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Social Norms and Antihypertensive Medication Adherence

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ClinicalTrials.gov Identifier: NCT03292393
Recruitment Status : Withdrawn (Not enough sample list at participating healthcare facility.)
First Posted : September 25, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Florida International University

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.

Condition or disease Intervention/treatment Phase
Hypertension Medication Adherence Behavioral: Financial reward Behavioral: Social norms Device: Home Blood Pressure Monitoring Device: Medication adherence assessment Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Social Norms and Antihypertensive Medication Adherence
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group Contingency Management
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.
Behavioral: Financial reward
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

Behavioral: Social norms
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.

Device: Home Blood Pressure Monitoring
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

Device: Medication adherence assessment
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.
Other Name: eCap

Active Comparator: Individual Contingency Management
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.
Behavioral: Financial reward
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

Device: Home Blood Pressure Monitoring
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

Device: Medication adherence assessment
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.
Other Name: eCap

Placebo Comparator: Control Arm
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.
Device: Home Blood Pressure Monitoring
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

Device: Medication adherence assessment
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.
Other Name: eCap




Primary Outcome Measures :
  1. Self Assessed Medication Adherence [ Time Frame: Monthly over 8 months ]
    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 :
  1. Self Assessed Diastolic Blood pressure (mm Hg) [ Time Frame: Monthly over 8 months ]
    Self blood diastolic pressure reading with the HBPM device.

  2. Automatic measure of Medication Adherence [ Time Frame: Daily over 8 months ]
    Use the Research Electronic Data Capture (REDCap) system to gather a pill count to calculate the Medication Possession Ratio score.

  3. Self Assessed Systolic Blood pressure (mm Hg) [ Time Frame: Monthly over 8 months ]
    Self blood systolic pressure reading with the HBPM device.

  4. Automatic measure of Diastolic Blood pressure (mm Hg) [ Time Frame: Three times over 8 months ]
    Blood Diastolic pressure reading with the ABPM device.

  5. Automatic measure of Systolic Blood pressure (mm Hg) [ Time Frame: Three times over 8 months ]
    Blood Systolic pressure reading with the ABPM device.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292393


Sponsors and Collaborators
Florida International University
Investigators
Principal Investigator: Alejandro Arrieta, PhD Florida International University

Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT03292393     History of Changes
Other Study ID Numbers: IRB-15-0196
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Florida International University:
Hypertension
Medication
Adherence

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents