Clinical trial NCT04029883: Behavioral Economics to Improve Antihypertensive Therapy Adherence
Official title: Behavioral Economics to Improve Antihypertensive Therapy Adherence (BETA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Medication Adherence
Keywords: hypertension
medication adherence
behavioral economics
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: RAND
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Electronically Measured Mean Medication Adherence During Intervention
timeFrame: 3 months
measure: Electronically Measured Mean Medication Adherence Post Intervention
timeFrame: 6 months post intervention
measure: Routinization of AH Adherence Post-intervention
timeFrame: 6 months post intervention
Secondary outcomes:
measure: Hypertension Control
timeFrame: 3 months and 9 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
citation: 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.