseline to the End of Intervention (December 2015) (time frame: Baseline to end of intervention - 12 months minimum to 19 months maximum due to rolling enrollment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123251, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.