Clinical trial NCT01387945: Pilot Study of Home Blood Pressure Control Program (eBP Control)
Official title: Pilot Study of Home Blood Pressure Control Program (eBP Control)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Disease
Keywords: Home blood pressure monitoring
Patient activation
Patient-centered care
Community Health Aides
Primary Health Care
Lead sponsor: Memorial Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2011-07-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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.

Primary outcomes:
measure: Percent of patients at BP goal
timeFrame: Nine months
Secondary outcomes:
measure: Health status
timeFrame: Nine Months
measure: Use of intervention tools
timeFrame: Nine months
measure: Costs
timeFrame: Nine months
Other outcomes:
Locations:
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Memorial Hospital of Rhode Island
name: Charles B Eaton, MD
role: PRINCIPAL_INVESTIGATOR
References: