Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives
2020年12月21日 更新者:Wellth Inc.
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
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.
研究概览
地位
完全的
详细说明
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.
研究类型
介入性
注册 (实际的)
97
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
California
-
San Diego、California、美国、92093
- UCSD
-
-
New York
-
New York、New York、美国、10004
- Wellcare
-
New York、New York、美国、11101
- Wellth
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:Group A. Standard Care ("Control")
Does not receive Wellth app.
|
|
|
实验性的:Group B. Wellth App ("Treatment 1")
Receives Wellth app without additional financial rewards tied to adherence.
|
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).
|
|
实验性的: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.
|
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).
Participants may earn up financial rewards tied to their adherence.
The rewards are only usable at pharmacies.
|
|
实验性的: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.
|
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).
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.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Medication adherence
大体时间: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.
|
Ninety (90) days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood Pressure Reduction
大体时间: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
|
Ninety (90) days.
|
|
Blood Pressure Reduction
大体时间: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
|
Ninety (90) days.
|
|
Compare the effectiveness of two types of incentives for blood pressure
大体时间:Ninety (90) days.
|
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
大体时间:Ninety (90) days.
|
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
大体时间:Ninety (90) days.
|
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
大体时间:Ninety (90) days.
|
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
大体时间:Ninety (90) days.
|
Evaluate and compare the average earned incentive values for participants in groups C and D
|
Ninety (90) days.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员:Uri Gneezy, Ph.D.、University of California, San Diego
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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. Erratum In: BMJ. 2004 Aug 28;329(7464):499.
- 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.
- 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.
- US Food & Drug Administration. FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food. 2016.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年9月2日
初级完成 (实际的)
2020年7月23日
研究完成 (实际的)
2020年7月23日
研究注册日期
首次提交
2019年8月27日
首先提交符合 QC 标准的
2019年8月27日
首次发布 (实际的)
2019年8月30日
研究记录更新
最后更新发布 (实际的)
2020年12月22日
上次提交的符合 QC 标准的更新
2020年12月21日
最后验证
2020年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.