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OpenTrials
Completed

NCT Number: NCT04075045

Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

Hypertension is the leading risk factor for cardiovascular disease, global mortality, and ranks third among the causes of disability. Treatment of hypertension is relatively straightforward, but patient adherence to long-term self-care strategies is problematically low. Three important behaviors that individuals can adhere to in order to help lower their BP are 1) Taking medications as prescribed by a physician, 2) Monitoring BP at home, and 3) Limiting dietary sodium intake. Adherence to these behaviors is problematic and currently ranges from 25% to 50%; the present Phase I STTR study is aimed at addressing the behavioral barriers for adherence to these three activities with the help of mobile technology. In particular, this STTR will develop and test an incentive program delivered through a mobile health app to increase adherence to prescribed BP control regimens and precipitate reduction in BP.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD, San Diego, California, United States

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About this study

Hypertension, or sustained systolic and diastolic blood pressure (BP) of 140 and 90 mmHg or higher, is among the most frequently encountered conditions in primary care in the U.S. The estimated prevalence is 30% among all U.S. adults and increases with age, reaching 65% for adults over 65 years of age. Hypertension is also the leading risk factor for cardiovascular disease, global mortality, and ranks third among the causes of disability. Treatment of hypertension is relatively straightforward, but patient adherence to long-term self-care strategies is problematically low. Three important behaviors that individuals can adhere to in order to help lower their BP are 1) Taking medications as prescribed by a physician, 2) Monitoring BP at home, and 3) Limiting dietary sodium intake. Adherence to these behaviors is problematic and currently ranges from 25% to 50%; the present Phase I STTR study is aimed at addressing the behavioral barriers for adherence to these three activities with the help of mobile technology. In particular, this STTR will develop and test an incentive program delivered through a mobile health app to increase adherence to prescribed BP control regimens and precipitate reduction in BP. The target participants for the test are adults with clinically diagnosed hypertension. The product to be developed is a mobile health app for patient smartphones, which delivers reminder triggers and immediate behavioral reinforcement through incentives to establish long-term habits. The incentives in each treatment arm are either purely financial or framed to target specific "mental accounts" to maximize the behavioral effectiveness of the intervention. The specific aims of the study are to (1) Demonstrate feasibility of combining behavioral economics with state-of-the-art telehealth technology to deliver an optimal incentive strategy to the specific group of patients to promote adherence and reduce BP, and (2) Compare the effectiveness of two types of incentives, i.e., pure financial and mental accounting, on BP and adherence to all three self-care activities: medications, BP monitoring, and meal logging. Phase II will test the efficacy of this approach in a larger and more diverse population to search for statistically and clinically significant improvements in blood pressure resulting from use of the app with the optimal incentive strategy. Initial customers are health insurers and risk-bearing hospital systems (e.g. those with value-based reimbursement models), who are fiscally responsible for healthcare expenses for large numbers of patients with poorly controlled BP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 50+
  • Has hypertension diagnosis
  • Owns a smartphone with sufficient data plan
  • Prescribed at least one daily oral antihypertensive agent
  • Prescription refill data shows <80% adherence in prior 12 months

Exclusion criteria

  • Unable or unwilling to provide informed written consent

Treatment and study plan

Wellth Smartphone App

Behavioral

Patients will receive the app that provides reminders to adhere to their self-care regimen and ability to track their daily adherence via photos of the self-care related items (medications, blood pressure cuff, meals).

Targeted incentives

Behavioral

Participants may earn up financial rewards tied to their adherence. The rewards are only usable at pharmacies.

Non-Restricted Incentives

Behavioral

Participants may earn up financial rewards tied to their adherence. The rewards are only usable at most stores, except for prohibited purchases such as alcohol, tobacco, or firearms, and is not redeemable for cash.

Primary outcomes

  1. Medication adherence

    Time frame: Ninety (90) days

    Improve medication adherence, as measured by prescription fill data or app adherence, in either Group C or D receiving financial incentives tied to adherence, as compared with Groups A or B receiving standard care or app with no additional incentives, respectively.

Secondary outcomes

  1. Blood Pressure Reduction

    Time frame: Ninety (90) days.

    Reduce BP in either Group C or D as compared to group A or B, as measured by data read from photos of weekly home BP measurement readouts submitted via the app

  2. Blood Pressure Reduction

    Time frame: Ninety (90) days.

    Compare BP across Groups B, C, and D as measured by data provided from photos of weekly home BP measurement readouts submitted via the app

  3. Compare the effectiveness of two types of incentives for blood pressure

    Time frame: Ninety (90) days.

    Compare the difference(s) in Groups C and D for blood pressure reading levels submitted via the app

  4. Compare the effectiveness of two types of incentives for medication adherence

    Time frame: Ninety (90) days.

    Compare the difference(s) in Groups C and D for adherence to prescribed medication (via the app and/or prescription data).

  5. Compare the effectiveness of two types of incentives for self-monitoring adherence

    Time frame: Ninety (90) days.

    Compare the difference(s) in Groups C and D for blood pressure self-monitoring adherence through the app.

  6. Compare the effectiveness of two types of incentives for meal logging adherence

    Time frame: Ninety (90) days.

    Compare the difference(s) in Groups C and D for meal logging adherence monitored and submitted through the app.

  7. Compare average incentive values earned by participants in group(s) C and D

    Time frame: Ninety (90) days.

    Evaluate and compare the average earned incentive values for participants in groups C and D

Sponsors and collaborators

Lead sponsor

Wellth Inc.

Industry

Collaborators

  • University of California, San Diego

Registry information

Official study title

Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives: Using New Technologies and Insights From Behavioral Economics to Increase the Effectiveness of Behavioral Change

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2019
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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