Monetary Incentives and Intrinsic Motivation to Sustain Hypertension Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of California, Los Angeles.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01402453
First received: July 25, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Monetary Incentives
Behavioral: Intrinsic Motivation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Monetary Incentives and Intrinsic Motivation to Sustain Hypertension Control Pilot Study

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in and normalization of BP [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptability of the intervention and subjects' views regarding its impact. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 262
Study Start Date: August 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Subjects
Receive educational materials and a home BP monitor.
Experimental: Intervention Subjects
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.
Behavioral: Monetary Incentives
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.
Other Name: Behavioral economics
Behavioral: Intrinsic Motivation
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.
Other Name: Social Psychology

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Those whose BP's have returned to normal 1-2 weeks after the original obtained average reading.
  • Children, prisoners, institutionalized individuals, or pregnant women.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402453

Contacts
Contact: Estivali S. Villa 310-874-2800 evilla@mednet.ucla.edu

Locations
United States, California
St. John's Well Child and Family Center Compton W.M. Keck Foundation Clinic Building Not yet recruiting
Los Angeles, California, United States, 90007
St. John's Well Child and Family Center Dr. Louis C. Frayser Clinic Not yet recruiting
Los Angeles, California, United States, 90037
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Martin F. Shapiro, MD UCLA David Geffen School of Medicine
Study Director: José J. Escarce, MD, Ph.D UCLA David Geffen School of Medicine
Study Director: Craig R. Fox, Ph.D. UCLA Anderson School of Management
Study Director: Noah J. Goldstein, Ph.D. UCLA Anderson School of Management
Study Director: Honghu Liu, Ph.D. University of California, Los Angeles
Study Director: Suzanne B. Shu, Ph.D., MBA UCLA Anderson School of Management
Study Director: Ronald G. Victor, MD Cedars-Sinai Medical Center for Hypertension
  More Information

No publications provided

Responsible Party: Martin F. Shapiro, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01402453     History of Changes
Other Study ID Numbers: 11-008320, 1RC4AG039077-01
Study First Received: July 25, 2011
Last Updated: July 25, 2011
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
Incentives
Social psychology
Randomized trial
Hypertension
Intervention
Pilot Study

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014