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

July 1, 2011
July 15, 2011
September 2010
May 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01387945 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Pilot Study of Home Blood Pressure Control Program
E-health BP Control Program

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
  • Hypertension
  • Cardiovascular Disease
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
  • No Intervention: HBPM only
  • Experimental: HBPM+website+patient navigator
    Intervention: Behavioral: HBPM+website+patient navigator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2012
May 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact: Charles B Eaton, MD, MS 401-729-2625 charles_eaton@mhri.org
United States
 
NCT01387945
NCT01242319, 1R21HS018238-01
No
Charles B. Eaton MD, Memorial Hospital of Rhode Island
Memorial Hospital of Rhode Island
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Charles B Eaton, MD Memorial Hospital of Rhode Island
Memorial Hospital of Rhode Island
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP