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Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

W

Wellth

Status

Completed

Conditions

Hypertension
Non-Adherence, Patient

Treatments

Behavioral: Targeted Incentives
Behavioral: Non-Restricted Incentives
Behavioral: Wellth Smartphone App

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04075045
W000003

Details and patient eligibility

About

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.

Full 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.

Enrollment

97 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

97 participants in 4 patient groups

Group A. Standard Care ("Control")
No Intervention group
Description:
Does not receive Wellth app.
Group B. Wellth App ("Treatment 1")
Experimental group
Description:
Receives Wellth app without additional financial rewards tied to adherence.
Treatment:
Behavioral: Wellth Smartphone App
Group C. Wellth App ("Treatment 2") with targeted rewards
Experimental group
Description:
Receives Wellth app with additional ability to earn up to $150 rewards usable at local pharmacies for using the app to track adherence.
Treatment:
Behavioral: Wellth Smartphone App
Behavioral: Targeted Incentives
Group D. Wellth App ("Treatment 3") with non-targeted rewards
Experimental group
Description:
Receives Wellth app with additional ability to earn up to $150 rewards usable at many stores for using the app to track adherence.
Treatment:
Behavioral: Wellth Smartphone App
Behavioral: Non-Restricted Incentives

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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