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Hypertension Telemanagement in African Americans

21 de marzo de 2013 actualizado por: Dr. Joseph Finkelstein, Johns Hopkins University

The specific goals of this project are to (1) refine the Home Automated Telemanagement (HAT) program according to the JNC 7 Report based on focus group review conducted by the key personnel, primary care providers, and patients and to fully implement the multidisciplinary model for hypertension telemanagement in African Americans as an adjunct of ambulatory care and (2) evaluate in a randomized clinical trial the impact of HAT on hypertension care delivery and on patients' clinical outcomes using both clinic- and patient-level variables. The comparison will be made with the standard of hypertension care recommended by the JNC 7 Report.

The following primary hypothesis related to clinic-level outcomes will be tested: Use of HAT will be associated (1) with improved proportion of treated patients who achieve blood pressure goals meeting JNC 7 recommendations, and (2) with a significant reduction in systolic and diastolic blood pressure. Researchers will also explore the impact of HAT on physician awareness and use of the hypertension treatment guidelines promulgated by the JNC 7 Report.

The following secondary exploratory hypothesis related to patient-level outcomes will be evaluated: The HAT program will have a positive impact on behavioral and cognitive factors that play an important role in the process of patient self-management, including hypertension treatment self-efficacy, health locus of control, health beliefs, and hypertension knowledge. Researchers will also investigate the impact of HAT on patients' compliance with multi-component treatment plans (including adherence to medication regimens and therapeutic lifestyle changes) and explore the effect of the HAT system on patients' ability to reach dietary, physical activity, weight control, and sodium consumption goals recommended by the JNC 7 Report.

During this study researchers will explore the impact of HAT on patient satisfaction with medical care, health-related quality of life, and health services utilization. Researchers will also assess acceptance of the HAT system by both patients and providers. Finally, researchers will perform a cost-effectiveness analysis of using the HAT system for hypertension control.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

BACKGROUND:

Recent studies demonstrated that successful chronic disease management requires a coordinated effort that includes health care providers who follow recent clinical guidelines in their everyday practice, educated patients who are adherent to their prescribed treatment plans, and comprehensive patient-provider communication. Studies employing telecommunication technologies have been successful in affecting the major components of chronic disease care, including physician practice patterns, patient adherence to therapy, and patient-provider communication. These studies were focused mainly on an improvement of a single component of the clinical care process. To date there have been no studies evaluating a coordinated approach that concurrently employs all of these components in an integrated framework linked to primary care. In this study researchers propose to evaluate a multi-component telemanagement system providing integrated support to both clinicians and patients in implementing hypertension treatment guidelines according to the JNC 7 Report.

DESIGN NARRATIVE:

Researchers will use the HAT system as a test platform for their intervention. The HAT system was developed to facilitate implementation of current clinical guidelines and to provide an integrated, multi-component chronic disease management intervention. HAT was designed as an Internet-based telemedicine system that (1) provides ongoing education to patients about their chronic disease, (2) helps patients follow their self-care plans, and (3) helps health care practitioners treat and monitor their patients' self-management process according to current clinical guidelines. The HAT system consists of (1) patient units (a computer or palmtop connected with a disease-specific testing device, such as a blood pressure monitor), (2) a HAT server that analyzes and stores self-testing results, and (3) clinician units that are used to review patient results on the Web. During each telecommunication session patients perform self-testing and receive structured disease-specific education, patient-tailored counseling, and advice on how to follow their individual self-care plans based on the current results of self-testing. The information for patients includes text, audio, and video components. In instances of patient noncompliance with self-testing, medication nonadherence, or failure to follow the physician-prescribed treatment plan, the system gives feedback to the patient to motivate better compliance and alerts the patient's physician and/or nurse who may contact the patient as well. This design can be easily adapted for any chronic condition by utilizing an appropriate disease-specific testing device and reprogramming decision support logic according to the particular disease management guidelines. In previous studies researchers have demonstrated (1) a high level of acceptance of the HAT system by patients from a low-income, inner-city area without previous computer experience, (2) acceptance of the system by physicians and nurses taking care of their patients, and (3) the validity of self-testing results in adult patients who used HAT. The system is currently being used to evaluate efficacy of home telemanagement of patients with asthma in the NIH- and ALA-funded studies. In this proposed study, researchers seek to advance their understanding of the applicability and utility of the HAT technology by focusing on its impact on African Americans with hypertension.

Tipo de estudio

Intervencionista

Fase

  • No aplica

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

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patient must have a primary care provider at one of the clinics participating in the study
  • Physician diagnosis of hypertension
  • 21 years of age or older at the time of randomization
  • African American by self-report
  • Taking at least one medication prescribed for hypertension
  • Poorly controlled blood pressure
  • Understand spoken English
  • Have a home telephone
  • No other member of the household enrolled in the study

Exclusion Criteria:

  • An identified secondary cause of hypertension
  • Symptomatic myocardial infarction or stroke within the past 6 months
  • Congestive heart failure (NYHA class III or greater)
  • Significant renal impairment
  • Diseases likely to lead to noncardiovascular death over the course of the study
  • Evidence that the patient may move from the study area before the completion of the study
  • Presence of any health condition that would preclude participation (e.g., psychiatric diagnosis or physical disability)
  • Active drug use

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: Tratamiento
  • Asignación: Aleatorizado

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Joseph Finkelstein, University of Maryland

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

1 de septiembre de 2004

Finalización primaria (Actual)

1 de noviembre de 2008

Finalización del estudio (Actual)

1 de noviembre de 2008

Fechas de registro del estudio

Enviado por primera vez

21 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

21 de septiembre de 2005

Publicado por primera vez (Estimar)

23 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

25 de marzo de 2013

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

21 de marzo de 2013

Última verificación

1 de marzo de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 318
  • R01HL078579 (Subvención/contrato del NIH de EE. UU.)

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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