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Social Norms and Antihypertensive Medication Adherence

Primary Purpose

Hypertension, Medication Adherence

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Financial reward
Social norms
Home Blood Pressure Monitoring
Medication adherence assessment
Sponsored by
Florida International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Hypertension, Medication, Adherence

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Person has been diagnosed with essential hypertension for at least a year (no new or recently diagnosed hypertensive patients)
  • Person is currently taking no more than 2 medications
  • Person has taken the same anti-hypertensive medication for at least a year (no recent changes in medication)
  • Person reports not being adherent to anti-hypertensive medication
  • Speaks English or Spanish, currently insured
  • Has access to the Internet
  • Willing to participate in social media, able to go to West Kendall Baptist Hospital
  • Available for the next 8 months

Exclusion Criteria:

  • Persons with Secondary hypertension
  • Persons with coronary heart disease, cerebrovascular disorders or atrial fibrillation,
  • Persons with rubber allergy, or bedridden, wheelchair bound.
  • Persons who have had a stroke or myocardial infarction within the previous 6 months, are pregnant, or have any serious chronic disease will also be excluded from the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Group Contingency Management

    Individual Contingency Management

    Control Arm

    Arm Description

    During the intervention phase, the Group Contingency Management (GCM) arm will continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a home blood pressure monitoring reading using the HBPM. Participants in the GCM arm will receive a payment after each phone call, dependent on their medication adherence assessment. The GCM arm will also receive an additional payment based on their group's medication adherence.The intervention administered is the Financial Reward and Social Norms.

    During the intervention phase, those in the Individual Contingency Management (ICM) arm will also continue to take their hypertensive medication for the four-month period but will receive a payment after each phone call, dependent on their medication adherence assessment.The intervention administered is the Financial Reward.

    During the intervention phase, those in the control arm will be asked to continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a blood pressure reading using the HBPM. Those in the control arm will only be paid for their participation in the study regardless of medication adherence assessment.

    Outcomes

    Primary Outcome Measures

    Self Assessed Medication Adherence
    Use self reported personal pill count to calculate the Medication Possession Ratio score, this ratio is explained in the protocol and can explain how multiple measurements will be aggregated to arrive at one reported value.

    Secondary Outcome Measures

    Self Assessed Diastolic Blood pressure (mm Hg)
    Self blood diastolic pressure reading with the HBPM device.
    Automatic measure of Medication Adherence
    Use the Research Electronic Data Capture (REDCap) system to gather a pill count to calculate the Medication Possession Ratio score.
    Self Assessed Systolic Blood pressure (mm Hg)
    Self blood systolic pressure reading with the HBPM device.
    Automatic measure of Diastolic Blood pressure (mm Hg)
    Blood Diastolic pressure reading with the ABPM device.
    Automatic measure of Systolic Blood pressure (mm Hg)
    Blood Systolic pressure reading with the ABPM device.

    Full Information

    First Posted
    February 13, 2017
    Last Updated
    November 6, 2018
    Sponsor
    Florida International University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03292393
    Brief Title
    Social Norms and Antihypertensive Medication Adherence
    Official Title
    Social Norms and Antihypertensive Medication Adherence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not enough sample list at participating healthcare facility.
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Florida International University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study objective is to build group social norms to improve individual adhere to antihypertensive medications. Financial incentives are provided to individuals contingent upon group behavioral changes. Groups of patients will be formed, and incentivized to interact on a daily basis through social media and participate in a monthly-facilitated meeting at a local clinic. By forming groups, making individual outcomes transparent, and setting financial incentives contingent to group targets, individual decisions are framed within emerging social norms.
    Detailed Description
    We propose a pilot study that will inform, provide inputs and reduce the risk of a larger implementation. The project consists of three phases: The pre-intervention phase, the intervention phase, and the post-intervention phase. The pre-intervention phase includes the recruitment and selection of participants, and a one-month collection of baseline blood pressure and medication adherence levels of participants before they are assigned to a treatment arm. All participants will receive compensation for participation. In the intervention phase participants will be randomly assigned to one of the three treatment arms and they will receive the financial incentive that corresponds to their treatment arm. Data will be collected for four months and all participants will continue receiving a compensation for participation. During the post-intervention phase, contingency payments will be cut off, and only compensation for participation will remain. Data will be collected for three months in the post-intervention phase. The primary outcome of the study is medication adherence which will be measured using two different methods. The first method is through the use of eCaps (electronic caps). The second method is through a monthly randomized phone call during which the participant will be asked to perform a pill count of their medication. The secondary outcome of the study is blood pressure which will be measured using two different instruments . The first instrument will be the ambulatory blood pressure monitor (ABPM). The second instrument will be a home blood pressure monitor (HBPM) which researchers will provide to the participant to use for the duration of the study. All participants of the study will receive an unconditional payment each time they provide a blood pressure reading from the ABPM. Financial incentives (contingent to change in behavior -conditional to change in adherence). In addition to the unconditional payment, participants in the ICM and GCM treatment arms will receive a financial incentive that is conditional to medication adherence.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Medication Adherence
    Keywords
    Hypertension, Medication, Adherence

