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Completed

NCT Number: NCT01387945

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HBPM+website+patient navigator

Behavioral

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

Other names: Good Health Gateway

Primary outcomes

  1. Percent of patients at BP goal

    Time frame: Nine months

    Percentage of patients at systolic and/or diastolic blood pressure at goal at the fourth research visit (end of the study)

Secondary outcomes

  1. Health status

    Time frame: Nine Months

    SF-12 questionnaire, patient activation

  2. Use of intervention tools

    Time frame: Nine months

    home blood pressure monitor-amount of time at goal; number of times patient utilized the website

  3. Costs

    Time frame: Nine months

Sponsors and collaborators

Lead sponsor

Memorial Hospital of Rhode Island

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: eBPcontrol

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 6, 2011
Registry last updated
Apr 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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