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ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program (ICA-CHAMP)

Primary Purpose

Cardiovascular Diseases, Hypertension, Hyperlipidemia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High risk assessment
Low to moderate risk
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cardiovascular Diseases focused on measuring community-based, culturally-sensitive, high risk assessment, education classes, cardiovascular risk profile, Indo-Asian population

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Indo-Cental Asian decent
  • Minimum 45 years of age
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy
  • Current cardiology specialist

Sites / Locations

  • Hindu Society of Calgary
  • Dashmesh Cultural Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

1

2

Arm Description

high risk

low to moderate risk

Outcomes

Primary Outcome Measures

Baseline and one year change in blood pressure and total cholesterol, HDL cholesterol and TC/HDL ratio (High and low to moderate risk program participants)

Secondary Outcome Measures

Cardiovascular risk profile and risk scores (Joint British Societies Cardiovascular Disease Risk Prediction Chart) of all participants at baseline and upon completion of the High Risk Assessment and Calgary Health Region Multicultural education programs.
Baseline profiles of attendees versus no-shows at both High Risk Assessment clinics and Calgary Health Region Multicultural education programs
"No-show" rates at High Risk Assessment clinics and Calgary Health Region Multicultural education program vs. historical rates.
Proportion of High Risk Assessment Clinic attendees identified as having occult Coronary Artery Disease and requiring angioplasty and/or Coronary Artery Bypass Graft.
Post Hoc variation of the Joint British Societies Cardiovascular Disease Risk Prediction Chart versus ETHRISK
Participant and community leader/volunteer satisfaction with the program
Participant opinion regarding usefulness of the culturally-sensitive educational information provided at the screening session.

