HypertensionNCT01402453
Monetary Incentives and Intrinsic Motivation to Sustain Hypertension Control
A study testing Monetary Incentives and Intrinsic Motivation in people with Hypertension, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Despite unequivocal proof that tight control of blood pressure with antihypertensive medication can prevent hypertensive complications-including strokes, myocardial infarcts, heart failure, end-stage renal disease, and death- blood pressure remains uncontrolled in the majority of individuals with hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Monetary Incentives and Intrinsic Motivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2011to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 18 or older who are receiving ongoing medical care at the clinic (one or more routine visits in the year prior to the visit during the study enrollment period at which their blood pressure is found to be abnormal), are capable of giving consent, and live at a fixed address.
- Must state that they intend to continue to receive care in the clinic.
- Measured BP is greater than 140mm systolic or 90mm diastolic (or 130/80 respectively for "high risk" subjects with: diabetes, established coronary artery disease, prior cardiovascular event, left ventricular hypertrophy by ECG, chronic kidney disease, or diagnosed heart failure).
Who cannot join
- Those whose BP's have returned to normal 1-2 weeks after the original obtained average reading.
- Children, prisoners, institutionalized individuals, or pregnant women.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. John's Well Child and Family Center Compton W.M. Keck Foundation Clinic Building
Los Angeles, California, 90007
St. John's Well Child and Family Center Dr. Louis C. Frayser Clinic
Los Angeles, California, 90037
About this study
Official title: Monetary Incentives and Intrinsic Motivation to Sustain Hypertension Control Pilot Study
Despite unequivocal proof that tight control of blood pressure with antihypertensive medication can prevent hypertensive complications-including strokes, myocardial infarcts, heart failure, end-stage renal disease, and death- blood pressure remains uncontrolled in the majority of individuals with hypertension. We propose a novel patient-centered intervention that combines monetary incentives and a social psychological intervention to help patients sustain blood pressure control once incentives are no longer offered by strengthening intrinsic motivation to control blood pressure among two vulnerable populations: African Americans, who suffer disproportionately from hypertension, and Mexican Americans, who have the lowest hypertension control rates of any demographic group in the United States. If the intervention is successful, it could be adapted as a set of tools to apply in clinical practice to improve outcomes of a range of chronic diseases, by maximizing the motivation of patients to optimize their treatment.
Read the detailed description
We propose to test the translation of behavioral economics and social psychology theory and experience in other domains into an intervention that has the potential to improve control of hypertension and diminish its health impact. Blood pressure control requires that: (1) the patient see a physician; (2) the disease be recognized by the physician, (3) a medicine be prescribed; (4) the patient take the medicine; (5) the patient come back for additional visits to monitor the treatment; (6) the provider make adjustments as needed in the therapy; and (7) the patient adhere to the changes and continue to come in for monitoring. Factors interfere with this chain of events even among patients with a regular source of care, such as a community clinic. Due to the asymptomatic nature of the disease, lack of awareness of the consequences of uncontrolled BP, discounting of these consequences because they occur in the distant future, health beliefs that lead the individual not to believe that the treatment would be beneficial, competing demands, financial barriers, or medication side effects, these patients may not monitor their BP as often as they should, press their physicians about BP control, or adhere to medication regimens. For their part, physicians may not intensify treatment as indicated.
How would the combination of incentives that we propose in this study work in hypertension management? Monetary incentives could improve BP control by leading patients to monitor their BP and make physician visits for hypertension more frequently, "activating" patients to be more assertive about discussing treatment intensification with their providers when their BP is elevated or other issues regarding their therapy, and improving medication adherence. Thus a patient whose BP readings continue to be elevated because he or she is receiving inadequate monotherapy for their level of hypertension might be more motivated to remember to take their pills, check their readings regularly, and most importantly, get to the doctor to intensify the regimen when faced with a monetary incentive to reduce BP. Similarly, another patient might be more motivated to speak up and tell their physician that they are having trouble taking their current BP medicine because of its side-effects; rather that stopping their medication and suffering the consequences of uncontrolled hypertension, this "activated" patient may stimulate the physician to prescribe a different class of medicine that effectively controls the BP without side-effects. Although this experience may give the patient insight that they can get their blood pressure under control and keep it there for some time, the same concerns that initially interfered with BP control may lead patients to return to previous habits after the monetary incentive is withdrawn. They may be busy and not make the time to check their blood pressure, refill prescriptions, take their medicine, or see their doctor. For this reason, helping the patient identify intrinsic motivations to control their BP is necessary. Intrinsic motivations would help keep the patient continually aware of what is at stake (in terms of the people they care about, their roles in society, and their activities) if they do not take their medicines, fill their prescriptions, or follow up with the provider when blood pressure readings are not at target.
