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

NCT00627159

Last updated date
Study Location
Hindu Society of Calgary
Calgary, Alberta, T2E 8M2, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cardiovascular Diseases, Hypertension, Hyperlipidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Indo-Cental Asian decent

- Minimum 45 years of age

- Signed informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnancy


- Current cardiology specialist

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Cardiovascular Diseases, Hypertension, HyperlipidemiaICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program
NCT00627159
  1. Calgary, Alberta
  2. Calgary, Alberta
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program
Official Title  ICMJE ICA-CHAMP: Indo-Central Asian Cardiovascular Health Assessment and Management Program
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:

  1. Increase awareness of heart disease and stroke through education among the Calgary Indo-Central-Asian population.
  2. Identify early, the risk factors related to heart disease and stroke through screening programs.
  3. 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Cardiovascular Diseases
  • Hypertension
  • Hyperlipidemia
Intervention  ICMJE
  • Other: High risk assessment
    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.
  • Other: Low to moderate risk
    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.
Study Arms  ICMJE
  • 1
    high risk
    Intervention: Other: High risk assessment
  • 2
    low to moderate risk
    Intervention: Other: Low to moderate risk
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 20, 2008)
375
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2008
Estimated Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Current cardiology specialist
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00627159
Other Study ID Numbers  ICMJE NRA3840015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Charlotte Jones, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Charlotte - Jones, PhD, MDUniversity of Calgary
PRS Account University of Calgary
Verification Date February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP