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

Hypertension Clinical Trial

— eBPcontrol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387945
• Other study ID #: NCT 01242319
• Secondary ID: 1R21HS018238-01
• Status: Completed
• Phase: N/A
• First received: July 1, 2011
• Last updated: March 31, 2016
• Start date: September 2010
• Est. completion date: September 2012

Study information

• Verified date: March 2016
• Source: Memorial Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension

Intervention

Behavioral:
• HBPM+website+patient navigator
In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator.

Locations

Country	Name	City	State
United States	Memorial Hospital of Rhode Island	Pawtucket	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Hospital of Rhode Island	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Health status	SF-12 questionnaire, patient activation	Nine Months	No
Secondary	Use of intervention tools	home blood pressure monitor-amount of time at goal; number of times patient utilized the website	Nine months	No
Secondary	Costs		Nine months	No