<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01678183</url>
  </required_header>
  <id_info>
    <org_study_id>BU IRB H-30045</org_study_id>
    <secondary_id>WS2069417</secondary_id>
    <nct_id>NCT01678183</nct_id>
  </id_info>
  <brief_title>Financial Incentives for Medication Adherence</brief_title>
  <acronym>FIMA</acronym>
  <official_title>Financial Incentives for Medication Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Bureau of Economic Research, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a pilot study. The investigators have designed a randomized, controlled trial&#xD;
      of financial incentives in medication adherence, focusing primarily on poorly-controlled&#xD;
      diabetes, and secondarily on hypertension, and high cholesterol. Prior work has shown that&#xD;
      many patients do not take their medications as prescribed by their doctors. This contributes&#xD;
      to increased rates of bad outcomes such as blindness, kidney failure, heart attack, and&#xD;
      death. The investigators hypothesize that use of a financial incentive will motivate patients&#xD;
      to improve their medication adherence and ultimately their control of their chronic diseases.&#xD;
&#xD;
      The investigators plan to identify patients who get Primary Care at Boston Medical Center who&#xD;
      still have high blood sugars more than a year after their diabetes diagnosis, and randomize&#xD;
      them to a control arm, or one of two intervention arms. Subjects will be approached at the&#xD;
      time of a regularly-scheduled appointment with their Primary Care doctor and offered the&#xD;
      opportunity to participate in the study. All subjects who agree to participate in the study&#xD;
      will meet with a Clinical Pharmacologist to review their medications in detail, and then&#xD;
      undergo randomization. Subjects in the first intervention group will receive a cash incentive&#xD;
      for picking up medications for the targeted conditions from the pharmacy each month. Subjects&#xD;
      in the second intervention group will receive a cash incentive for picking up medications for&#xD;
      the targeted conditions from the pharmacy each month, and a one-time payment at the&#xD;
      conclusion of the study based on the amount of hemoglobin A1c decrease. The investigators&#xD;
      will enroll a total of 100 subjects in the study, and anticipate an observational cohort of&#xD;
      approximately 1,000 patients.&#xD;
&#xD;
      All patients who are eligible for the study but who are not enrolled in the study and have&#xD;
      not declined to participate in the study will become the observational cohort for the study.&#xD;
      The observational cohort will be used to determine whether randomization to the control arm&#xD;
      of the study has a negative, rather than neutral, effect on patients.&#xD;
&#xD;
      At the end of eight months, all subjects will meet with a Visiting Nurse in their home, to&#xD;
      have their blood pressure checked and to have their blood drawn so that their blood sugar and&#xD;
      cholesterol can be measured. Outcomes to be evaluated include hemoglobin A1c, lipid panel,&#xD;
      systolic blood pressure, diastolic blood pressure, self-reported health, microvascular and&#xD;
      macrovascular complications, and death.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in hemoglobin A1c</measure>
    <time_frame>8 months</time_frame>
    <description>The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in blood pressure.</measure>
    <time_frame>Eight months</time_frame>
    <description>The investigators will assess blood pressure measurements at the start and end of the study.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lipid levels</measure>
    <time_frame>Eight months</time_frame>
    <description>The investigators will assess lipid levels at the start and end of the study.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Hypertension</condition>
  <condition>Hyperlipidemia</condition>
  <arm_group>
    <arm_group_label>Monthly Incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monthly and Final Incentive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monthly Financial Incentive</intervention_name>
    <description>A cash payment.</description>
    <arm_group_label>Monthly Incentive</arm_group_label>
    <arm_group_label>Monthly and Final Incentive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Final Financial Incentive</intervention_name>
    <description>One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.</description>
    <arm_group_label>Monthly and Final Incentive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years&#xD;
&#xD;
          -  Speaks English, Spanish, or Haitian Creole&#xD;
&#xD;
          -  Established patient in Boston Medical Center Section of General Internal Medicine&#xD;
             Primary Care Practice&#xD;
&#xD;
          -  Uses Boston Medical Center Pharmacy&#xD;
&#xD;
          -  Diagnosed with diabetes for more than one year&#xD;
&#xD;
          -  Prescribed medications for diabetes&#xD;
&#xD;
          -  Last hemoglobin A1c &gt; 7.9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  History of Brittle Diabetes&#xD;
&#xD;
          -  Meets April, 2012 American Diabetes Association criteria for an increased goal&#xD;
             hemoglobin A1c&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Rourke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amitabh Chandra, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard Kennedy School, National Bureau of Economic Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katherine Baicker, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Public Health, National Bureau of Economic Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>January 30, 2015</last_update_submitted>
  <last_update_submitted_qc>January 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01678183
org study id: BU IRB H-30045
secondary id: WS2069417
nct id: NCT01678183
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in hemoglobin A1c
time frame: 8 months
description: The investigators will evaluate levels of blood sugar over time as measured by the hemoglobin A1c at the start and end of the study.
measure: Improvement in blood pressure.
time frame: Eight months
description: The investigators will assess blood pressure measurements at the start and end of the study.
measure: Lipid levels
time frame: Eight months
description: The investigators will assess lipid levels at the start and end of the study.
arm group label: Monthly Incentive
arm group type: Experimental
description: 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.
arm group label: Monthly and Final Incentive
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: No Intervention
description: These subjects will complete the enrollment process for the study but will be randomized to a group that receives usual care.
intervention type: Behavioral
intervention name: Monthly Financial Incentive
description: A cash payment.
arm group label: Monthly Incentive
arm group label: Monthly and Final Incentive
intervention type: Behavioral
intervention name: Final Financial Incentive
description: One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
arm group label: Monthly and Final Incentive
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Rourke, MD
role: Principal Investigator
affiliation: Boston Medical Center
last name: Amitabh Chandra, Ph.D.
role: Principal Investigator
affiliation: Harvard Kennedy School, National Bureau of Economic Research
last name: Katherine Baicker, Ph.D.
role: Principal Investigator
affiliation: Harvard School of Public Health, National Bureau of Economic Research
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hyperlipidemias