Pilot Study of Home Blood Pressure Control Program (eBPcontrol)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Memorial Hospital of Rhode Island.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT01387945
First received: July 1, 2011
Last updated: July 15, 2011
Last verified: June 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: E-health BP Control Program

Resource links provided by NLM:


Further study details as provided by Memorial Hospital of Rhode Island:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Health status [ Time Frame: Nine Months ] [ Designated as safety issue: No ]
    SF-12 questionnaire, patient activation

  • Use of intervention tools [ Time Frame: Nine months ] [ Designated as safety issue: No ]
    home blood pressure monitor-amount of time at goal; number of times patient utilized the website

  • Costs [ Time Frame: Nine months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: July 2012
Estimated 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387945

Contacts
Contact: Charles B Eaton, MD, MS 401-729-2625 charles_eaton@mhri.org

Locations
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Charles B Eaton, MD, MS    401-729-2625    charles_eaton@mhri.org   
Principal Investigator: Charles B Eaton, MD, MS         
Sponsors and Collaborators
Memorial Hospital of Rhode Island
Investigators
Principal Investigator: Charles B Eaton, MD Memorial Hospital of Rhode Island
  More Information

No publications provided

Responsible Party: Charles B. Eaton MD, Memorial Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT01387945     History of Changes
Other Study ID Numbers: NCT01242319, 1R21HS018238-01
Study First Received: July 1, 2011
Last Updated: July 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Hypertension
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014