HypertensionHBPMNCT01162759
Home Blood Pressure Monitoring Project
A study testing Home Blood Pressure Monitoring in people with Hypertension, run by Kaiser Permanente at 1 site in United States.
Trial summary
The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Home Blood Pressure Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jul 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 85 years At least 1 diagnosis for hypertension,
- Receive primary care from one of the participating clinics,
- The two most recent BPs documented within that last 24 months are elevated (SBP>140 and/or DBP>90)
- Receiving < 3 antihypertensive medications, and
- Have access to a computer with a USB port.
Who cannot join
- Pregnant, or breast-feeding,
- Patients on dialysis or being followed by nephrology,
- Patients with coronary artery disease, given these patients are already followed by the Clinical Pharmacy Cardiac Risk Service (CPCRS),
- On KPCO "Do Not Call" or deceased list,
- PCP does not give permission to include patient in the study,
- BP is at or below target at the baseline study visit,
- Not English-speaking.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Colorado, Institute of Health Research
Denver, Colorado, 80231
About this study
Official title: Home Blood Pressure Monitoring Program
The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and multidisciplinary care team. Participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving Kaiser standard of care. We will determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines. The study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (HBPM) group will achieve their target blood pressure compared to those in the usual care (UC) group.
Read the detailed description
STUDY OBJECTIVES:
Primary:
- To determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines
Secondary:
The following parameters will be evaluated between groups:
- Change in BP measures between baseline and at 6 months
- Proportion of patients who are receiving antihypertensive treatments in accordance to national clinical practice guidelines
- Adherence to hypertensive medication regimen during the 6-month follow-up period
- Patient satisfaction with the care model.
- Conditions
- Hypertension
- Being tested
- Home Blood Pressure Monitoring
- Keywords
- hypertension, intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Blood Pressure MonitoringBehavioural
Also called HBPM
Home blood pressure readings are taken at least 3 times a week, uploaded to a Microsoft Health Vault account through American Heart Association Heart360 at least 1 time per week. Patients are followed by a clinical pharmacist, with physician oversight, who will make adjustments to antihypertensive medications or suggest additional medications using national JNC VII and KPCO hypertension guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | The control group receiving usual care |
| Home Blood Pressure Monitoring Group | Experimental | Intervention group Receives: Behavioral: Home Blood Pressure Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
BP at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startJul 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- David J Magid, MD, MPH, Principal investigator, Kaiser PermanenteKari Olson, PharmD, Principal investigator, Kaiser PermanenteSarah J Billups, PharmD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162759
- Sponsor's protocol ID
- CO-08DMagi-01
- Acronym
- HBPM
- Status last verified
- Apr 2012
- First submitted
- 13 Jul 2010
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):157-63. doi: 10.1161/CIRCOUTCOMES.112.968172. Epub 2013 Mar 5.
PubMed 23463811
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Blood Pressure Monitoring Program
- ClinicalTrials.gov ID
- NCT01162759
- Acronym / sponsor ID
- HBPM / CO-08DMagi-01
- Conditions
- Hypertension
- Keywords
- hypertension, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 15 Jul 2010 (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.
The goal of this project is to improve hypertension control at Kaiser Permanente Colorado (KPCO) by implementing a population-based multi-factorial intervention that uses home BP monitors that can download BP readings to KPCO's health records via internet, interactive voice response (IVR) technology, and multidisciplinary care team. Participants will be randomized to either the home blood pressure monitoring group receiving the multi-factorial intervention or the usual care group who will be receiving Kaiser standard of care. We will determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines. The study hypothesis is that a higher proportion of patients with uncontrolled hypertension in the home blood pressure monitoring (HBPM) group will achieve their target blood pressure compared to those in the usual care (UC) group.
Detailed description
STUDY OBJECTIVES:
Primary:
- To determine the proportion of patients in each group who achieve their target BP goals at 6 months, according to national clinical practice guidelines
Secondary:
The following parameters will be evaluated between groups:
- Change in BP measures between baseline and at 6 months
- Proportion of patients who are receiving antihypertensive treatments in accordance to national clinical practice guidelines
- Adherence to hypertensive medication regimen during the 6-month follow-up period
- Patient satisfaction with the care model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –The control group receiving usual care |
| Home Blood Pressure Monitoring Group | Experimental | Behavioral: Home Blood Pressure MonitoringIntervention group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 85 years At least 1 diagnosis for hypertension,
Key exclusion criteria (7 listed)
- Pregnant, or breast-feeding,
- Patients on dialysis or being followed by nephrology,
- Patients with coronary artery disease, given these patients are already followed by the Clinical Pharmacy Cardiac Risk Service (CPCRS),
- On KPCO "Do Not Call" or deceased list,
- PCP does not give permission to include patient in the study,
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 |
|---|---|---|
| Home Blood Pressure MonitoringAlso: HBPMHome blood pressure readings are taken at least 3 times a week, uploaded to a Microsoft Health Vault account through American Heart Association Heart360 at least 1 time per week. Patients are followed by a clinical pharmacist, with physician oversight, who will make adjustments to antihypertensive medications or suggest additional medications using national JNC VII and KPCO hypertension guidelines. | Behavioural | Home Blood Pressure Monitoring Group |
Primary outcome
BP at 6 months
Time frame: 6 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 6 Apr 2012.
- Derived from this study: PubMed 23463811Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. A pharmacist-led, American Heart Association Heart360 Web-enabled home blood pressure monitoring program. Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):157-63. doi: 10.1161/CIRCOUTCOMES.112.968172. Epub 2013 Mar 5.
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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.
David J Magid, MD, MPH principal investigator
Kaiser Permanente
Kari Olson, PharmD principal investigator
Kaiser Permanente
Sarah J Billups, PharmD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Blood Pressure Monitoring in people with Hypertension, run by Kaiser Permanente 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 5 inclusion and 7 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 6 Apr 2012. 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?
BP at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01162759, which also lists 1 linked publication.
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 6 Apr 2012.