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Financial Incentives for Medication Adherence

Financial Incentives for Medication Adherence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01678183
Acronym
FIMA
Enrollment
74
Registered
2012-09-03
Start date
2012-09-30
Completion date
2015-01-31
Last updated
2015-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hyperlipidemia, Hypertension

Brief 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. 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.

Interventions

BEHAVIORALMonthly Financial Incentive

A cash payment.

BEHAVIORALFinal Financial Incentive

One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.

Sponsors

Pfizer
CollaboratorINDUSTRY
National Bureau of Economic Research, Inc.
CollaboratorOTHER
Boston Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Pregnant * History of Brittle Diabetes * Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c

Design outcomes

Primary

MeasureTime frameDescription
Improvement in hemoglobin A1c8 monthsThe investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.

Secondary

MeasureTime frameDescription
Improvement in blood pressure.Eight monthsThe investigators will assess blood pressure measurements at the start and end of the study.

Other

MeasureTime frameDescription
Lipid levelsEight monthsThe investigators will assess lipid levels at the start and end of the study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026