Cardiovascular DiseasesU-CHAMPNCT00626041
U-CHAMP: Urban Cardiovascular Health Assessment and Management Program
A study testing participant referral to primary care network physician in people with Cardiovascular Diseases and Hypertension, run by University of Calgary at 2 sites in Canada.
Trial summary
High blood pressure, elevated blood glucose and high cholesterol are related to the increased risk of stroke and heart disease. Many studies have shown that this risk can be significantly reduced by lowering blood pressure, blood glucose and cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Hyperlipidemia
- What is being tested?
- participant referral to primary care network physician
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2008to Jun 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18-85 years
- Signed consent
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 1 recruiting
- Recruiting
Calgary Safeway Pharmacy - Crowfoot Location
Calgary, Alberta, T3G 2L4
Rita Bowron, BScPharm, 403-831-6987
Charlotte A Jones, PhD MD
- Terminated
Coop Pharmacy - Crowfoot Location
Calgary, Alberta, T3G 2L5
About this study
High blood pressure, elevated blood glucose and high cholesterol are related to the increased risk of stroke and heart disease. Many studies have shown that this risk can be significantly reduced by lowering blood pressure, blood glucose and cholesterol levels.
Through a collaborative effort between Calgary Safeway pharmacists and Calgary Health Region family physician PCN's, U-CHAMP will deliver a program to assist in the identification and management of people with elevated blood pressure, blood glucose and cholesterol and through this effort, reduce the risk of heart disease and stroke in the urban Calgary population aged 18-85 years.
Read the detailed description
Hypertension (HBP) has long been correlated with risk of stroke and other adverse cardiovascular outcomes. Randomized controlled trials of blood pressure lowering have demonstrated at least 30% reductions in stroke incidence and improved mortality. Despite being such a readily modifiable risk, HBP remains under diagnosed and under treated. To address this gap, the A-CHAMP (Airdrie Community Hypertension Awareness and Management Program) was successfully piloted in Airdrie, a community of 20,000 north of Calgary, Alberta. Trained volunteers held BP screening sessions for seniors in local pharmacies and referred hypertensive participants to their GP's and trained pharmacists for blood pressure management. Of the 408 screened participants (40% of all Airdrie seniors), 36.5% had uncontrolled HBP. By program end, systolic BP was decreased by 16.8 mm (+/- 14.6. P <.05) and 56.2% of hypertensive participants had reached the 2006 Canadian Hypertension Guideline targets. Airdrie now holds annual blood pressure screenings organized and run by volunteers, demonstrating the sustainability of this approach to population screening and risk factor management in this setting.
In order to fully realize the benefits of cardiovascular risk reduction, U-CHAMP will be expanded to include a more global risk assessment and management protocol including assessments for dyslipidemias and diabetes in an urban setting.
The purpose of this project is:
- To expand the rural scope of A-CHAMP into a larger urban setting (Calgary).
- To include a more global risk assessment (for both coronary artery disease and stroke) and management including: cholesterol (total and HDL cholesterol) and diabetes (capillary HgA1c when appropriate).
- To effect fully sustainable practice change in the management of hypertension, diabetes and dyslipidemias by establishing collaborative partnerships between pharmacists, Calgary Health Region (CHR) physicians (Primary Care Networks: PCN's), the CHR Chronic Disease Management Program (CDM), and selected hypertensive patients.
Components of U-CHAMP are as follows:
- Screening Clinics:
- Visit 1: The pharmacist determines if the participant has diabetes then performs a BP assessment using a BpTRU device (VSM MedTech, Vancouver, BC). The participant is invited to sign the consent then six BP readings are taken 1 minute apart in the non-dominant arm, and the last five readings averaged. If the average reading is ≥140/90 mmHg (≥130/80 for diabetics), the participant is invited to return to a second BP clinic within the next 2 weeks.
- Visit 2: BP is taken as above. If the average BP from both visits is ≥140/90 mmHg (≥130/80 mmHg for those with diabetes), The client is invited to participate in the program.
