Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

NCT04075045 | Completed

• 1 other identifier: W000003
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension; Non-Adherence, Patient

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Blood Pressure Reduction

  Ninety (90) days.

• Blood Pressure Reduction

  Ninety (90) days.

• Compare the effectiveness of two types of incentives for blood pressure

  Ninety (90) days.

• Compare the effectiveness of two types of incentives for medication adherence

  Ninety (90) days.

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

  Ninety (90) days.

Study Arms (4)

Group A. Standard Care ("Control")

NO INTERVENTION

Does not receive Wellth app.

Group B. Wellth App ("Treatment 1")

EXPERIMENTAL

Receives Wellth app without additional financial rewards tied to adherence.

Behavioral: Wellth Smartphone App

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

EXPERIMENTAL

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; Behavioral: Targeted Incentives

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

EXPERIMENTAL

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; Behavioral: Non-Restricted Incentives

Interventions

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).

Group B. Wellth App ("Treatment 1"); Group C. Wellth App ("Treatment 2") with targeted rewards; Group D. Wellth App ("Treatment 3") with non-targeted rewards

Targeted Incentives BEHAVIORAL

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

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

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.

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable or unwilling to provide informed written consent

Sponsors & Collaborators

• Wellth Inc.: lead
• University of California, San Diego: collaborator

Study Sites (3)

UCSD

San Diego, California, 92093, United States

Location

Wellcare

New York, New York, 10004, United States

Location

Wellth

New York, New York, 11101, United States

Location

Related Publications (7)

• Nwankwo T, Yoon SS, Burt V, Gu Q. Hypertension among adults in the United States: National Health and Nutrition Examination Survey, 2011-2012. NCHS Data Brief. 2013 Oct;(133):1-8.

  PMID: 24171916 BACKGROUND

• 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.

  PMID: 15652604 BACKGROUND

• 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.

  PMID: 15908846 BACKGROUND

• 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.

  PMID: 23604493 BACKGROUND

• 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.

  PMID: 15194600 BACKGROUND

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

  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.

  PMID: 23771844 BACKGROUND

MeSH Terms

Conditions

Hypertension; Patient Compliance

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Uri Gneezy, Ph.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 30, 2019
• Study Start: September 2, 2019
• Primary Completion: July 23, 2020
• Study Completion: July 23, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)