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Pilot Study of Home Blood Pressure Control Program (eBP Control) (eBPcontrol)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01387945
First Posted: July 6, 2011
Last Update Posted: April 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Charles B. Eaton, Memorial Hospital of Rhode Island
  Purpose
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.

Condition Intervention
Hypertension Cardiovascular Disease Behavioral: HBPM+website+patient navigator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Pilot Study of Home Blood Pressure Control Program (eBP Control)

Further study details as provided by Charles B. Eaton, Memorial Hospital of Rhode Island:

Primary Outcome Measures:
  • Percent of patients at BP goal [ Time Frame: Nine months ]
    Percentage of patients at systolic and/or diastolic blood pressure at goal at the fourth research visit (end of the study)


Secondary Outcome Measures:
  • Health status [ Time Frame: Nine Months ]
    SF-12 questionnaire, patient activation

  • Use of intervention tools [ Time Frame: Nine months ]
    home blood pressure monitor-amount of time at goal; number of times patient utilized the website

  • Costs [ Time Frame: Nine months ]

Enrollment: 28
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: HBPM only
Experimental: HBPM+website+patient navigator 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

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed w/ hypertension or elevated blood pressure, uncontrolled blood pressure at the baseline research visit according to the following risk levels:

    • Average risk,
    • SBP >140 mmHg or DBP > 90 mmHg;
  • 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:

  • Unable to comply with protocol;
  • pregnancy;
  • secondary hypertension (e.g. renovascular);
  • participation in other hypertension clinical trials;
  • hospitalized in the past six months for diabetes, renal failure, or heart failure;
  • severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min);
  • patient already routinely using a home blood pressure monitoring device or patient not able to use HBPM device due to disability;
  • arm circumference larger than 17 inches determined during telephone screener,
  • arm circumference smaller than 9 inches measured at baseline research visit.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387945


Locations
United States, Rhode Island
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
Sponsors and Collaborators
Memorial Hospital of Rhode Island
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Charles B Eaton, MD Memorial Hospital of Rhode Island
  More Information

Responsible Party: Charles B. Eaton, Director of Center for Primary Care and Prevention, Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01387945     History of Changes
Other Study ID Numbers: NCT 01242319
1R21HS018238-01 ( U.S. AHRQ Grant/Contract )
First Submitted: July 1, 2011
First Posted: July 6, 2011
Last Update Posted: April 4, 2016
Last Verified: March 2016

Keywords provided by Charles B. Eaton, Memorial Hospital of Rhode Island:
Home blood pressure monitoring
Patient activation
Patient-centered care
Community Health Aides
Primary Health Care

Additional relevant MeSH terms:
Cardiovascular Diseases