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Telehealth Intervention for Improved Blood Pressure Control With Targeted Incentives

21 de diciembre de 2020 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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 de estudio

Intervencionista

Inscripción (Actual)

97

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • San Diego, California, Estados Unidos, 92093
        • UCSD
    • New York
      • New York, New York, Estados Unidos, 10004
        • Wellcare
      • New York, New York, Estados Unidos, 11101
        • Wellth

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

50 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.
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.
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.
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medication adherence
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Pressure Reduction
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Ninety (90) days.
Evaluate and compare the average earned incentive values for participants in groups C and D
Ninety (90) days.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Uri Gneezy, Ph.D., University of California, San Diego

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

2 de septiembre de 2019

Finalización primaria (Actual)

23 de julio de 2020

Finalización del estudio (Actual)

23 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

27 de agosto de 2019

Primero enviado que cumplió con los criterios de control de calidad

27 de agosto de 2019

Publicado por primera vez (Actual)

30 de agosto de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de diciembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

21 de diciembre de 2020

Última verificación

1 de diciembre de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • W000003

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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