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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HS018238-01 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBPM only | No Intervention | ||
| HBPM+website+patient navigator | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBPM+website+patient navigator | Behavioral | In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients at BP goal | Percentage of patients at systolic and/or diastolic blood pressure at goal at the fourth research visit (end of the study) | Nine months |
| Measure | Description | Time Frame |
|---|---|---|
| Health status | SF-12 questionnaire, patient activation | Nine Months |
| Use of intervention tools | home blood pressure monitor-amount of time at goal; number of times patient utilized the website |
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Inclusion Criteria:
Diagnosed w/ hypertension or elevated blood pressure, uncontrolled blood pressure at the baseline research visit according to the following risk levels:
Vascular disease (cerebrovascular disease, coronary heart disease, diabetes mellitus, peripheral vascular disease, renal insufficiency)
SBP >130 mmHg or DBP >80 mmHg;
Left ventricular dysfunction,
SBP 120 mmHg or DBP >80 mmHg;
can read and understand English; must have access to internet
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles B Eaton, MD | Memorial Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hospital of Rhode Island | Pawtucket | Rhode Island | 02860 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Nine months |
| Costs | Nine months |
| D001519 | Behavior |