Behavioral Economics to Improve Antihypertensive Therapy Adherence

Hypertension Clinical Trial

— BETA  

Official title:

Behavioral Economics to Improve Antihypertensive Therapy Adherence (BETA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04029883
• Other study ID #: Pro00057764
• Secondary ID: 1R21HL156132-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators propose to complement linking medication taking to a daily routine with two added components to make it easier for participants to stick to their anchoring plan: increasing information salience through frequent text messages and providing intermittent rewards for pill-taking according to the anchoring plan. This study will be implemented in a pilot randomized controlled trial (RCT) in a high-volume clinical practice to establish feasibility, acceptability, and preliminary efficacy. The specific aims include 1) a formative phase to develop the intervention and evaluate its feasibility and acceptability via focus groups with key stakeholders; 2) a RCT of 60 hypertensive patients in which a control group (n=20) is provided education on anchoring medication taking to a daily routine, and two intervention groups, one (n=20) who receives anchoring education and daily text message reminders and another (n=20) which receives anchoring education, text messages, and financial incentives for adherence in accordance with their anchoring plan; and 3) data collection in preparation for a future R01 application, including focus group discussions with key stakeholders (patients, providers [Physicians, Nurses, Advanced Care Practitioners, Pharmacists] and clinic staff) and exit focus groups with study participants regarding ways to improve the intervention. The main hypothesis is: the intervention is effective by anchoring pill-taking to an existing routine, tested by comparing the pooled (Message group + Incentive group) vs. the Control group. The secondary hypothesis is: adding incentives to the text messages is more effective for routinizing pill-taking (testing outcomes in the Incentive group vs. Message group). Outcomes from this study have the potential to greatly enhance our understanding of the barriers and facilitators of medication adherence among hypertensive patients and potentially provide evidence for a low-cost and scalable intervention to improve medication adherence in clinical practice. This pilot RCT will also include a smaller pilot of a novel data collection method, video diaries, using the Medallia Living Lens platform. A convenience sample of 30 participants (10 from each group) will be consented and enrolled, and will be asked to upload a short video in response to structured prompts once a week for three weeks. The prompts will be geared towards experiences with the study design and interventions, and the data collected will be analyzed using the Living Lens platform.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 18 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Hypertension
• Medication Adherence

Intervention

Behavioral:
• Text Message
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.
• Behavior Economic Incentive
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.
• Text Message
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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	National Heart, Lung, and Blood Institute (NHLBI), RAND

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Hypertension Control	This is a reliable biological measure of AH adherence since controlled blood pressure is correlated with high AH medication adherence. This measure will be defined as a binary variable indicating whether or not the blood pressure measured was < 130/80 mmHg. The measure will be calculated for two time periods: at the end of the intervention and at the end of the post-intervention period.	3 months and 9 months