Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

Not Applicable

Completed

• Conditions: Hypertension; Non-Adherence, Patient
• Interventions: Behavioral: Wellth Smartphone App; Behavioral: Targeted Incentives; Behavioral: Non-Restricted Incentives

• Registration Number: NCT04075045
• Lead Sponsor: Wellth Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-30
• Study Start: 2019-09-02
• Primary Completion: 2020-07-23
• Study Completion: 2020-07-23
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B. Wellth App ("Treatment 1")	Wellth Smartphone App	Receives Wellth app without additional financial rewards tied to adherence.
Group C. Wellth App ("Treatment 2") with targeted rewards	Wellth Smartphone App	Receives Wellth app with additional ability to earn up to $150 rewards usable at local pharmacies for using the app to track adherence.
Group D. Wellth App ("Treatment 3") with non-targeted rewards	Wellth Smartphone App	Receives Wellth app with additional ability to earn up to $150 rewards usable at many stores for using the app to track adherence.
Group C. Wellth App ("Treatment 2") with targeted rewards	Targeted Incentives	Receives Wellth app with additional ability to earn up to $150 rewards usable at local pharmacies for using the app to track adherence.
Group D. Wellth App ("Treatment 3") with non-targeted rewards	Non-Restricted Incentives	Receives Wellth app with additional ability to earn up to $150 rewards usable at many stores for using the app to track adherence.

Primary Outcome Measures

Name	Time	Method
Medication adherence	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 Outcome Measures

Name	Time	Method
Blood Pressure Reduction	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
Compare average incentive values earned by participants in group(s) C and D	Ninety (90) days.	Evaluate and compare the average earned incentive values for participants in groups C and D
Compare the effectiveness of two types of incentives for medication adherence	Ninety (90) days.	Compare the difference(s) in Groups C and D for adherence to prescribed medication (via the app and/or prescription data).
Compare the effectiveness of two types of incentives for meal logging adherence	Ninety (90) days.	Compare the difference(s) in Groups C and D for meal logging adherence monitored and submitted through the app.
Compare the effectiveness of two types of incentives for blood pressure	Ninety (90) days.	Compare the difference(s) in Groups C and D for blood pressure reading levels submitted via the app
Compare the effectiveness of two types of incentives for self-monitoring adherence	Ninety (90) days.	Compare the difference(s) in Groups C and D for blood pressure self-monitoring adherence through the app.

Trial Locations

Locations (3)

Wellcare; 🇺🇸 New York, New York, United States

UCSD; 🇺🇸 San Diego, California, United States

Wellth; 🇺🇸 New York, New York, United States