Behavioral Economics to Improve Antihypertensive Therapy Adherence

NCT04029883 | Completed Results DMC

• 2 other identifiers: Pro000577641R21HL156132-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension represents a major cardiovascular risk factor that can be controlled through the use of medications, yet medication non-adherence represents a common problem that leaves patients at elevated risk for adverse cardiovascular outcomes. Interventions to improve medication adherence have thus far been either unsuccessful or unsustainable. The investigators propose an intervention that leverages insights from behavioral economics to improve medication adherence among hypertensive patients. Strong data indicates that linking the taking of medications to daily routines ('anchoring') increases adherence, however, existing interventions built on this information have failed to create successful, long term improvements in medication adherence. This study aims to leverage behavioral economic insights to improve medication adherence to antihypertensive medications.

Conditions

Hypertension; Medication Adherence

Keywords

hypertension; medication adherence; behavioral economics

Outcome Measures

Primary Outcomes (3)

• Electronically Measured Mean Medication Adherence During Intervention

  The MEMS-data collected continuously over the course of the three-month intervention period will be used to calculate the primary adherence variable, which is defined as the percentage of timely (within 1 hour of anchor time) actual bottle openings out of the total number of prescribed bottle openings (# of actual once-a-day bottle openings within 1 hour of anchor time during the intervention period / # of prescribed once-a-day bottle openings during the intervention period). Only one of the anti-hypertension (AH) medications will be used to measure adherence

  3 months

• Electronically Measured Mean Medication Adherence Post Intervention

  MEMS data will also be collected continuously over the six-month post intervention period. These data will be used to evaluate the post-intervention mean adherence, whose definition is identical to the primary outcome 1: ratio of the number of actual bottle openings to the prescribed bottle openings.

  6 months post intervention

• Routinization of AH Adherence Post-intervention

  This measure would be calculated as the fraction of scheduled pills taken within a one-hour window around the typical time that participants report completing their existing routine behavior that anchors their pill-taking, for all visits made post-intervention.

  6 months post intervention

Secondary Outcomes (1)

• Hypertension Control

  3 months and 9 months

Study Arms (3)

Control Group

NO INTERVENTION

The Control group will receive care as usual, as well as a MEMS-cap and a leaflet explaining the importance of pill-taking routines and how to establish them. The study coordinator will spend approximately ten minutes with them to go over the leaflet and answer questions. Control group participants also spend time with the study coordinator at each clinic visit where contact information is updated, and any MEMS-cap problems are resolved. These procedures, which we successfully applied in previous studies, minimize the possibility that results are confounded by differences in attention or other non-specific effects between groups.

Message Group

ACTIVE COMPARATOR

The Message group will receive the same brief information session as the Control group but also receive daily text messages reinforcing the information provided for 3 months. A key insight from BE is that people typically are initially highly motivated to change their behavior, but their enthusiasm declines over time. To keep the importance of routinizing pill- taking salient (i.e. high on a person's mental priority list), we will send daily text messages using a freely available web platform. These messages will reinforce the information provided at recruitment, and remind participants of their personalized routinization strategy. Messages will be tailored and refreshed based on patient-specific factors including BP control, prior adherence, and current medication regimen.

Behavioral: Text Message

Incentive Group

EXPERIMENTAL

The Incentive group will receive the same information and text messages, but in addition have a chance of winning small, intermittent rewards for taking their medication at the time coinciding with their anchoring strategy. In this group, participants will be eligible for a prize drawing if they take their medication within +/- 1 hour of the time they carry out their existing routine behavior on at least 80% of days between clinic visits. When the participants return for their monthly visit, the study coordinator will download their MEMS-cap data and check whether this eligibility criteria was satisfied. MEMS software can be easily customized to display this information. If the patient qualifies, s/he is invited to draw one of three laminated cards with numbers 0, 25, and 50 out of a bag. The client receives the corresponding amount in USD in the form of a gift card immediately after the drawing.

Behavioral: Behavior Economic Incentive; Behavioral: Text Message

Interventions

Text Message BEHAVIORAL

A key insight from BE is that people typically are initially highly motivated to change their behavior, but their enthusiasm declines over time.103 To keep the importance of routinizing pill-taking salient (i.e. high on a person's mental priority list), we will send daily text messages using a freely available web platform.

Message Group

Behavior Economic Incentive BEHAVIORAL

In this group, participants will be eligible for a prize drawing if they take their medication within +/- 1 hour of the time they carry out their existing routine behavior on at least 80% of days between clinic visits.

Incentive Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• On anti-hypertensive medication (AH)
• Own, or have access to a phone at least five days a week throughout the duration of the intervention,
• Willing to receive study text messages

You may not qualify if:

• Under 18 years of age
• Not approved to participate by their provider
• Not willing to use MEMS caps
• Not mentally fit to provide voluntary consent
• Already enrolled in another comparable study

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• RAND: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• Ebinger JE, Ghai I, Barajas D, Vallejo R, Blyler CA, Morales M, Garcia N, Joung S, Palimaru A, Linnemayr S. Behavioural Economics to Improve Antihypertensive Therapy Adherence (BETA): protocol for a pilot randomised controlled trial in Los Angeles. BMJ Open. 2023 Jan 25;13(1):e066101. doi: 10.1136/bmjopen-2022-066101.

  PMID: 36697048 BACKGROUND

• Linnemayr S, Ghai I, Palimaru A, Barajas D, Vallejo R, Blyler CA, Morales EM, De Guzman M, Joung SY, Ungar S, Ebinger JE. Impact of behavioral economics to improve antihypertensive therapy adherence, a pilot randomized controlled trial in Los Angeles. Sci Rep. 2025 Nov 4;15(1):38452. doi: 10.1038/s41598-025-94805-5.

  PMID: 41188444 DERIVED

• Ghai I, Palimaru A, Ebinger JE, Barajas D, Vallejo R, Morales M, Linnemayr S. Barriers and facilitators of habit building for long-term adherence to antihypertensive therapy among people with hypertensive disorders in Los Angeles, California: a qualitative study. BMJ Open. 2024 Jul 11;14(7):e079401. doi: 10.1136/bmjopen-2023-079401.

  PMID: 38991671 DERIVED

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Joseph Ebinger
• Organization: Cedars-Sinai Medical Center

cda-research@cshs.org

424-315-2284

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: April 19, 2022
• Primary Completion: February 1, 2024
• Study Completion: July 31, 2024
• Last Updated: September 19, 2024
• Results First Posted: November 18, 2023

Record last verified: 2024-08

Locations

US (1)