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

NCT ID: NCT01387945

Last Updated: 2016-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-09-30

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.

Conditions

Hypertension; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

HBPM only

Group Type: NO_INTERVENTION

No interventions assigned to this group

HBPM+website+patient navigator

Group Type: EXPERIMENTAL

HBPM+website+patient navigator

Intervention Type: BEHAVIORAL

In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator.

Interventions

HBPM+website+patient navigator

In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator.

Intervention Type: BEHAVIORAL

Other Intervention Names

Good Health Gateway

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Memorial Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Charles B. Eaton

Director of Center for Primary Care and Prevention

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles B Eaton, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Hospital of Rhode Island

Locations

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, United States

Countries

United States

Other Identifiers

1R21HS018238-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

NCT 01242319

Identifier Type: -

Identifier Source: org_study_id