Completed

FIMAFinancial Incentives for Medication Adherence

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What is being tested

Monthly Financial Incentive

+ Monthly Financial Incentive

+ Final Financial Incentive

Behavioral
Who is being recruted

Cardiovascular Diseases+8

+ Endocrine System Diseases

+ Metabolic Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorBoston Medical Center
Last updated: February 2, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01678183
Principal SponsorBoston Medical Center
Last updated: February 2, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

74 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesVascular DiseasesGlucose Metabolism DisordersDyslipidemiasLipid Metabolism DisordersDiabetes MellitusHyperlipidemiasHypertension

Criteria

7 inclusion criteria required to participate
Age greater than or equal to 18 years

Diagnosed with diabetes for more than one year

Established patient in Boston Medical Center Section of General Internal Medicine Primary Care Practice

Last hemoglobin A1c > 7.9

Show More Criteria

3 exclusion criteria prevent from participating
History of Brittle Diabetes

Meets April, 2012 American Diabetes Association criteria for an increased goal hemoglobin A1c

Pregnant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Group III

No Intervention
These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Boston Medical Center

Boston, United StatesOpen Boston Medical Center in Google Maps
CompletedOne Study Center