- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04075045
Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives
2020년 12월 21일 업데이트: 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.
연구 개요
상태
완전한
상세 설명
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.
연구 유형
중재적
등록 (실제)
97
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
California
-
San Diego, California, 미국, 92093
- UCSD
-
-
New York
-
New York, New York, 미국, 10004
- Wellcare
-
New York, New York, 미국, 11101
- Wellth
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Group A. Standard Care ("Control")
Does not receive Wellth app.
|
|
|
실험적: 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).
|
|
실험적: 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.
|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Medication adherence
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Blood Pressure Reduction
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Ninety (90) days.
|
Evaluate and compare the average earned incentive values for participants in groups C and D
|
Ninety (90) days.
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Uri Gneezy, Ph.D., University of California, San Diego
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2019년 9월 2일
기본 완료 (실제)
2020년 7월 23일
연구 완료 (실제)
2020년 7월 23일
연구 등록 날짜
최초 제출
2019년 8월 27일
QC 기준을 충족하는 최초 제출
2019년 8월 27일
처음 게시됨 (실제)
2019년 8월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 12월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 12월 21일
마지막으로 확인됨
2020년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Wellth Smartphone App에 대한 임상 시험
-
Chad Stecher@asu.eduNational Heart, Lung, and Blood Institute (NHLBI); Arizona State University; Wellth Inc.모병
-
University of Electronic Science and Technology...모병
-
Haukeland University HospitalWestern Norway University of Applied Sciences아직 모집하지 않음
-
Leiden University Medical CenterMedical Center Haaglanden; Groene Hart Ziekenhuis; Reinier de Graaf Groep; Alrijne Ziekenhuis... 그리고 다른 협력자들모병
-
Ohio State UniversityWashington University School of Medicine; University of Illinois at Chicago; Vanderbilt University...모병
-
Chang Gung University of Science and TechnologyChang Gung Memorial Hospital; Ministry of Science and Technology, Taiwan모병
-
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical...완전한