Hypertension Telemanagement in African Americans
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Self-Management; Adherence
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Primary purpose: Treatment