NCT01387945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

July 1, 2011

Last Update Submit

March 31, 2016

Conditions

HypertensionCardiovascular Disease

Keywords

Home blood pressure monitoringPatient activationPatient-centered careCommunity Health AidesPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Health status

    Nine Months

  • Use of intervention tools

    Nine months

  • Costs

    Nine months

Study Arms (2)

HBPM only

NO INTERVENTION

HBPM+website+patient navigator

EXPERIMENTAL
Behavioral: HBPM+website+patient navigator

Interventions

HBPM+website+patient navigatorBEHAVIORAL

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

Also known as: Good Health Gateway
HBPM+website+patient navigator

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

MeSH Terms

Conditions

HypertensionCardiovascular DiseasesPatient Participation

Condition Hierarchy (Ancestors)

Vascular DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Charles B Eaton, MD

    Memorial Hospital of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center for Primary Care and Prevention

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 6, 2011

Study Start

September 1, 2010

Primary Completion

May 1, 2012

Study Completion

September 1, 2012

Last Updated

April 4, 2016

Record last verified: 2016-03

Locations

US(1)