CVD Risk Factor Knowledge Across Age Groups

May 2, 2019 updated by: Pamela Bartlo, D'Youville College

Assessment of the Knowledge Level Regarding Cardiovascular Disease Risk Factors: Comparison Across Age Groups

This study was to examine the knowledge level regarding cardiovascular disease risk factors among participants of varying ages. Then to see if there was any type of previous education that led to greater knowledge levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study used a survey tool that assessed the participants' method(s) of prior education regarding cardiovascular disease (CVD) risk factors. Then the participant was asked eleven questions regarding CVD risk factors which tested their knowledge of those factors. Analysis was done to evaluate overall knowledge level of each group and compare the knowledge levels across age groups. Then analysis was done to see if any method(s) led to better knowledge level within and/or between age groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
381

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • were specific to age for each participant group and then also included full completion of the survey for all groups.

Exclusion Criteria:

  • age outside of specified population for each participant groups or incomplete survey for any participant regardless of group.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Children in grades 4 or 5
This group was comprised of participants that were in grades 4 or 5 in school.
Other: Survey tool to assess CVD risk factor knowledge
The survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors.
Active Comparator: Adolescents in grades 10 or 11
This group was comprised of participants that were in grades 10 or 11 in school.
Other: Survey tool to assess CVD risk factor knowledge
The survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors.
Active Comparator: College Age Participants
This group was comprised of participants that were sophomores or juniors in college/university that were non-health career majors.
Other: Survey tool to assess CVD risk factor knowledge
The survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors.
Active Comparator: Cardiac Rehab Adults
This group was comprised of participants that were adults over the age of 40 that had completed a phase II cardiac rehabilitation program.
Other: Survey tool to assess CVD risk factor knowledge
The survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors.
Active Comparator: General Adults
This group was comprised of participants that were adults over the age of 40 that had never attended an outpatient cardiac rehabilitation program before.
Other: Survey tool to assess CVD risk factor knowledge
The survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiovascular disease risk factor knowledge
Time Frame: 10-15 minutes
How well did the participant know the risk factors for cardiovascular disease. This was determined by using a survey tool that was shown to have internal validity using Chronbach alpha score. The survey had 11 questions regarding CVD risk factors and asked the participant if they felt the statement was completely true, somewhat true, neutral, somewhat untrue, or completely untrue. Survey scores were determined out of 55 total points.
10-15 minutes
Method(s) of education
Time Frame: 10-15 minutes
What methods of education regarding CVD risk factors did the participant previously have. The participant was asked various methods of previous education. These included school for younger participants, cardiac rehab for that group, TV, media, Internet, community groups, health care provider, family member experience, or family member discussion. The were tabulated individually and then comparisons were made within and between groups for methods of education used. Then these were correlated to survey scores too. These comparisons were made with chi-square with post-hoc tests, MANOVAs, and unpaired t-tests.
10-15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D'Youville College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVD Risk Factor Knowledge

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If other researchers would like to use data, non-identified results could be shared. Individual participant surveys would not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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