HypertensioneBPcontrolNCT01387945
Pilot Study of Home Blood Pressure Control Program (eBP Control)
A study testing HBPM+website+patient navigator in people with Hypertension and Cardiovascular Disease, run by Memorial Hospital of Rhode Island at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension, Cardiovascular Disease
- What is being tested?
- HBPM+website+patient navigator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860
About this study
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.
Read the 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
- Being tested
- HBPM+website+patient navigator
- Keywords
- Home blood pressure monitoring, Patient activation, Patient-centered care, Community Health Aides, Primary Health Care
- Medical subject headings
- Hypertension, Cardiovascular Diseases, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBPM+website+patient navigatorBehavioural
Also called Good Health Gateway
In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator.
| Study group | Role | What they receive |
|---|---|---|
| HBPM only | No intervention | Not described |
| HBPM+website+patient navigator | Experimental | Not described Receives: Behavioral: HBPM+website+patient navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Nine months
Secondary outcomes (3)
Health status
SF-12 questionnaire, patient activation
Measured: Nine Months
Use of intervention tools
home blood pressure monitor-amount of time at goal; number of times patient utilized the website
Measured: Nine months
Costs
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Charles B. Eaton, Memorial Hospital of Rhode Island
- Investigators
- Charles B Eaton, MD, Principal investigator, Memorial Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387945
- Sponsor's protocol ID
- NCT 01242319
- Other IDs
- 1R21HS018238-01
- Acronym
- eBPcontrol
- Status last verified
- Mar 2016
- First submitted
- 1 Jul 2011
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Home Blood Pressure Control Program (eBP Control)
- ClinicalTrials.gov ID
- NCT01387945
- Acronym / sponsor ID
- eBPcontrol / NCT 01242319
- Conditions
- Hypertension, Cardiovascular Disease
- Keywords
- Home blood pressure monitoring, Patient activation, Patient-centered care, Community Health Aides, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Memorial Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Sep 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBPM only | No intervention | – |
| HBPM+website+patient navigator | Experimental | Behavioral: HBPM+website+patient navigator |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed w/ hypertension or elevated blood pressure, uncontrolled blood pressure at the baseline research visit according to the following risk levels:
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBPM+website+patient navigatorAlso: Good Health GatewayIn addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator. | Behavioural | HBPM+website+patient navigator |
Primary outcome
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)
3 secondary outcomes
Health status
Time frame: Nine Months
Use of intervention tools
Time frame: Nine months
Costs
Time frame: Nine months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles B Eaton, MD principal investigator
Memorial Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBPM+website+patient navigator in people with Hypertension and Cardiovascular Disease, run by Memorial Hospital of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients at BP goal (time frame: Nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2016.