Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224861
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2005-09-21
Brief Title:
Hypertension Telemanagement in African Americans
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Hypertension Telemanagement in African Americans
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients physician andor 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
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 patients physician andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL078579 | NIH | None | httpsreporternihgovquickSearchR01HL078579 |