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Hypertension Telemanagement in African Americans

21 marzo 2013 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 di studio

Interventistico

Fase

  • Non applicabile

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

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

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: Trattamento
  • Assegnazione: Randomizzato

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Joseph Finkelstein, University of Maryland

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

1 settembre 2004

Completamento primario (Effettivo)

1 novembre 2008

Completamento dello studio (Effettivo)

1 novembre 2008

Date di iscrizione allo studio

Primo inviato

21 settembre 2005

Primo inviato che soddisfa i criteri di controllo qualità

21 settembre 2005

Primo Inserito (Stima)

23 settembre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

25 marzo 2013

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 marzo 2013

Ultimo verificato

1 marzo 2013

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 318
  • R01HL078579 (Sovvenzione/contratto NIH degli Stati Uniti)

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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