Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hypertension, Non-Adherence, Patient

Intervention / Treatment
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* Behavioral: Wellth Smartphone App
* Behavioral: Targeted Incentives
* Behavioral: Non-Restricted Incentives


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Approximately 500 participants will be randomized into four groups (n=125 per group). Some groups will receive the Wellth app providing reminders and regimen tracking, and some groups may have the opportunity to earn financial rewards for their adherence.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A. Standard Care (Control)<br>Does not receive Wellth app. | |
| Experimental: Group B. Wellth App (Treatment 1)<br>Receives Wellth app without additional financial rewards tied to adherence. | Behavioral: Wellth Smartphone App<br>* 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).<br>|
| Experimental: Group C. Wellth App (Treatment 2) with targeted rewards<br>Receives Wellth app with additional ability to earn up to $150 rewards usable at local pharmacies for using the app to track adherence. | Behavioral: Wellth Smartphone App<br>* 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).<br>Behavioral: Targeted Incentives<br>* Participants may earn up financial rewards tied to their adherence. The rewards are only usable at pharmacies.<br>|
| Experimental: Group D. Wellth App (Treatment 3) with non-targeted rewards<br>Receives Wellth app with additional ability to earn up to $150 rewards usable at many stores for using the app to track adherence. | Behavioral: Wellth Smartphone App<br>* 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).<br>Behavioral: Non-Restricted Incentives<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication adherence | 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. | Ninety (90) days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High blood pressure, mobile health, behavioral economics, adherence, non-compliance