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Study Design

Background

  • Between 1998 when CARDIAC was created and 2003 when the grant was funded, several different CARDIAC Screening procedures had been used to try and improve participation. These included:
    • the "fingerstick" approach to screening, where staff obtained a few drops of blood from the child’s finger and tested it immediately for cholesterol,
    • the "fasting lipid test" approach, where phlebotomists drew a tube of blood from the child’s arm and sent the blood to the lab for testing, and
    • the "voucher" approach, where children received coupons for testing at a lab rather than have any blood testing done at school.

Randomization

  • The research design for the grant was planned using the fingerstick approach. When the grant was awarded, all counties that used the fingerstick were considered for inclusion in the project. Counties were rank ordered from smallest to largest based on the number of eligible 5th graders, and were included until we had approximately 3500 eligible students (12 counties). These counties were randomly assigned to the Standard Condition or Tailored Condition.

Recruitment for Screening

  • The CARDIAC recruitment process for screening 5th graders was as follows:
    • School nurses or CARDIAC field staff spoke to students in their classrooms to discuss CARDIAC. The program was introduced using a Teaching Poster and Talking Points.
    • Consent forms were distributed for students to take home.
    • Students were instructed to return the forms to the school indicating whether they would or would not participate.
    • Parents were required to provide written informed consent and the student was required to provide written informed assent to participate.

Study Design - Study 1: Interviews

Study 1- (Spring-Summer 2004)

Study Design 1Focus GroupWe conducted individual and focus group interviews with 5th grade children, parents, and community leaders to identify health beliefs and perceptions that hinder or foster participation in the CARDIAC screening program, and to identify acceptable methods to address those barriers. Interviews took place in the Tailored counties. Child interviews (with 92 children) took place within the school setting and lasted 45-60 minutes. Parent and community leader interviews (with 50 adults) occurred in public settings such as libraries and county courthouses and lasted between 60-90 minutes.

Study Design - Study 2: Health Beliefs Questionnaires

Study 2- (Fall 2004)

Study design 2From the focus group and individual interviews with 5th grade children, parents, and community leaders, we created 3 Health Beliefs Questionnaires with questions about health, health screenings, heart disease, weight, exercise, and diet. The Theory of Planned Behavior provided the conceptual framework for understanding barriers and guided the development of the questionnaire. Three Tailored and 3 Standard counties participated in this study to control for any effects that questionnaire completion may have on CARDIAC participation. In each of these six counties, the names of all 5th graders were alphabetized, and Health Belief Questionnaires were sent by mail to every 6th student and their parent. Community Leaders (such as mayors, city council members, school superintendents, hospital board presidents) were also sent questionnaires in the mail. The 3 HBQ are: 1.HBQ for kids: to gather information about 5th graders’ beliefs about their health and health habits 2.HBQ for adults: to gather information about adults’ views about their own health and habits 3.HBQ for parents: to gather information about adults’ views about their child’s health

Study Design - Study 3: Screening

Study 3- (Fall 2004 through Spring 2006)

Children participantsFrom both the Health Beliefs Questionnaires and the interview data, the research team developed a belief-based intervention to try and improve participation for 5th grade students in the CARDIAC Screening. These Tailored Interventions were compared with the Standard CARDIAC procedures for Screening. The CARDIAC Screenings took place at the child’s school during regular class-time. Parents were allowed to be present, but their attendance was not mandatory for the child to participate.

At the start of the NHLBI Project, counties were encouraged to do what was necessary (county specific) to encourage participation in the CARDIAC Project. Consequently, the recruitment process of participants was different across all counties in the state. Different methods were used for introducing CARDIAC to students, awarding children for participating in the screening, and reminding children about the screening. In order to obtain a baseline measurement of the participation in the screenings, the NHLBI staff developed a Standard Approach to recruiting children for the screening. During the 2003-4 school years, the participating 12 counties were asked to follow a standardized method for introducing CARDIAC to the students. The standardized plan consisted of fixed introductions to the project, incentives for returning consents and participating in screening, and reminders to children about the screening. Further explanation of each of these areas is listed below.

Study Design - Study 4: Diagnosis

Study 4- (Fall 2005-Spring 2006)

Study Design 4Children who had high cholesterol values on the fingerstick during CARDIAC Screening, or who had Acanthosis Nigricans (AN)* were recommended to receive a fasting lipid profile (FLP) bloodtest, and were given a coupon for a free test for the student and his/her parents. To participate in the FLPs (CARDIAC Diagnosis), parents brought their child to a nearby clinic on one of several scheduled dates. Parents of children who participated in the FLP were interviewed via the telephone to determine reasons for completion/non-completion of the FLP, satisfaction with the CARDIAC program, and any reported changes in diet, activity level, or health care that had occurred. Click here to see Follow-Up Phone Calls to Parents after Screening.

*Acanthosis Nigricans (AN) is a skin problem often found on the neck, axilla, groin, and other flexural areas. Literally, AN means thick, coarse, and dark. Scientists have found that AN is a marker for high levels of insulin. (Diabetes Public Health Resource)