Social Norms and Antihypertensive Medication Adherence

NCT03292393 | Withdrawn

• 1 other identifier: IRB-15-0196
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension; Medication Adherence

Keywords

Hypertension; Medication; Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self Assessed Diastolic Blood pressure (mm Hg)

  Monthly over 8 months

• Automatic measure of Medication Adherence

  Daily over 8 months

• Self Assessed Systolic Blood pressure (mm Hg)

  Monthly over 8 months

• Automatic measure of Diastolic Blood pressure (mm Hg)

  Three times over 8 months

• Automatic measure of Systolic Blood pressure (mm Hg)

  Three times over 8 months

Study Arms (3)

Group Contingency Management

ACTIVE COMPARATOR

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; Behavioral: Social norms; Device: Home Blood Pressure Monitoring; Device: Medication adherence assessment

Individual Contingency Management

ACTIVE COMPARATOR

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; Device: Home Blood Pressure Monitoring; Device: Medication adherence assessment

Control Arm

PLACEBO COMPARATOR

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; Device: Medication adherence assessment

Interventions

Financial reward BEHAVIORAL

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

Group Contingency Management; Individual Contingency Management

Social norms BEHAVIORAL

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.

Group Contingency Management

Home Blood Pressure Monitoring DEVICE

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

Control Arm; Group Contingency Management; Individual Contingency Management

Medication adherence assessment DEVICE

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.

Also known as: eCap

Control Arm; Group Contingency Management; Individual Contingency Management

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida International University: lead

MeSH Terms

Conditions

Hypertension; Medication Adherence

Interventions

Blood Pressure Monitoring, Ambulatory

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Blood Pressure Determination; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Alejandro Arrieta, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: September 25, 2017
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share