- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03936686
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
381
Phase
- 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
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 |
Intervention / Treatment |
---|---|
Active Comparator: Children in grades 4 or 5
This group was comprised of participants that were in grades 4 or 5 in school.
|
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.
|
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.
|
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.
|
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.
|
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
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
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.
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)
February 1, 2013
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
August 1, 2018
Study Registration Dates
First Submitted
April 30, 2019
First Submitted That Met QC Criteria
May 1, 2019
First Posted (Actual)
May 3, 2019
Study Record Updates
Last Update Posted (Actual)
May 6, 2019
Last Update Submitted That Met QC Criteria
May 2, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID 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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