- Intervention:
- Visit 2 continued: The pharmacist completes the assessment form which includes: age, personal or family history of cardiovascular disease, known diabetes, hypertension or dyslipidemia, lifestyle issues, medication list, medication allergies, adherence history, adverse events experienced and non-prescription medications used including herbs, vitamins, and supplements.
- Baseline random capillary Total Cholesterol, HDL (Cholestech -LDX ® (Manthomed) and HgA1c (DCA 2000) are obtained and with all the above information, the Framingham global cardiovascular risk score is calculated (for those without known vascular disease and those without diabetes). If the readings are above target (according to the most recent Canadian Guidelines for hypertension, dyslipidemias and diabetes), participants are encouraged to have their full lipid profile and HgA1c done by their family physician and to record the results in a wallet card provided to them. Counseling about global cardiovascular risk, medications (if applicable), lifestyle information, a hypertension education pamphlet (CHEP 2007 public education) and a wallet card are provided.
- Participants are referred to their primary care physician for further assessment/management. Assessment information with BP, lipid and HgA1c results and any recommendations (according to latest Canadian Guidelines) including the least expensive drug alternatives, are faxed to the participant's primary care physician.
- Follow-up:
- Participants are asked to return for follow-up several times during the 6 to 12 month program. Participants are encouraged to follow up with their GP's after each pharmacy visit (if appropriate).
- At each visit the participant's BP is re-checked. Medication counseling, lifestyle and other information is reinforced and the BP handbook is updated. If appropriate, any lipid, diabetes and global cardiovascular risk assessment data is recorded in the participants' wallet card and is reviewed with them. Counseling about the appropriate target levels is provided. Results of the assessment including recommendations and the pharmacist's comments from each visit are faxed to the participant's physician.
- Final Visit:
- Participants are encouraged to obtain a full lipid profile through their family physician (if appropriate) just prior to their final pharmacy visit (and bring the results to this final visit) so that their Framingham global cardiovascular risk can be recalculated.
The participant's BP, random capillary Total and HDL cholesterol and HgA1c (if appropriate) are measured. Their current medication list is confirmed and adherence information is reviewed and recorded. The final lipid and diabetes lab data (recorded in the BP handbook) is assessed and the global cardiovascular risk score is re-calculated to assess any changes. A copy of the final assessment is faxed to the participant's primary physician. Participants are encouraged to follow up with their GP.
- Conditions
- Cardiovascular Diseases, Hypertension, Hyperlipidemia, Hyperglycemia
- Being tested
- participant referral to primary care network physician
- Keywords
- Community pharmacies, Primary care networks, Global risk assessment, Blood pressure screening
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Hyperlipidemias, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participant referral to primary care network physicianOther
blood pressure, cholesterol and hemoglobin A1c screening and management
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | referral to primary care network for management of blood pressure, lipids and diabetes. Receives: Other: participant referral to primary care network physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure between baseline (average of visits one and two) and program end (final visit).
Measured: 12 months
Secondary outcomes (5)
Proportion of screened participants identified as being above blood pressure, cholesterol and blood glucose targets at visit two
Measured: 12 months
Proportion of participants that achieve published blood pressure (lipid and diabetes when appropriate) targets by program end
Measured: 12 months
Proportion of individuals that obtain both a baseline and end of program full lipid panel
Measured: 12 months
Change in Framingham Global Cardiovascular Risk score (in those participants that do not have known vascular disease or diabetes and have a recorded baseline and end-of-study full lipid panel).
Measured: 12 months
Proportion of individuals that have changes in drug therapy (new medication and/or dosage increase).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Investigators
- Charlotte Jones, PhD, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626041
- Sponsor's protocol ID
- 03 71550000144
- Acronym
- U-CHAMP
- Status last verified
- Jan 2010
- First submitted
- 14 Jan 2008
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
McLean DL, McAlister FA, Johnson JA, King KM, Jones CA, Tsuyuki RT. SCRIP-Hypertension program - Improving blood pressure management in patients with diabetes: The design of the SCRIP-HTN study. Canadian Pharmaceutical Journal 139: 1-4, 2006.