Full Information

First Posted
January 14, 2008
Last Updated
February 20, 2008
Sponsor
University of Calgary
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00627159
Brief Title
ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program
Acronym
ICA-CHAMP
Official Title
ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Calgary
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Research has shown that the presence of heart disease and stroke is higher in the Indo-Asian population compared to other ethno-cultural groups. This may be due to multiple reasons such as a higher presence of diabetes, high blood pressure, high cholesterol, obesity, and lower levels of physical activity. This program will bring together the Calgary Indo-Central-Asian communities and the Calgary Healthcare community to help reduce the rate of heart disease and stroke through a supportive, culturally-sensitive program that is community-based through the following steps: Increase awareness of heart disease and stroke through education among the Calgary Indo-Central-Asian population. Identify early, the risk factors related to heart disease and stroke through screening programs. Provide appropriate follow-up care to the population at risk for heart disease and stroke.
Detailed Description
Coronary artery disease (CAD) is a leading cause of morbidity and mortality worldwide. Various studies have confirmed that individuals of SE Asian descent have a higher prevalence of cardiovascular disease compared with other ethnicities due to higher prevalence of metabolic syndrome, diabetes, insulin resistance, central obesity, dyslipidemias (lower high-density lipoprotein, increased lipoprotein[a], higher triglyceride levels), increased thrombotic tendency (increased plasminogen activator inhibitor-1 and decreased tissue plasminogen activator levels), and decreased levels of physical activity Hypertension, in particular has become one of the leading causes of mortality among Asians. Projected figures suggest that in Indo-Asians hypertension prevalence will increase from 16.3% to 19.5% between 1995 and 2025. Despite increased prevalence of hypertension among Indo-Asians, the majority of cases remain undetected and poorly managed. Disparities in health system utilization are associated with a high prevalence of hypertension leading to increased numbers of patients presenting with target organ damage such as stroke, heart failure and renal insufficiency. Epidemiological studies have demonstrated that high-risk ethnic groups have access barriers to mainstream programs and may benefit from targeted and culture specific interventions. Given that Indo-Asians represent an increasing proportion of the Canadian population and are at higher risk of cardiovascular diseases and experience health care access barriers, the initiation of an tailored risk factor screening and intervention program is timely. The collaborative effort between the target communities and the healthcare system provides an unique opportunity to develop and evaluate a sustainable screening, early detection and intervention program in hypertension and other CVD risk factors, tailored to meet the unique cultural needs of the target population. Only an all encompassing program of this scope will reduce the risk of cardiovascular diseases in this highly susceptible population. The project objectives are as follows: To increase Indo-Central Asian community awareness of cardiovascular risk factors To develop and implement a community based, culturally sensitive and self-sustaining cardiovascular risk factor screening and management program. To increase early detection of modifiable, undiagnosed, and uncontrolled cardiovascular risk factors Using a partnership-based, culturally appropriate and integrated approach, provide a sustainable and cost effective intervention program for optimal management of risk factors in the Indo-Central Asian population utilizing existing health region and community resources. To develop a continuum of care that addresses the needs of Indo-Central Asian Calgarians and that tailors the intensity of intervention to the perceived risk To validate the "Continuum of Care" process The project components are as follows: * Screening sessions: The project will utilize a previously developed Indo-Asian Diabetes Initiative methodology to recruit and train volunteers from the target community. Using standardized interview questions, the following information will be collected: age, gender, family history (first degree relative with premature cardiovascular disease), and other cardiovascular risk factors. Trained volunteers would administer the questions during one to one interviews in English or a common language used by the participant in the community. Blood pressures will be obtained using a validated Bp assessment tool (BpTRU). All those screened that have either high blood pressure (≥140/90 or ≥130/80 with diabetes) or at least one risk factor (positive family or personal history of cardiovascular disease, diabetes, smoker, known elevated cholesterol or on medications for HBP, lipids or diabetes) will then go on to have capillary measurements of random TC/HDL performed by the Cholestech desktop reflometer (Hayward CA). Based on health history and assessments obtained, the total CVD risk (coronary heart disease and stroke) will be predicted using the Joint British Societies Cardiovascular Disease Risk Prediction Chart. Those participants found to be high risk (>20 % 10 year CVD risk) will be referred, via the family physician, to a HRIC clinic. Those at moderate or low risk (≤20% 10 year CVD risk) will be referred to the CDM program. All participants that are screened will receive the adapted and culturally sensitive versions of the 2007 Canadian Public Recommendations education booklet (adapted by Blood Pressure Canada) that includes hypertension, dietary, alcohol and smoking cessation information. Intervention: All qualifying participants will be assessed by a volunteer pharmacist, nurse, physician, or other health care professional who will review the participants' current medications and provide education around adherence and adverse events. The completed assessments and the predicted risk scores will be reviewed with the participant. The predicted risk score will facilitate the participant's enrolment in the appropriate follow up program. Participants will be re-directed back to the family physician for BP monitoring and medication initiation or adjustment as required. Participants will be provided with a "Health Report" that will include their current medications, blood pressures, TC and HDL results, predicted CVD risk score and follow-up instructions. Interventions will be as follows: High CVD Risk Intervention: Individuals at high risk will be referred to a High Risk Intervention Clinic for full cardiovascular evaluation. This includes a history and physician exam by an Internal Medicine Specialist or alternate specialist with similar cardiovascular training and experience An ECG will be performed and likely either a stress test or nuclear cardiology study. Risk factors will be aggressively managed. Low and Moderate CVD Risk Intervention: Individuals at low or moderate risk will be referred to a convenient and culturally appropriate CDM community program (culturally sensitive education and physical activity programs). Follow-up Sessions: Consenting participants will be contacted by a project volunteer and be invited back for reassessment one year after initial evaluation. Reassessment will entail a work-up similar to that conducted during the initial screening session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Hypertension, Hyperlipidemia
Keywords
community-based, culturally-sensitive, high risk assessment, education classes, cardiovascular risk profile, Indo-Asian population

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
high risk
Arm Title
2
Arm Type
Other
Arm Description
low to moderate risk
Intervention Type
Other
Intervention Name(s)
High risk assessment
Intervention Description
For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All participants predicted to be at high risk are referred for assessment to a High Risk clinic in the community via the family doctor.
Intervention Type
Other
Intervention Name(s)
Low to moderate risk
Intervention Description
For all participants screened in the program, a cardiovascular risk profile is determined using information from the cardiovascular health history, blood pressure and cholesterol measurements, and The British Joint Societies Risk Prediction chart. All low to -moderate risk participants are directed to self-refer to the Calgary Health Region Multicultural education classes.
Primary Outcome Measure Information:
Title
Baseline and one year change in blood pressure and total cholesterol, HDL cholesterol and TC/HDL ratio (High and low to moderate risk program participants)
Time Frame
one year
Secondary Outcome Measure Information:
Title
Cardiovascular risk profile and risk scores (Joint British Societies Cardiovascular Disease Risk Prediction Chart) of all participants at baseline and upon completion of the High Risk Assessment and Calgary Health Region Multicultural education programs.
Time Frame
one year
Title
Baseline profiles of attendees versus no-shows at both High Risk Assessment clinics and Calgary Health Region Multicultural education programs
Time Frame
one year
Title
"No-show" rates at High Risk Assessment clinics and Calgary Health Region Multicultural education program vs. historical rates.
Time Frame
one year
Title
Proportion of High Risk Assessment Clinic attendees identified as having occult Coronary Artery Disease and requiring angioplasty and/or Coronary Artery Bypass Graft.
Time Frame
one year
Title
Post Hoc variation of the Joint British Societies Cardiovascular Disease Risk Prediction Chart versus ETHRISK
Time Frame
one year
Title
Participant and community leader/volunteer satisfaction with the program
Time Frame
one year
Title
Participant opinion regarding usefulness of the culturally-sensitive educational information provided at the screening session.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Indo-Cental Asian decent Minimum 45 years of age Signed informed consent Exclusion Criteria: Pregnancy Current cardiology specialist
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte - Jones, PhD, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hindu Society of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E 8M2
Country
Canada
Facility Name
Dashmesh Cultural Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3J 3G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
16493244
Citation
Bedi US, Singh S, Syed A, Aryafar H, Arora R. Coronary artery disease in South Asians: an emerging risk group. Cardiol Rev. 2006 Mar-Apr;14(2):74-80. doi: 10.1097/01.crd.0000182411.88146.72.
Results Reference
background
PubMed Identifier
15703505
Citation
Aarabi M, Jackson PR. Predicting coronary risk in UK South Asians: an adjustment method for Framingham-based tools. Eur J Cardiovasc Prev Rehabil. 2005 Feb;12(1):46-51.
Results Reference
background
PubMed Identifier
11071182
Citation
Anand SS, Yusuf S, Vuksan V, Devanesen S, Teo KK, Montague PA, Kelemen L, Yi C, Lonn E, Gerstein H, Hegele RA, McQueen M. Differences in risk factors, atherosclerosis, and cardiovascular disease between ethnic groups in Canada: the Study of Health Assessment and Risk in Ethnic groups (SHARE). Lancet. 2000 Jul 22;356(9226):279-84. doi: 10.1016/s0140-6736(00)02502-2.
Results Reference
background
Citation
Davachi S, Flynn M, Edwards A. A health region/community partnership for Type 2 diabetes risk factor screening in Indo-Asian communities. Canadian Journal of Diabetes 29(2):87-94, 2005.
Results Reference
background
PubMed Identifier
16762981
Citation
Brindle P, May M, Gill P, Cappuccio F, D'Agostino R Sr, Fischbacher C, Ebrahim S. Primary prevention of cardiovascular disease: a web-based risk score for seven British black and minority ethnic groups. Heart. 2006 Nov;92(11):1595-602. doi: 10.1136/hrt.2006.092346. Epub 2006 Jun 8.
Results Reference
background
PubMed Identifier
16365341
Citation
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.
Results Reference
background
Links:
URL
http://www.hypertension.ca
Description
Related Info
URL
http://www.heartandstroke.ca
Description
Related Info

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ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program

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