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Hypertension Telemanagement in African Americans

21 de março de 2013 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 estudo

Intervencional

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Joseph Finkelstein, University of Maryland

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2004

Conclusão Primária (Real)

1 de novembro de 2008

Conclusão do estudo (Real)

1 de novembro de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

21 de setembro de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de setembro de 2005

Primeira postagem (Estimativa)

23 de setembro de 2005

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

25 de março de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de março de 2013

Última verificação

1 de março de 2013

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 318
  • R01HL078579 (Concessão/Contrato do NIH dos EUA)

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