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Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

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ClinicalTrials.gov Identifier: NCT04075045
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypertension Non-Adherence, Patient Behavioral: Wellth Smartphone App Behavioral: Targeted Incentives Behavioral: Non-Restricted Incentives Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : September 2, 2019
Estimated Primary Completion Date : July 10, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Group A. Standard Care ("Control")
Does not receive Wellth app.
Experimental: Group B. Wellth App ("Treatment 1")
Receives Wellth app without additional financial rewards tied to adherence.
Behavioral: 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).

Experimental: 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.
Behavioral: 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).

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

Experimental: 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.
Behavioral: 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).

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.




Primary Outcome Measures :
  1. Medication adherence [ Time Frame: 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 :
  1. Blood Pressure Reduction [ Time Frame: Ninety (90) days. ]
    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

  2. Blood Pressure Reduction [ Time Frame: 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

  3. Compare the effectiveness of two types of incentives for blood pressure [ Time Frame: Ninety (90) days. ]
    Compare the difference(s) in Groups C and D for blood pressure reading levels submitted via the app

  4. Compare the effectiveness of two types of incentives for medication adherence [ Time Frame: Ninety (90) days. ]
    Compare the difference(s) in Groups C and D for adherence to prescribed medication (via the app and/or prescription data).

  5. Compare the effectiveness of two types of incentives for self-monitoring adherence [ Time Frame: Ninety (90) days. ]
    Compare the difference(s) in Groups C and D for blood pressure self-monitoring adherence through the app.

  6. Compare the effectiveness of two types of incentives for meal logging adherence [ Time Frame: Ninety (90) days. ]
    Compare the difference(s) in Groups C and D for meal logging adherence monitored and submitted through the app.

  7. Compare average incentive values earned by participants in group(s) C and D [ Time Frame: Ninety (90) days. ]
    Evaluate and compare the average earned incentive values for participants in groups C and D



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075045


Contacts
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Contact: Rudy Schmidt, MSPH, JD 303-956-1191 Rudy@wellthapp.com
Contact: Matthew Loper, BS (714) 235-1998 Matt@wellthapp.com

Locations
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United States, California
UCSD Not yet recruiting
San Diego, California, United States, 92093
Contact: Uri Gneezy, Ph.D.    858-534-4312    ugneezy@ucsd.edu   
United States, New York
Wellcare Recruiting
New York, New York, United States, 10004
Contact: James Greenough, BA       James.GreenoughIii@wellcare.com   
Principal Investigator: James Greenough, BA         
Wellth Not yet recruiting
New York, New York, United States, 11101
Contact: Rudy Schmidt, BA, MSPH, JD    303-956-1191    Rudy@wellthapp.com   
Contact: Kirstie Chen, BA, MS         
Principal Investigator: Kirstie Y Chen, BA, MS         
Sponsors and Collaborators
Wellth Inc.
University of California, San Diego
Investigators
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Principal Investigator: Uri Gneezy, Ph.D. University of California, San Diego
Additional Information:
Publications:
US Food & Drug Administration. FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food. 2016.
Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Böhm 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, Rydén 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.

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Responsible Party: Wellth Inc.
ClinicalTrials.gov Identifier: NCT04075045    
Other Study ID Numbers: W000003
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wellth Inc.:
High blood pressure
mobile health
behavioral economics
adherence
non-compliance
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases