Social Norms and Antihypertensive Medication Adherence

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Medication Adherence
• Intervention / Treatment: Behavioral: Financial reward; Behavioral: Social norms; Device: Home Blood Pressure Monitoring; Device: Medication adherence assessment

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
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: eCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Monthly over 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Assessed Diastolic Blood pressure (mm Hg)	Self blood diastolic pressure reading with the HBPM device.	Monthly over 8 months
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.	Daily over 8 months
Self Assessed Systolic Blood pressure (mm Hg)	Self blood systolic pressure reading with the HBPM device.	Monthly over 8 months
Automatic measure of Diastolic Blood pressure (mm Hg)	Blood Diastolic pressure reading with the ABPM device.	Three times over 8 months
Automatic measure of Systolic Blood pressure (mm Hg)	Blood Systolic pressure reading with the ABPM device.	Three times over 8 months

Collaborators and Investigators

• Sponsor: Florida International University
• Investigators: Principal Investigator: Alejandro Arrieta, PhD, Florida International University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Adherence; Hypertension; Medication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB-15-0196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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