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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Cardiovascular Disease
• Intervention / Treatment: Behavioral: HBPM+website+patient navigator

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Memorial Hospital of Rhode Island

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Good Health Gateway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Nine months
Costs		Nine months

Collaborators and Investigators

• Sponsor: Memorial Hospital of Rhode Island
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Charles B Eaton, MD, Memorial Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 1, 2011
• First Submitted That Met QC Criteria: July 5, 2011
• First Posted (Estimate): July 6, 2011

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 31, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Primary Health Care; Patient-centered care; Home blood pressure monitoring; Patient activation; Community Health Aides
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: NCT 01242319; 1R21HS018238-01 (U.S. AHRQ Grant/Contract)