Pilot Study of Home Blood Pressure Control Program (eBPcontrol)
| Tracking Information | |||||
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| First Received Date ICMJE | July 1, 2011 | ||||
| Last Updated Date | July 15, 2011 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Percent of patients at BP goal [ Time Frame: Nine months ] [ Designated as safety issue: No ] Percentage of patients at systolic and/or diastolic blood pressure at goal at the fourth research visit (end of the study) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01387945 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pilot Study of Home Blood Pressure Control Program | ||||
| Official Title ICMJE | E-health BP Control Program | ||||
| Brief Summary | This intervention study will evaluate the feasibility,acceptability and effectiveness of an e-health enabled model of care by randomly assigning a trained patient navigator and/or a blood pressure (BP) self-management web portal to patients with uncontrolled hypertension after a run in period with a home BP monitor (HBPM) and comparing the results on blood pressure control. We anticipate that patients receiving the combination of a patient navigator(PN)with a self-management web portal and home BP monitor will have better BP control than when the only received a home BP monitor. |
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| Detailed Description | The study will demonstrate and evaluate the feasibility and acceptability of an e-health enabled model of care for improved hypertension and elevated blood pressure control using a home blood pressure monitor (HBPM), a blood pressure (BP) self-management web portal, and a trained patient navigator. During the first or the control period, all of the participants will have access to the only the HBPM. The control period will be compared to the final or the intervention period when the participants will gain access to a trained patient navigator and the web portal. This comparison will assist in estimating the effect sizes of the HBPM plus PN plus self-management web portal to HBPM alone for each of the outcomes: patient activation, self-management activities, medication adherence, reduced clinical inertia, and improved BP control. The second of the randomization periods will allocate a patient navigator to half of the participants, while the other half will gain access to only the web portal. We will compare the effectiveness of the PN plus webportal plus HBPM to webportal plus HBPM during this second period. An evaluation of the intervention process will delineate the barriers and facilitators by the providers, participants, and patient navigators. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: HBPM+website+patient navigator
In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator.
Other Name: Good Health Gateway |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01387945 | ||||
| Other Study ID Numbers ICMJE | NCT01242319, 1R21HS018238-01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Charles B. Eaton MD, Memorial Hospital of Rhode Island | ||||
| Study Sponsor ICMJE | Memorial Hospital of Rhode Island | ||||
| Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||
| Investigators ICMJE |
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| Information Provided By | Memorial Hospital of Rhode Island | ||||
| Verification Date | June 2011 | ||||
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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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