HypertensionPhase 1NCT00291824
Cardiovascular Lifestyle Study: Effects and Expense of a Cardiovascular Risk Reduction Clinic in Primary Care
A Phase 1 study testing Cardiovascular risk factors and willingness to change in people with Hypertension and Hyperlipidemia, run by Caroline Medical Group at 1 site in Canada.
Trial summary
The purpose of this trial is to study the effects on risk reduction and expense of 3 approaches to the care of people with cardiovascular risk factors in a naturalistic primary care environment. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Hypertension, Hyperlipidemia, Hyperglycemia
- What is being tested?
- Cardiovascular risk factors and willingness to change
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 670 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2004to Feb 2006
- Phase
- Phase 1
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A random sample of all persons with visits to their primary care physician for cardiovascular risks in past year. Cognitively intact (mini-mental state) or living with a carer who is cognitively intact. All other co-morbidities
Who cannot join
- Presently in a nursing home or in-patient long-term care facility (already receiving medications and diets as prescribed). No available family/friend interpreter if non-English speaking.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Caroline Medical Group
Burlington, Ontario, L7R4C7
Michael Mills, MD CCFP
Donna Landry, 905.632.8007 ext. 103
About this study
Official title: A Randomized Controlled Trial of the Effects and Expense of a Primary and Secondary Cardiovascular Risk Reduction Clinic in Primary Care
The purpose of this trial is to study the effects on risk reduction and expense of 3 approaches to the care of people with cardiovascular risk factors in a naturalistic primary care environment.
Read the detailed description
Background: Uncontrolled hypertension, hyperlipidemia, hyperglycemia, smoking and other cardiovascular risks remain at epidemic proportions despite known efficacious treatments. Issues of both provider and patient behavioral non-adherence to guidelines and therapeutic regimes, respectively, are key factors in non-control. Few interventions aimed at reducing cardiovascular risk factors are based on sound theories of behavior change.
Objective: To assess the effectiveness and expense of three approaches to the care of persons with known risks for cardiovascular disease. The three treatment approaches are usual care, usual care plus nurse telephone calls, and usual care plus clinic visits to a nurse and/or physician.
Design: Patients will be randomized to a 1) specialized proactive, and holistic cardiovascular risk management clinic using principles of behavior change; 2) nurse telephone calls as an attention placebo, yet a low dose, health promotion intervention; and 3) usual primary care. A random sample of 670 patients with cardiovascular risks identified in the past five years will be selected. Patients will be excluded if they do not speak English, are cognitively impaired or live in a nursing home. Interview questionnaires will measure cardiovascular risk, intention to change, social support, depression, coping and health services use. In addition, patients will be required to give a blood sample to measure cholesterol and glucose levels. Patients will then be randomized to one of three treatment groups.
Significance: The expected findings of this study is that the cardiovascular clinic, with nurse and physician, will be most effective at reducing cardiovascular risk and will pay for itself by averting hospital and emergency use for cardiovascular events.
- Conditions
- Hypertension, Hyperlipidemia, Hyperglycemia, Cardiovascular Disease, Smoking
- Being tested
- Cardiovascular risk factors and willingness to change
- Keywords
- Cardiovascular risks, Motivational interviewing, Behavior change, Primary care setting
- Medical subject headings
- Hypertension, Hyperlipidemias, Hyperglycemia, Cardiovascular Diseases, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular risk factors and willingness to changeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Current Interview or Chart
International classification of diseases
Characteristics/demographics (dob, gender, marital status, living arrangement, employment, culture, language, spiritual beliefs, concurrent diseases - number/type).
Cognition: 10 item short portable mental status questionnaire (SPMSQ)(Pfeiffer, 1975)
Number of MD visits for cardiovascular risk factor
Percentage change in cardiovascular risk scores over time.
Percentage of targeted weight and exercise goals achieved (blood pressure control, smoking cessation, weight control, cholesterol control, sugar control, exercise levels). (Grundy, et al, 1999)
Self efficacy scale (Lorig et al, 1996)
Social support - personal resource questionnaire 85 (Weinert & Brandt 1987).
Depression (MADRS)(Montgomery & Asberg 1979) (Montgomery et al 1985) (Browne, Steiner Roberts et al 2002).