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Contingency Management
    Arm Type
    Active Comparator
    Arm Description
    During the intervention phase, the Group Contingency Management (GCM) arm will continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a home blood pressure monitoring reading using the HBPM. Participants in the GCM arm will receive a payment after each phone call, dependent on their medication adherence assessment. The GCM arm will also receive an additional payment based on their group's medication adherence.The intervention administered is the Financial Reward and Social Norms.
    Arm Title
    Individual Contingency Management
    Arm Type
    Active Comparator
    Arm Description
    During the intervention phase, those in the Individual Contingency Management (ICM) arm will also continue to take their hypertensive medication for the four-month period but will receive a payment after each phone call, dependent on their medication adherence assessment.The intervention administered is the Financial Reward.
    Arm Title
    Control Arm
    Arm Type
    Placebo Comparator
    Arm Description
    During the intervention phase, those in the control arm will be asked to continue to take their hypertensive medication for the four-month period and will receive a randomized phone call once a month to obtain a pill count and a blood pressure reading using the HBPM. Those in the control arm will only be paid for their participation in the study regardless of medication adherence assessment.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Financial reward
    Intervention Description
    In contingency management, financial rewards are contingent upon an individual changing behavior. In our study, financial incentives are contingent upon group behavioral changes.. In the intervention phase participants will be randomly assigned to one of the three treatment arms and they will receive the financial incentive that corresponds to their treatment arm. Data will be collected for four months and all participants will continue receiving a compensation for participation
    Intervention Type
    Behavioral
    Intervention Name(s)
    Social norms
    Intervention Description
    To build social norms the study adds a group component to a contingency management model. In contingency management, financial rewards are contingent upon an individual changing behavior. Social norms are expected to emerge as a result of the designed group contingency management, monthly-facilitated meetings at a local clinic, and daily basis interaction through social media. The intervention will build social norms that improve medication adherence of each member of a group. A three-arm randomize trial is designed to test this hypothesis. Hypertensive patients will be randomly assigned to a group contingency management (GCM) arm, an individual contingency management (ICG) arm, or a control arm.
    Intervention Type
    Device
    Intervention Name(s)
    Home Blood Pressure Monitoring
    Intervention Description
    Participants will be reminded that they will receive and learn how to use a Home Blood Pressure Monitor (HBPM) device that participant will keep for the duration of the study
    Intervention Type
    Device
    Intervention Name(s)
    Medication adherence assessment
    Other Intervention Name(s)
    eCap
    Intervention Description
    Participants will be informed that they will receive and learn how to use eCap, a medication event monitoring system that participants will return after completing the study. The project nursing student will count the number of pills the participant currently has and make a record of it on the Data Collection form.The participant will provide the project nursing student with his/her antihypertension prescription records so that the dosage amount and number of pills can be recorded on the Data Collection form.
    Primary Outcome Measure Information:
    Title
    Self Assessed Medication Adherence
    Description
    Use self reported personal pill count to calculate the Medication Possession Ratio score, this ratio is explained in the protocol and can explain how multiple measurements will be aggregated to arrive at one reported value.
    Time Frame
    Monthly over 8 months
    Secondary Outcome Measure Information:
    Title
    Self Assessed Diastolic Blood pressure (mm Hg)
    Description
    Self blood diastolic pressure reading with the HBPM device.
    Time Frame
    Monthly over 8 months
    Title
    Automatic measure of Medication Adherence
    Description
    Use the Research Electronic Data Capture (REDCap) system to gather a pill count to calculate the Medication Possession Ratio score.
    Time Frame
    Daily over 8 months
    Title
    Self Assessed Systolic Blood pressure (mm Hg)
    Description
    Self blood systolic pressure reading with the HBPM device.
    Time Frame
    Monthly over 8 months
    Title
    Automatic measure of Diastolic Blood pressure (mm Hg)
    Description
    Blood Diastolic pressure reading with the ABPM device.
    Time Frame
    Three times over 8 months
    Title
    Automatic measure of Systolic Blood pressure (mm Hg)
    Description
    Blood Systolic pressure reading with the ABPM device.
    Time Frame
    Three times over 8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Person has been diagnosed with essential hypertension for at least a year (no new or recently diagnosed hypertensive patients) Person is currently taking no more than 2 medications Person has taken the same anti-hypertensive medication for at least a year (no recent changes in medication) Person reports not being adherent to anti-hypertensive medication Speaks English or Spanish, currently insured Has access to the Internet Willing to participate in social media, able to go to West Kendall Baptist Hospital Available for the next 8 months Exclusion Criteria: Persons with Secondary hypertension Persons with coronary heart disease, cerebrovascular disorders or atrial fibrillation, Persons with rubber allergy, or bedridden, wheelchair bound. Persons who have had a stroke or myocardial infarction within the previous 6 months, are pregnant, or have any serious chronic disease will also be excluded from the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alejandro Arrieta, PhD
    Organizational Affiliation
    Florida International University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Social Norms and Antihypertensive Medication Adherence

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