HypertensionBETANCT04029883
Behavioral Economics to Improve Antihypertensive Therapy Adherence
A study testing Text Message and Behavior Economic Incentive in people with Hypertension and Medication Adherence, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Medication Adherence
- What is being tested?
- Text Message and Behavior Economic Incentive
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Behavioral Economics to Improve Antihypertensive Therapy Adherence (BETA)
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.
Read the 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.
- Conditions
- Hypertension, Medication Adherence
- Being tested
- Text Message, Behavior Economic Incentive
- Keywords
- hypertension, medication adherence, behavioral economics
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessageBehavioural
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 IncentiveBehavioural
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 MessageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavior Economic Incentive; Behavioral: Text Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 6 months post intervention
Secondary outcomes (1)
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.
Measured: 3 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start19 Apr 2022
- Primary completion1 Feb 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- RAND, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joseph Ebinger, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029883
- Sponsor's protocol ID
- Pro00057764
- Other IDs
- 1R21HL156132-01
- Acronym
- BETA
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36697048Linnemayr 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.
PubMed 41188444Ghai 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.
PubMed 38991671
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Economics to Improve Antihypertensive Therapy Adherence (BETA)
- ClinicalTrials.gov ID
- NCT04029883
- Acronym / sponsor ID
- BETA / Pro00057764
- Conditions
- Hypertension, Medication Adherence
- Keywords
- hypertension, medication adherence, behavioral economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- RAND, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Text MessageThe 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. |
| Incentive Group | Experimental | Behavioral: Behavior Economic Incentive, Behavioral: Text MessageThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessageA 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. | Behavioural | Message Group |
| Behavior Economic IncentiveIn 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. | Behavioural | Incentive Group |
| Text MessageA 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. | Behavioural | Incentive Group |
Primary outcome
Electronically Measured Mean Medication Adherence During Intervention
Time frame: 3 months
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
Electronically Measured Mean Medication Adherence Post Intervention
Time frame: 6 months 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.
Routinization of AH Adherence Post-intervention
Time frame: 6 months 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.
1 secondary outcome
Hypertension Control
Time frame: 3 months and 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36697048Ebinger 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.
- Derived from this study: PubMed 41188444Linnemayr 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.
- Derived from this study: PubMed 38991671Ghai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message and Behavior Economic Incentive in people with Hypertension and Medication Adherence, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronically Measured Mean Medication Adherence During Intervention (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04029883, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.