The challenge of achieving and sustaining hypertension control might usefully borrow terminology from clinical oncology, in which many treatments have 3 phases: induction, consolidation, and maintenance. For hypertension, we can envision a similar framework: induction of normal blood pressure through initiation and adjustment of medications and adherence to them (for which we expect monetary incentives to be most effective); consolidation in which the patient maintains a normal blood pressure for a period of time (reinforced by frequent feedback, ongoing incentives, and interventions aimed at making intrinsic motivations salient); and maintenance after withdrawal of the incentives, which can be reinforced by success reducing blood pressure coupled with identity priming and identity labeling to engender strong intrinsic motivation to continue.
- Conditions
- Hypertension
- Being tested
- Monetary Incentives, Intrinsic Motivation
- Keywords
- Incentives, Social psychology, Randomized trial, Hypertension, Intervention, Pilot Study
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monetary IncentivesBehavioural
Also called Behavioral economics
Subjects will receive a payment of $2 per mm. drop in BP from the baseline value at each follow-up visit. If a subject reaches their target BP, they will receive a minimum of $30 each time to motivate continued participation in the study and reinforce continued improvement relative to baseline BP. Lottery incentives will be added to motivate attainment of intermediate goals. For remembering to do certain actions that assist in the management of their BP, the subject will receive one entry into a lottery with an expected value of $3 per ticket. For the lottery payment, the subject will be given 3 chances to randomly select a card that may or may not show a winning monetary prize.
Intrinsic MotivationBehavioural
Also called Social Psychology
A)Subjects will complete an additional component to the baseline questionnaire that probes systematically for areas of experience that currently are of importance to them. Their answers will help to identify patients' intrinsic motivations for controlling their BP. B)Answers to this component will be analyzed to characterize a role self-identity that will be used by study personnel to frame their interactions with the subject for the remainder of the study. C) Role identity will be kept highly salient throughout the study by using identity primes that remind the individual that improving blood pressure levels is an important responsibility associated with that role.
| Study group | Role | What they receive |
|---|---|---|
| Control Subjects | No intervention | Receive educational materials and a home BP monitor. |
| Intervention Subjects | Experimental | Receive educational materials and a home BP monitor, as well as monetary incentives tied to amount of improvement in BP from baseline and a personalized intervention to internalize motivation for BP control. Monthly monetary incentives will cease after 6 months. Receives: Behavioral: Monetary Incentives; Behavioral: Intrinsic Motivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in and normalization of BP
Measured: 12 months
Secondary outcomes (1)
Acceptability of the intervention and subjects' views regarding its impact.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Martin Shapiro, University of California, Los Angeles
- Investigators
- Martin F. Shapiro, MD, Principal investigator, University of California, Los AngelesJosé J. Escarce, MD, Ph.D, Study director, University of California, Los AngelesCraig R. Fox, Ph.D., Study director, University of California, Los AngelesNoah J. Goldstein, Ph.D., Study director, University of California, Los AngelesHonghu Liu, Ph.D., Study director, University of California, Los AngelesSuzanne B. Shu, Ph.D., MBA, Study director, University of California, Los AngelesRonald G. Victor, MD, Study director, Cedars-Sinai Medical Center for Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402453
- Sponsor's protocol ID
- 11-008320
- Other IDs
- 1RC4AG039077-01
- Status last verified
- Mar 2015
- First submitted
- 25 Jul 2011
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shapiro MF, Shu SB, Goldstein NJ, Victor RG, Fox CR, Tseng CH, Vangala S, Mogler BK, Reed SB, Villa E, Escarce JJ. Impact of a Patient-Centered Behavioral Economics Intervention on Hypertension Control in a Highly Disadvantaged Population: a Randomized Trial. J Gen Intern Med. 2020 Jan;35(1):70-78. doi: 10.1007/s11606-019-05269-z. Epub 2019 Sep 12.
