Diabetes MellitusFIMANCT01678183
Financial Incentives for Medication Adherence
A study testing Monthly Financial Incentive and Final Financial Incentive in people with Diabetes Mellitus and Hypertension, run by Boston Medical Center at 1 site in United States.
Trial summary
This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- What is being tested?
- Monthly Financial Incentive and Final Financial Incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age greater than or equal to 18 years
- Speaks English, Spanish, or Haitian Creole
- Established patient in Boston Medical Center Section of General Internal Medicine Primary Care Practice
- Uses Boston Medical Center Pharmacy
- Diagnosed with diabetes for more than one year
- Prescribed medications for diabetes
- Last hemoglobin A1c > 7.9
Who cannot join
- Pregnant
- History of Brittle Diabetes
- Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c
Trial locations and contacts
1 site in 1 country.
About this study
This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that many patients do not take their medications as prescribed by their doctors. This contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. The investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases.
The investigators plan to identify patients who get Primary Care at Boston Medical Center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. Subjects will be approached at the time of a regularly-scheduled appointment with their Primary Care doctor and offered the opportunity to participate in the study. All subjects who agree to participate in the study will meet with a Clinical Pharmacologist to review their medications in detail, and then undergo randomization. Subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients.
Read more
All patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. The observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients.
At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- Being tested
- Monthly Financial Incentive, Final Financial Incentive
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly Financial IncentiveBehavioural
A cash payment.
Final Financial IncentiveBehavioural
One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
| Study group | Role | What they receive |
|---|---|---|
| Monthly Incentive | Experimental | Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension, and hypercholesterolemia at the pharmacy on time. The intervention is the cash incentive. Receives: Behavioral: Monthly Financial Incentive |
| Monthly and Final Incentive | Experimental | Subjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension and hypercholesterolemia at the pharmacy on time, as well as an additional financial incentive for each full percentage point of decrease in their hemoglobin A1c over the eight-month course of the study. The two cash incentives are the intervention. Receives: Behavioral: Monthly Financial Incentive; Behavioral: Final Financial Incentive |
| Control | No intervention | These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in hemoglobin A1c
The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
Measured: 8 months
Secondary outcomes (1)
Improvement in blood pressure.
The investigators will assess blood pressure measurements at the start and end of the study.
Measured: Eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, National Bureau of Economic Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Rourke, MD, Principal investigator, Boston Medical CenterAmitabh Chandra, Ph.D., Principal investigator, Harvard Kennedy School, National Bureau of Economic ResearchKatherine Baicker, Ph.D., Principal investigator, Harvard School of Public Health, National Bureau of Economic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678183
- Sponsor's protocol ID
- BU IRB H-30045
- Other IDs
- WS2069417
- Acronym
- FIMA
- Status last verified
- Jan 2015
- First submitted
- 30 Aug 2012
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives for Medication Adherence
- ClinicalTrials.gov ID
- NCT01678183
- Acronym / sponsor ID
- FIMA / BU IRB H-30045
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer, National Bureau of Economic Research, Inc.
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot study. The investigators have designed a randomized, controlled trial of financial incentives in medication adherence, focusing primarily on poorly-controlled diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that many patients do not take their medications as prescribed by their doctors. This contributes to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and death. The investigators hypothesize that use of a financial incentive will motivate patients to improve their medication adherence and ultimately their control of their chronic diseases.
The investigators plan to identify patients who get Primary Care at Boston Medical Center who still have high blood sugars more than a year after their diabetes diagnosis, and randomize them to a control arm, or one of two intervention arms. Subjects will be approached at the time of a regularly-scheduled appointment with their Primary Care doctor and offered the opportunity to participate in the study. All subjects who agree to participate in the study will meet with a Clinical Pharmacologist to review their medications in detail, and then undergo randomization. Subjects in the first intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month. Subjects in the second intervention group will receive a cash incentive for picking up medications for the targeted conditions from the pharmacy each month, and a one-time payment at the conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators will enroll a total of 100 subjects in the study, and anticipate an observational cohort of approximately 1,000 patients.
All patients who are eligible for the study but who are not enrolled in the study and have not declined to participate in the study will become the observational cohort for the study. The observational cohort will be used to determine whether randomization to the control arm of the study has a negative, rather than neutral, effect on patients.
At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to have their blood pressure checked and to have their blood drawn so that their blood sugar and cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel, systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and macrovascular complications, and death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monthly Incentive | Experimental | Behavioral: Monthly Financial IncentiveSubjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension, and hypercholesterolemia at the pharmacy on time. The intervention is the cash incentive. |
| Monthly and Final Incentive | Experimental | Behavioral: Monthly Financial Incentive, Behavioral: Final Financial IncentiveSubjects in this arm will receive a cash incentive each month when they pick up their medications for diabetes, hypertension and hypercholesterolemia at the pharmacy on time, as well as an additional financial incentive for each full percentage point of decrease in their hemoglobin A1c over the eight-month course of the study. The two cash incentives are the intervention. |
| Control | No intervention | –These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than or equal to 18 years
- Speaks English, Spanish, or Haitian Creole
- Established patient in Boston Medical Center Section of General Internal Medicine Primary Care Practice
- Uses Boston Medical Center Pharmacy
- Diagnosed with diabetes for more than one year
Key exclusion criteria (3 listed)
- Pregnant
- History of Brittle Diabetes
- Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c
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 |
|---|---|---|
| Monthly Financial IncentiveA cash payment. | Behavioural | Monthly Incentive, Monthly and Final Incentive |
| Final Financial IncentiveOne-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study. | Behavioural | Monthly and Final Incentive |
Primary outcome
Improvement in hemoglobin A1c
Time frame: 8 months
The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
1 secondary outcome
Improvement in blood pressure.
Time frame: Eight months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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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.
Elizabeth Rourke, MD principal investigator
Boston Medical Center
Amitabh Chandra, Ph.D. principal investigator
Harvard Kennedy School, National Bureau of Economic Research
Katherine Baicker, Ph.D. principal investigator
Harvard School of Public Health, National Bureau of Economic Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly Financial Incentive and Final Financial Incentive in people with Diabetes Mellitus and Hypertension, run by Boston Medical Center 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 7 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 2 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in hemoglobin A1c (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2015.