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| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | September 10, 2009 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00158639 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Electronic Communications and Home Blood Pressure Monitoring | ||||
| Official Title ICMJE | Electronic Communications and Home Blood Pressure Monitoring | ||||
| Brief Summary | The control of blood pressure (BP) for patients with hypertension on medications has been elusive, despite the availability of evidence-based nationally recognized guidelines for treatment and 30 years of research addressing this. At present, less than 50% of patients with known hypertension are adequately controlled. If BP control could be improved, significant decreases in cardiovascular morbidity and mortality would occur. The purpose of this study is to conduct a randomized controlled trial of the effectiveness of the provision of home blood pressure measurement and electronic communications (secure messaging to health care providers) to improve hypertension control. |
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| Detailed Description | This is single-blind, randomized, controlled trial, to test the effectiveness of applying the chronic care model to hypertension. There is an emerging consensus that multifaceted, multilevel, interventions are most effective in improving care for chronic conditions. In order to successfully plan and execute the required strategies, care planning is being increasingly conducted by the use of systems planning models. Since its original description by Wagner, Austin and Von Korff in 1996, the Chronic Care Model has found wide application, acceptance and success in planning care for chronic diseases, however to our knowledge, it has not yet been applied to the care of hypertension. There are six components of the model, including: clinical information systems, decision support, delivery system design, self-management support, organizational support, and community resources. The model describes these components to activate both patients and physicians, and when this occurs optimally, health outcomes improve. The interventions below are designed according to this construct and to determine whether enhanced patient self-management support in the form of home blood pressure monitoring and augmented delivery system design with pharmaceutical care improves hypertension control.
The interventions will be delivered over a period of 12-months. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | Behavioral: Home BP;secure messaging;pharmaceutical care; | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, Carrell D, Tyll L, Larson EB, Thompson RS. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. 2008 Jun 25;299(24):2857-67. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 778 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00158639 | ||||
| Responsible Party | Dr. Helga Ding, Director of Operations, Group Health Research Institute | ||||
| Study ID Numbers ICMJE | R01 HL075263, R01 HL075263-01A1-01 | ||||
| Study Sponsor ICMJE | Group Health Cooperative | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Group Health Cooperative | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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