- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04075045
Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives
21 dicembre 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
97
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
California
-
San Diego, California, Stati Uniti, 92093
- UCSD
-
-
New York
-
New York, New York, Stati Uniti, 10004
- Wellcare
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New York, New York, Stati Uniti, 11101
- Wellth
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
50 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Group A. Standard Care ("Control")
Does not receive Wellth app.
|
|
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Sperimentale: 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).
|
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Sperimentale: 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.
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Medication adherence
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Blood Pressure Reduction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
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Compare the effectiveness of two types of incentives for self-monitoring adherence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Ninety (90) days.
|
Evaluate and compare the average earned incentive values for participants in groups C and D
|
Ninety (90) days.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Uri Gneezy, Ph.D., University of California, San Diego
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
2 settembre 2019
Completamento primario (Effettivo)
23 luglio 2020
Completamento dello studio (Effettivo)
23 luglio 2020
Date di iscrizione allo studio
Primo inviato
27 agosto 2019
Primo inviato che soddisfa i criteri di controllo qualità
27 agosto 2019
Primo Inserito (Effettivo)
30 agosto 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 dicembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 dicembre 2020
Ultimo verificato
1 dicembre 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- W000003
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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