British Cardiac Society; British Hypertension Society; Diabetes UK; HEART UK; Primary Care Cardiovascular Society; Stroke Association. JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart. 2005 Dec;91 Suppl 5(Suppl 5):v1-52. doi: 10.1136/hrt.2005.079988. No abstract available.
PubMed 16365341
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- U-CHAMP: Urban Cardiovascular Health Assessment and Management Program
- ClinicalTrials.gov ID
- NCT00626041
- Acronym / sponsor ID
- U-CHAMP / 03 71550000144
- Conditions
- Cardiovascular Diseases, Hypertension, Hyperlipidemia, Hyperglycemia
- Keywords
- Community pharmacies, Primary care networks, Global risk assessment, Blood pressure screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 29 Feb 2008 (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.
High blood pressure, elevated blood glucose and high cholesterol are related to the increased risk of stroke and heart disease. Many studies have shown that this risk can be significantly reduced by lowering blood pressure, blood glucose and cholesterol levels.
Through a collaborative effort between Calgary Safeway pharmacists and Calgary Health Region family physician PCN's, U-CHAMP will deliver a program to assist in the identification and management of people with elevated blood pressure, blood glucose and cholesterol and through this effort, reduce the risk of heart disease and stroke in the urban Calgary population aged 18-85 years.
Detailed description
Hypertension (HBP) has long been correlated with risk of stroke and other adverse cardiovascular outcomes. Randomized controlled trials of blood pressure lowering have demonstrated at least 30% reductions in stroke incidence and improved mortality. Despite being such a readily modifiable risk, HBP remains under diagnosed and under treated. To address this gap, the A-CHAMP (Airdrie Community Hypertension Awareness and Management Program) was successfully piloted in Airdrie, a community of 20,000 north of Calgary, Alberta. Trained volunteers held BP screening sessions for seniors in local pharmacies and referred hypertensive participants to their GP's and trained pharmacists for blood pressure management. Of the 408 screened participants (40% of all Airdrie seniors), 36.5% had uncontrolled HBP. By program end, systolic BP was decreased by 16.8 mm (+/- 14.6. P <.05) and 56.2% of hypertensive participants had reached the 2006 Canadian Hypertension Guideline targets. Airdrie now holds annual blood pressure screenings organized and run by volunteers, demonstrating the sustainability of this approach to population screening and risk factor management in this setting.
In order to fully realize the benefits of cardiovascular risk reduction, U-CHAMP will be expanded to include a more global risk assessment and management protocol including assessments for dyslipidemias and diabetes in an urban setting.
The purpose of this project is:
- To expand the rural scope of A-CHAMP into a larger urban setting (Calgary).
- To include a more global risk assessment (for both coronary artery disease and stroke) and management including: cholesterol (total and HDL cholesterol) and diabetes (capillary HgA1c when appropriate).
- To effect fully sustainable practice change in the management of hypertension, diabetes and dyslipidemias by establishing collaborative partnerships between pharmacists, Calgary Health Region (CHR) physicians (Primary Care Networks: PCN's), the CHR Chronic Disease Management Program (CDM), and selected hypertensive patients.
Components of U-CHAMP are as follows:
- Screening Clinics:
- Visit 1: The pharmacist determines if the participant has diabetes then performs a BP assessment using a BpTRU device (VSM MedTech, Vancouver, BC). The participant is invited to sign the consent then six BP readings are taken 1 minute apart in the non-dominant arm, and the last five readings averaged. If the average reading is ≥140/90 mmHg (≥130/80 for diabetics), the participant is invited to return to a second BP clinic within the next 2 weeks.
- Visit 2: BP is taken as above. If the average BP from both visits is ≥140/90 mmHg (≥130/80 mmHg for those with diabetes), The client is invited to participate in the program.
- Intervention:
- Visit 2 continued: The pharmacist completes the assessment form which includes: age, personal or family history of cardiovascular disease, known diabetes, hypertension or dyslipidemia, lifestyle issues, medication list, medication allergies, adherence history, adverse events experienced and non-prescription medications used including herbs, vitamins, and supplements.
