Coronary Heart DiseasePhase 2NCT00127751
Heart Disease on the Mend
A Phase 2 study testing Enhance health lifestyle changes and medication compliance in people with Coronary Heart Disease and Stroke, run by Stanford University at 1 site in United States.
Trial summary
The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Coronary Heart Disease, Stroke, Hyperlipidemia
- What is being tested?
- Enhance health lifestyle changes and medication compliance
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to May 2003
- Phase
- Phase 2
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 35 years
- One or more major risk factors
- Live in Santa Clara County
- Low family income that limits access to medical care
Who cannot join
- Under active medical treatment for cancer, CVD or other major medical disorder
- Reasonable access to health care
- Under 35 years of age
- Not a resident of Santa Clara County
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients
The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life.
Read the detailed description
The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life. Subjects were primarily recruited from patients being seen in free medical clinics in Santa Clara County California. Primary eligibility was ≥ 35 years of age, one or more CVD risk factors (with or without clinical CVD), low family income, and residing in Santa Clara County. Patients in the case management group were provided counseling services by specially trained registered nurses (RNs) and registered dieticians (RDs) and assisted in obtaining medications and medical services from programs provided in the county or indigent drug programs provided by selected pharmaceutical companies. Protocol driven treatment algorithms based on national practice guidelines were used and use of existing programs and resources were maximized. On average patients in case management were seen by staff 6-9 in the 12 months.
- Conditions
- Coronary Heart Disease, Stroke, Hyperlipidemia, Hypertension
- Being tested
- Enhance health lifestyle changes and medication compliance
- Keywords
- Risk factor reduction, cardiovascular disease prevention
- Medical subject headings
- Coronary Disease, Stroke, Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhance health lifestyle changes and medication complianceBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease risk score
Low-density lipoprotein (LDL)-cholesterol
Systolic blood pressure
Secondary outcomes (3)
Body mass index (BMI)
Physical activity score
Nutrition score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startMay 2000
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- The Health Trust of Santa Clara County
- Investigators
- William L Haskell, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127751
- Sponsor's protocol ID
- 373765
- Status last verified
- Aug 2005
- First submitted
- 5 Aug 2005
- Last updated
- 25 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cardiovascular Disease Multifactor Risk Reduction Program for Medically Underserved High-Risk Patients
- ClinicalTrials.gov ID
- NCT00127751
- Acronym / sponsor ID
- 373765
- Conditions
- Coronary Heart Disease, Stroke, Hyperlipidemia, Hypertension
- Keywords
- Risk factor reduction, cardiovascular disease prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- The Health Trust of Santa Clara County
- Study start
- May 2000
- Study completion
- May 2003
- First posted
- 8 Aug 2005 (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 primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life.
Detailed description
The primary objective of this study was to evaluate the effectiveness of a multifactor cardiovascular disease (CVD) risk reduction program using team case management in high risk patients who have low family incomes and limited access to medical care. Patients were randomized to case management (99) or usual care (49) with baseline, 6-month and 12-month evaluations of CVD risk factors, clinical status and quality of life. Subjects were primarily recruited from patients being seen in free medical clinics in Santa Clara County California. Primary eligibility was ≥ 35 years of age, one or more CVD risk factors (with or without clinical CVD), low family income, and residing in Santa Clara County. Patients in the case management group were provided counseling services by specially trained registered nurses (RNs) and registered dieticians (RDs) and assisted in obtaining medications and medical services from programs provided in the county or indigent drug programs provided by selected pharmaceutical companies. Protocol driven treatment algorithms based on national practice guidelines were used and use of existing programs and resources were maximized. On average patients in case management were seen by staff 6-9 in the 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women ≥ 35 years
- One or more major risk factors
- Live in Santa Clara County
- Low family income that limits access to medical care
Key exclusion criteria (4 listed)
- Under active medical treatment for cancer, CVD or other major medical disorder
- Reasonable access to health care
- Under 35 years of age
- Not a resident of Santa Clara County
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 |
|---|---|---|
| Enhance health lifestyle changes and medication compliance | Behavioural | – |
Primary outcome
Cardiovascular disease risk score
Low-density lipoprotein (LDL)-cholesterol
Systolic blood pressure
3 secondary outcomes
Body mass index (BMI)
Physical activity score
Nutrition score
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 25 Aug 2005.
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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.
William L Haskell, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enhance health lifestyle changes and medication compliance in people with Coronary Heart Disease and Stroke, run by Stanford University 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 4 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 25 Aug 2005. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiovascular disease risk score. The study lists 3 primary outcomes in all. 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 25 Aug 2005.