PubMed 31515735
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monetary Incentives and Intrinsic Motivation to Sustain Hypertension Control Pilot Study
- ClinicalTrials.gov ID
- NCT01402453
- Acronym / sponsor ID
- 11-008320
- Conditions
- Hypertension
- Keywords
- Incentives, Social psychology, Randomized trial, Hypertension, Intervention, Pilot Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite unequivocal proof that tight control of blood pressure with antihypertensive medication can prevent hypertensive complications-including strokes, myocardial infarcts, heart failure, end-stage renal disease, and death- blood pressure remains uncontrolled in the majority of individuals with hypertension. We propose a novel patient-centered intervention that combines monetary incentives and a social psychological intervention to help patients sustain blood pressure control once incentives are no longer offered by strengthening intrinsic motivation to control blood pressure among two vulnerable populations: African Americans, who suffer disproportionately from hypertension, and Mexican Americans, who have the lowest hypertension control rates of any demographic group in the United States. If the intervention is successful, it could be adapted as a set of tools to apply in clinical practice to improve outcomes of a range of chronic diseases, by maximizing the motivation of patients to optimize their treatment.
Detailed description
We propose to test the translation of behavioral economics and social psychology theory and experience in other domains into an intervention that has the potential to improve control of hypertension and diminish its health impact. Blood pressure control requires that: (1) the patient see a physician; (2) the disease be recognized by the physician, (3) a medicine be prescribed; (4) the patient take the medicine; (5) the patient come back for additional visits to monitor the treatment; (6) the provider make adjustments as needed in the therapy; and (7) the patient adhere to the changes and continue to come in for monitoring. Factors interfere with this chain of events even among patients with a regular source of care, such as a community clinic. Due to the asymptomatic nature of the disease, lack of awareness of the consequences of uncontrolled BP, discounting of these consequences because they occur in the distant future, health beliefs that lead the individual not to believe that the treatment would be beneficial, competing demands, financial barriers, or medication side effects, these patients may not monitor their BP as often as they should, press their physicians about BP control, or adhere to medication regimens. For their part, physicians may not intensify treatment as indicated.
How would the combination of incentives that we propose in this study work in hypertension management? Monetary incentives could improve BP control by leading patients to monitor their BP and make physician visits for hypertension more frequently, "activating" patients to be more assertive about discussing treatment intensification with their providers when their BP is elevated or other issues regarding their therapy, and improving medication adherence. Thus a patient whose BP readings continue to be elevated because he or she is receiving inadequate monotherapy for their level of hypertension might be more motivated to remember to take their pills, check their readings regularly, and most importantly, get to the doctor to intensify the regimen when faced with a monetary incentive to reduce BP. Similarly, another patient might be more motivated to speak up and tell their physician that they are having trouble taking their current BP medicine because of its side-effects; rather that stopping their medication and suffering the consequences of uncontrolled hypertension, this "activated" patient may stimulate the physician to prescribe a different class of medicine that effectively controls the BP without side-effects. Although this experience may give the patient insight that they can get their blood pressure under control and keep it there for some time, the same concerns that initially interfered with BP control may lead patients to return to previous habits after the monetary incentive is withdrawn. They may be busy and not make the time to check their blood pressure, refill prescriptions, take their medicine, or see their doctor. For this reason, helping the patient identify intrinsic motivations to control their BP is necessary. Intrinsic motivations would help keep the patient continually aware of what is at stake (in terms of the people they care about, their roles in society, and their activities) if they do not take their medicines, fill their prescriptions, or follow up with the provider when blood pressure readings are not at target.
