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Hypertension Telemanagement in African Americans

2013년 3월 21일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

중재적

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Joseph Finkelstein, University of Maryland

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2004년 9월 1일

기본 완료 (실제)

2008년 11월 1일

연구 완료 (실제)

2008년 11월 1일

연구 등록 날짜

최초 제출

2005년 9월 21일

QC 기준을 충족하는 최초 제출

2005년 9월 21일

처음 게시됨 (추정)

2005년 9월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 3월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 3월 21일

마지막으로 확인됨

2013년 3월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 318
  • R01HL078579 (미국 NIH 보조금/계약)

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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