NCT01402453

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

July 25, 2011

Last Update Submit

March 7, 2015

Conditions

Keywords

IncentivesSocial psychologyRandomized trialHypertensionInterventionPilot Study

Outcome Measures

Primary Outcomes (1)

  • Change in and normalization of BP

    12 months

Secondary Outcomes (1)

  • Acceptability of the intervention and subjects' views regarding its impact.

    12 months

Study Arms (2)

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.

Behavioral: Monetary IncentivesBehavioral: Intrinsic Motivation

Interventions

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.

Also known as: Behavioral economics
Intervention Subjects

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.

Also known as: Social Psychology
Intervention Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Those whose BP's have returned to normal 1-2 weeks after the original obtained average reading.
  • Children, prisoners, institutionalized individuals, or pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. John's Well Child and Family Center Compton W.M. Keck Foundation Clinic Building

Los Angeles, California, 90007, United States

Location

St. John's Well Child and Family Center Dr. Louis C. Frayser Clinic

Los Angeles, California, 90037, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Interventions

Economics, BehavioralPsychology, Social

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PsychologyBehavioral SciencesBehavioral Disciplines and ActivitiesEconomicsHealth Care Economics and Organizations

Study Officials

  • Martin F. Shapiro, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • José J. Escarce, MD, Ph.D

    University of California, Los Angeles

    STUDY DIRECTOR
  • Craig R. Fox, Ph.D.

    University of California, Los Angeles

    STUDY DIRECTOR
  • Noah J. Goldstein, Ph.D.

    University of California, Los Angeles

    STUDY DIRECTOR
  • Honghu Liu, Ph.D.

    University of California, Los Angeles

    STUDY DIRECTOR
  • Suzanne B. Shu, Ph.D., MBA

    University of California, Los Angeles

    STUDY DIRECTOR
  • Ronald G. Victor, MD

    Cedars-Sinai Medical Center for Hypertension

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 25, 2011

First Posted

July 26, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2013

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations