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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

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
      • New York, New York, Stati Uniti, 11101
        • Wellth

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
Nessun intervento: Group A. Standard Care ("Control")
Does not receive Wellth app.
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).
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.
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

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

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

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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