- Baseline random capillary Total Cholesterol, HDL (Cholestech -LDX ® (Manthomed) and HgA1c (DCA 2000) are obtained and with all the above information, the Framingham global cardiovascular risk score is calculated (for those without known vascular disease and those without diabetes). If the readings are above target (according to the most recent Canadian Guidelines for hypertension, dyslipidemias and diabetes), participants are encouraged to have their full lipid profile and HgA1c done by their family physician and to record the results in a wallet card provided to them. Counseling about global cardiovascular risk, medications (if applicable), lifestyle information, a hypertension education pamphlet (CHEP 2007 public education) and a wallet card are provided.
- Participants are referred to their primary care physician for further assessment/management. Assessment information with BP, lipid and HgA1c results and any recommendations (according to latest Canadian Guidelines) including the least expensive drug alternatives, are faxed to the participant's primary care physician.
- Follow-up:
- Participants are asked to return for follow-up several times during the 6 to 12 month program. Participants are encouraged to follow up with their GP's after each pharmacy visit (if appropriate).
- At each visit the participant's BP is re-checked. Medication counseling, lifestyle and other information is reinforced and the BP handbook is updated. If appropriate, any lipid, diabetes and global cardiovascular risk assessment data is recorded in the participants' wallet card and is reviewed with them. Counseling about the appropriate target levels is provided. Results of the assessment including recommendations and the pharmacist's comments from each visit are faxed to the participant's physician.
- Final Visit:
- Participants are encouraged to obtain a full lipid profile through their family physician (if appropriate) just prior to their final pharmacy visit (and bring the results to this final visit) so that their Framingham global cardiovascular risk can be recalculated.
The participant's BP, random capillary Total and HDL cholesterol and HgA1c (if appropriate) are measured. Their current medication list is confirmed and adherence information is reviewed and recorded. The final lipid and diabetes lab data (recorded in the BP handbook) is assessed and the global cardiovascular risk score is re-calculated to assess any changes. A copy of the final assessment is faxed to the participant's primary physician. Participants are encouraged to follow up with their GP.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: participant referral to primary care network physicianreferral to primary care network for management of blood pressure, lipids and diabetes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18-85 years
- Signed consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| participant referral to primary care network physicianblood pressure, cholesterol and hemoglobin A1c screening and management | Other | 1 |
Primary outcome
Change in systolic blood pressure between baseline (average of visits one and two) and program end (final visit).
Time frame: 12 months
5 secondary outcomes
Proportion of screened participants identified as being above blood pressure, cholesterol and blood glucose targets at visit two
Time frame: 12 months
Proportion of participants that achieve published blood pressure (lipid and diabetes when appropriate) targets by program end
Time frame: 12 months
Proportion of individuals that obtain both a baseline and end of program full lipid panel
Time frame: 12 months
Change in Framingham Global Cardiovascular Risk score (in those participants that do not have known vascular disease or diabetes and have a recorded baseline and end-of-study full lipid panel).
Time frame: 12 months
Proportion of individuals that have changes in drug therapy (new medication and/or dosage increase).
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- BackgroundMcLean DL, McAlister FA, Johnson JA, King KM, Jones CA, Tsuyuki RT. SCRIP-Hypertension program - Improving blood pressure management in patients with diabetes: The design of the SCRIP-HTN study. Canadian Pharmaceutical Journal 139: 1-4, 2006.
- Background: PubMed 16365341British Cardiac Society; British Hypertension Society; Diabetes UK; HEART UK; Primary Care Cardiovascular Society; Stroke Association. JBS 2: Joint British Societies' guidelines on prevention of cardiovascular disease in clinical practice. Heart. 2005 Dec;91 Suppl 5(Suppl 5):v1-52. doi: 10.1136/hrt.2005.079988. No abstract available.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Charlotte Jones, PhD, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing participant referral to primary care network physician in people with Cardiovascular Diseases and Hypertension, run by University of Calgary at 2 sites 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 2 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 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Donna M. Galvin, BScPharm (403 938-1589, dgalvin@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure between baseline (average of visits one and two) and program end (final visit). (time frame: 12 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 NCT00626041, which also lists 2 linked publications.
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 27 Jan 2010.