Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

NCT ID: NCT04075045

Last Updated: 2020-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2020-07-23

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.

Conditions

Hypertension; Non-Adherence, Patient

Keywords

High blood pressure; mobile health; behavioral economics; adherence; non-compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A. Standard Care ("Control")

Does not receive Wellth app.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B. Wellth App ("Treatment 1")

Receives Wellth app without additional financial rewards tied to adherence.

Group Type: EXPERIMENTAL

Wellth Smartphone App

Intervention Type: 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).

Group C. Wellth App ("Treatment 2") with targeted rewards

Receives Wellth app with additional ability to earn up to $150 rewards usable at local pharmacies for using the app to track adherence.

Group Type: EXPERIMENTAL

Wellth Smartphone App

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Group D. Wellth App ("Treatment 3") with non-targeted rewards

Receives Wellth app with additional ability to earn up to $150 rewards usable at many stores for using the app to track adherence.

Group Type: EXPERIMENTAL

Wellth Smartphone App

Intervention Type: 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).

Non-Restricted Incentives

Intervention Type: 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.

Interventions

Wellth Smartphone App

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).

Intervention Type: BEHAVIORAL

Targeted Incentives

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

Intervention Type: BEHAVIORAL

Non-Restricted Incentives

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Wellth Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uri Gneezy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD

San Diego, California, United States

Wellcare

New York, New York, United States

Wellth

New York, New York, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 24171916 (View on PubMed)

Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005 Jan 15-21;365(9455):217-23. doi: 10.1016/S0140-6736(05)17741-1.

Reference Type: BACKGROUND

PMID: 15652604 (View on PubMed)

Sokol MC, McGuigan KA, Verbrugge RR, Epstein RS. Impact of medication adherence on hospitalization risk and healthcare cost. Med Care. 2005 Jun;43(6):521-30. doi: 10.1097/01.mlr.0000163641.86870.af.

Reference Type: BACKGROUND

PMID: 15908846 (View on PubMed)

Ostchega Y, Berman L, Hughes JP, Chen TC, Chiappa MM. Home blood pressure monitoring and hypertension status among US adults: the National Health and Nutrition Examination Survey (NHANES), 2009-2010. Am J Hypertens. 2013 Sep;26(9):1086-92. doi: 10.1093/ajh/hpt054. Epub 2013 Apr 19.

Reference Type: BACKGROUND

PMID: 23604493 (View on PubMed)

Cappuccio FP, Kerry SM, Forbes L, Donald A. Blood pressure control by home monitoring: meta-analysis of randomised trials. BMJ. 2004 Jul 17;329(7458):145. doi: 10.1136/bmj.38121.684410.AE. Epub 2004 Jun 11.

Reference Type: BACKGROUND

PMID: 15194600 (View on PubMed)

US Food & Drug Administration. FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food. 2016.

Reference Type: BACKGROUND

Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M, Christiaens T, Cifkova R, De Backer G, Dominiczak A, Galderisi M, Grobbee DE, Jaarsma T, Kirchhof P, Kjeldsen SE, Laurent S, Manolis AJ, Nilsson PM, Ruilope LM, Schmieder RE, Sirnes PA, Sleight P, Viigimaa M, Waeber B, Zannad F, Redon J, Dominiczak A, Narkiewicz K, Nilsson PM, Burnier M, Viigimaa M, Ambrosioni E, Caufield M, Coca A, Olsen MH, Schmieder RE, Tsioufis C, van de Borne P, Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S, Clement DL, Coca A, Gillebert TC, Tendera M, Rosei EA, Ambrosioni E, Anker SD, Bauersachs J, Hitij JB, Caulfield M, De Buyzere M, De Geest S, Derumeaux GA, Erdine S, Farsang C, Funck-Brentano C, Gerc V, Germano G, Gielen S, Haller H, Hoes AW, Jordan J, Kahan T, Komajda M, Lovic D, Mahrholdt H, Olsen MH, Ostergren J, Parati G, Perk J, Polonia J, Popescu BA, Reiner Z, Ryden L, Sirenko Y, Stanton A, Struijker-Boudier H, Tsioufis C, van de Borne P, Vlachopoulos C, Volpe M, Wood DA. 2013 ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J. 2013 Jul;34(28):2159-219. doi: 10.1093/eurheartj/eht151. Epub 2013 Jun 14. No abstract available.

Reference Type: BACKGROUND

PMID: 23771844 (View on PubMed)

Other Identifiers

W000003

Identifier Type: -

Identifier Source: org_study_id