The challenge of achieving and sustaining hypertension control might usefully borrow terminology from clinical oncology, in which many treatments have 3 phases: induction, consolidation, and maintenance. For hypertension, we can envision a similar framework: induction of normal blood pressure through initiation and adjustment of medications and adherence to them (for which we expect monetary incentives to be most effective); consolidation in which the patient maintains a normal blood pressure for a period of time (reinforced by frequent feedback, ongoing incentives, and interventions aimed at making intrinsic motivations salient); and maintenance after withdrawal of the incentives, which can be reinforced by success reducing blood pressure coupled with identity priming and identity labeling to engender strong intrinsic motivation to continue.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Subjects | No intervention | –Receive educational materials and a home BP monitor. |
| Intervention Subjects | Experimental | Behavioral: Monetary Incentives, Behavioral: Intrinsic MotivationReceive educational materials and a home BP monitor, as well as monetary incentives tied to amount of improvement in BP from baseline and a personalized intervention to internalize motivation for BP control. Monthly monetary incentives will cease after 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 or older who are receiving ongoing medical care at the clinic (one or more routine visits in the year prior to the visit during the study enrollment period at which their blood pressure is found to be abnormal), are capable of giving consent, and live at a fixed address.
- Must state that they intend to continue to receive care in the clinic.
- Measured BP is greater than 140mm systolic or 90mm diastolic (or 130/80 respectively for "high risk" subjects with: diabetes, established coronary artery disease, prior cardiovascular event, left ventricular hypertrophy by ECG, chronic kidney disease, or diagnosed heart failure).
Key exclusion criteria (2 listed)
- Those whose BP's have returned to normal 1-2 weeks after the original obtained average reading.
- Children, prisoners, institutionalized individuals, or pregnant women.
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 |
|---|---|---|
| Monetary IncentivesAlso: Behavioral economicsSubjects will receive a payment of $2 per mm. drop in BP from the baseline value at each follow-up visit. If a subject reaches their target BP, they will receive a minimum of $30 each time to motivate continued participation in the study and reinforce continued improvement relative to baseline BP. Lottery incentives will be added to motivate attainment of intermediate goals. For remembering to do certain actions that assist in the management of their BP, the subject will receive one entry into a lottery with an expected value of $3 per ticket. For the lottery payment, the subject will be given 3 chances to randomly select a card that may or may not show a winning monetary prize. | Behavioural | Intervention Subjects |
| Intrinsic MotivationAlso: Social PsychologyA)Subjects will complete an additional component to the baseline questionnaire that probes systematically for areas of experience that currently are of importance to them. Their answers will help to identify patients' intrinsic motivations for controlling their BP. B)Answers to this component will be analyzed to characterize a role self-identity that will be used by study personnel to frame their interactions with the subject for the remainder of the study. C) Role identity will be kept highly salient throughout the study by using identity primes that remind the individual that improving blood pressure levels is an important responsibility associated with that role. | Behavioural | Intervention Subjects |
Primary outcome
Change in and normalization of BP
Time frame: 12 months
1 secondary outcome
Acceptability of the intervention and subjects' views regarding its impact.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Derived from this study: PubMed 31515735Shapiro MF, Shu SB, Goldstein NJ, Victor RG, Fox CR, Tseng CH, Vangala S, Mogler BK, Reed SB, Villa E, Escarce JJ. Impact of a Patient-Centered Behavioral Economics Intervention on Hypertension Control in a Highly Disadvantaged Population: a Randomized Trial. J Gen Intern Med. 2020 Jan;35(1):70-78. doi: 10.1007/s11606-019-05269-z. Epub 2019 Sep 12.
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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.
Martin F. Shapiro, MD principal investigator
University of California, Los Angeles
José J. Escarce, MD, Ph.D study director
University of California, Los Angeles
Craig R. Fox, Ph.D. study director
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monetary Incentives and Intrinsic Motivation in people with Hypertension, run by University of California, Los Angeles at 2 sites 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 3 inclusion and 2 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in and normalization of BP (time frame: 12 months). 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 NCT01402453, which also lists 1 linked publication.
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 10 Mar 2015.