HypertensionNCT00523536
Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk
A study testing Patient Navigator - Nurse Team Intervention in people with Hypertension, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
The purpose of this trial is to study the effect of a patient navigator-nurse team in improving the management of hypertension and other cardiovascular disease risk factors in a health care system taking care of a vulnerable, mostly Latino population. Read more about this study
- Who is it for?
- Ages 21 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Patient Navigator - Nurse Team Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Aug 2009
- 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 21 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active patients from the Target Adult Health Clinic
- Identified with a diagnosis of hypertension
- Uncontrolled hypertension (2 of 3 last BP measurements above target BP range; target BP is defined at 140/90 or 130/80 mm Hg for people with diabetes or kidney disease)
Who cannot join
- Pregnant or breastfeeding
- End-stage kidney disease requiring dialysis
- Co-morbid illness with life expectancy less than 12 months
- Institutionalized individuals because of the potentially confounding factors due to severe co-morbidity or other medical conditions
Trial locations and contacts
1 site in 1 country.
United States1 site
East Adult Clinic, Denver Health
Denver, Colorado, 80204
About this study
Official title: Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Evaluation of a Navigator-Nurse Care Team on Hypertension and Cardiovascular Disease Risk
The purpose of this trial is to study the effect of a patient navigator-nurse team in improving the management of hypertension and other cardiovascular disease risk factors in a health care system taking care of a vulnerable, mostly Latino population.
Read the detailed description
This study represents one phase of a large partnership grant with The Colorado Health Outcomes Program of the University of Colorado at Denver Health Sciences Center (UCDHSC) and Denver Health and Hospital Authority (DH). The overarching goal of Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR) is to improve the primary and secondary prevention of cardiovascular disease (CVD) in Hispanics through a comprehensive research program aimed at (1) increasing awareness of CVD risk in the Hispanic community and increasing participation of high risk Hispanics in the health care system, (2) developing more effective models of care delivery for high risk patients in a health system, and (3) identifying markers that will more effectively identify Hispanic patients at high risk of CVD than current approaches based on traditional risk factors.
This trial has been designed to assess the effectiveness of a quality improvement project which focuses on the hypertensive multiracial underserved population within the Denver Health system. In addition, we are hoping at study end to have developed and validate this project as an efficient and sustainable approach to improving blood pressure control and controlling cardiovascular risk factors, especially in the vulnerable patient population served at Denver Health.
The objective of this quality improvement program is to conduct a randomized, primary care-based, efficacy trial evaluating the effectiveness of a patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors using information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study is designed to test the hypothesis that a patient navigator-nurse assisted intervention will improve blood pressure (BP) in vulnerable hypertensive patients, compared with usual clinical care.
- Conditions
- Hypertension
- Being tested
- Patient Navigator - Nurse Team Intervention
- Keywords
- High Blood Pressure, Cardiovascular
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Navigator - Nurse Team InterventionBehavioural
The patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors will use information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study will test the effect of this intervention on blood pressure control and utilization of hospital services in adult patients with hypertension.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patient navigator-nurse disease management intervention Receives: Behavioral: Patient Navigator - Nurse Team Intervention |
| 2 | No intervention | Usual clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SBP level
Measured: Measured at Year 1
Secondary outcomes (2)
Percentage of participants with BP control by JNC-7 guidelines, adherence with BP medications, lipid control, change of HgbA1c for participants with diabetes, and change in smoking status/BMI
Measured: Measured at Year 1
Utilization of urgent care visits/emergency department/hospitalizations
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2009
- Study completionAug 2009
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ed Havranek, Denver Health and Hospital Authority
- Investigators
- Raymond O. Estacio, MD, Principal investigator, Denver Health, University of Colorado at Denver Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523536
- Sponsor's protocol ID
- 486
- Other IDs
- U01HL079160, U01HL079160-03
- Status last verified
- Apr 2009
- First submitted
- 30 Aug 2007
- Last updated
- 2 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Evaluation of a Navigator-Nurse Care Team on Hypertension and Cardiovascular Disease Risk
- ClinicalTrials.gov ID
- NCT00523536
- Acronym / sponsor ID
- 486
- Conditions
- Hypertension
- Keywords
- High Blood Pressure, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver
- Study start
- May 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 31 Aug 2007 (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 purpose of this trial is to study the effect of a patient navigator-nurse team in improving the management of hypertension and other cardiovascular disease risk factors in a health care system taking care of a vulnerable, mostly Latino population.
Detailed description
This study represents one phase of a large partnership grant with The Colorado Health Outcomes Program of the University of Colorado at Denver Health Sciences Center (UCDHSC) and Denver Health and Hospital Authority (DH). The overarching goal of Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR) is to improve the primary and secondary prevention of cardiovascular disease (CVD) in Hispanics through a comprehensive research program aimed at (1) increasing awareness of CVD risk in the Hispanic community and increasing participation of high risk Hispanics in the health care system, (2) developing more effective models of care delivery for high risk patients in a health system, and (3) identifying markers that will more effectively identify Hispanic patients at high risk of CVD than current approaches based on traditional risk factors.
This trial has been designed to assess the effectiveness of a quality improvement project which focuses on the hypertensive multiracial underserved population within the Denver Health system. In addition, we are hoping at study end to have developed and validate this project as an efficient and sustainable approach to improving blood pressure control and controlling cardiovascular risk factors, especially in the vulnerable patient population served at Denver Health.
The objective of this quality improvement program is to conduct a randomized, primary care-based, efficacy trial evaluating the effectiveness of a patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors using information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study is designed to test the hypothesis that a patient navigator-nurse assisted intervention will improve blood pressure (BP) in vulnerable hypertensive patients, compared with usual clinical care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Patient Navigator - Nurse Team InterventionPatient navigator-nurse disease management intervention |
| 2 | No intervention | –Usual clinical care |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active patients from the Target Adult Health Clinic
- Identified with a diagnosis of hypertension
- Uncontrolled hypertension (2 of 3 last BP measurements above target BP range; target BP is defined at 140/90 or 130/80 mm Hg for people with diabetes or kidney disease)
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding
- End-stage kidney disease requiring dialysis
- Co-morbid illness with life expectancy less than 12 months
- Institutionalized individuals because of the potentially confounding factors due to severe co-morbidity or other medical conditions
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 |
|---|---|---|
| Patient Navigator - Nurse Team InterventionThe patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors will use information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study will test the effect of this intervention on blood pressure control and utilization of hospital services in adult patients with hypertension. | Behavioural | 1 |
Primary outcome
Change in SBP level
Time frame: Measured at Year 1
2 secondary outcomes
Percentage of participants with BP control by JNC-7 guidelines, adherence with BP medications, lipid control, change of HgbA1c for participants with diabetes, and change in smoking status/BMI
Time frame: Measured at Year 1
Utilization of urgent care visits/emergency department/hospitalizations
Time frame: Measured at Year 1
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 2 Sep 2013.
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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.
Raymond O. Estacio, MD principal investigator
Denver Health, University of Colorado at Denver Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigator - Nurse Team Intervention in people with Hypertension, run by Denver Health and Hospital Authority 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 3 inclusion and 4 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 2 Sep 2013. 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?
Change in SBP level (time frame: Measured at Year 1). 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 2 Sep 2013.