Coping (Moos and Billings 1984)
Expenditures of health and social services (Browne et al 2001)
Calculate the number of Framingham points for each risk factor
Blood samples
Counselling
Education
Secondary outcomes (2)
Motivational Interviewing
Behavior Change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startAug 2004
- Study completionFeb 2006
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 670 participants
Sponsor and investigators
- Lead sponsor
- Caroline Medical Group
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada
- Investigators
- Michael Mills, MD CCFP, Principal investigator, Caroline Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291824
- Sponsor's protocol ID
- PHCTF G03-02656
- Status last verified
- Feb 2006
- First submitted
- 13 Feb 2006
- Last updated
- 15 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Effects and Expense of a Primary and Secondary Cardiovascular Risk Reduction Clinic in Primary Care
- ClinicalTrials.gov ID
- NCT00291824
- Acronym / sponsor ID
- PHCTF G03-02656
- Conditions
- Hypertension, Hyperlipidemia, Hyperglycemia, Cardiovascular Disease, Smoking
- Keywords
- Cardiovascular risks, Motivational interviewing, Behavior change, Primary care setting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 670 participants
- Lead sponsor
- Caroline Medical GroupUniversity, hospital or other
- Collaborators
- Health Canada
- Study start
- Aug 2004
- Study completion
- Feb 2006
- First posted
- 15 Feb 2006 (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 effects on risk reduction and expense of 3 approaches to the care of people with cardiovascular risk factors in a naturalistic primary care environment.
Detailed description
Background: Uncontrolled hypertension, hyperlipidemia, hyperglycemia, smoking and other cardiovascular risks remain at epidemic proportions despite known efficacious treatments. Issues of both provider and patient behavioral non-adherence to guidelines and therapeutic regimes, respectively, are key factors in non-control. Few interventions aimed at reducing cardiovascular risk factors are based on sound theories of behavior change.
Objective: To assess the effectiveness and expense of three approaches to the care of persons with known risks for cardiovascular disease. The three treatment approaches are usual care, usual care plus nurse telephone calls, and usual care plus clinic visits to a nurse and/or physician.
Design: Patients will be randomized to a 1) specialized proactive, and holistic cardiovascular risk management clinic using principles of behavior change; 2) nurse telephone calls as an attention placebo, yet a low dose, health promotion intervention; and 3) usual primary care. A random sample of 670 patients with cardiovascular risks identified in the past five years will be selected. Patients will be excluded if they do not speak English, are cognitively impaired or live in a nursing home. Interview questionnaires will measure cardiovascular risk, intention to change, social support, depression, coping and health services use. In addition, patients will be required to give a blood sample to measure cholesterol and glucose levels. Patients will then be randomized to one of three treatment groups.
Significance: The expected findings of this study is that the cardiovascular clinic, with nurse and physician, will be most effective at reducing cardiovascular risk and will pay for itself by averting hospital and emergency use for cardiovascular events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- A random sample of all persons with visits to their primary care physician for cardiovascular risks in past year. Cognitively intact (mini-mental state) or living with a carer who is cognitively intact. All other co-morbidities
Key exclusion criteria (1 listed)
- Presently in a nursing home or in-patient long-term care facility (already receiving medications and diets as prescribed). No available family/friend interpreter if non-English speaking.
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 |
|---|---|---|
| Cardiovascular risk factors and willingness to change | Behavioural | – |
Primary outcome
Current Interview or Chart
International classification of diseases
Characteristics/demographics (dob, gender, marital status, living arrangement, employment, culture, language, spiritual beliefs, concurrent diseases - number/type).
Cognition: 10 item short portable mental status questionnaire (SPMSQ)(Pfeiffer, 1975)
Number of MD visits for cardiovascular risk factor
Percentage change in cardiovascular risk scores over time.
Percentage of targeted weight and exercise goals achieved (blood pressure control, smoking cessation, weight control, cholesterol control, sugar control, exercise levels). (Grundy, et al, 1999)
Self efficacy scale (Lorig et al, 1996)
Social support - personal resource questionnaire 85 (Weinert & Brandt 1987).
Depression (MADRS)(Montgomery & Asberg 1979) (Montgomery et al 1985) (Browne, Steiner Roberts et al 2002).
Coping (Moos and Billings 1984)
Expenditures of health and social services (Browne et al 2001)
Calculate the number of Framingham points for each risk factor
Blood samples
Counselling
Education
2 secondary outcomes
Motivational Interviewing
Behavior Change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2006.
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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.
Michael Mills, MD CCFP principal investigator
Caroline Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cardiovascular risk factors and willingness to change in people with Hypertension and Hyperlipidemia, run by Caroline Medical Group at 1 site in Canada.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Feb 2006. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Mills, MD (905.632.8007, mmills@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Current Interview or Chart. The study lists 16 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 15 Feb 2006; AzTrials last refreshed its copy on 7 Nov 2026.