Cardiovascular Risk FactorNCT03936686
CVD Risk Factor Knowledge Across Age Groups
A study testing Survey tool to assess CVD risk factor knowledge in people with Cardiovascular Risk Factor, run by D'Youville College.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- Survey tool to assess CVD risk factor knowledge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- were specific to age for each participant group and then also included full completion of the survey for all groups.
Who cannot join
- age outside of specified population for each participant groups or incomplete survey for any participant regardless of group.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- Survey tool to assess CVD risk factor knowledge
- Keywords
- Education, Knowledge level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey tool to assess CVD risk factor knowledgeOther
The survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors.
| Study group | Role | What they receive |
|---|---|---|
| Children in grades 4 or 5 | Active comparator | This group was comprised of participants that were in grades 4 or 5 in school. Receives: Other: Survey tool to assess CVD risk factor knowledge |
| Adolescents in grades 10 or 11 | Active comparator | This group was comprised of participants that were in grades 10 or 11 in school. Receives: Other: Survey tool to assess CVD risk factor knowledge |
| College Age Participants | Active comparator | This group was comprised of participants that were sophomores or juniors in college/university that were non-health career majors. Receives: Other: Survey tool to assess CVD risk factor knowledge |
| Cardiac Rehab Adults | Active comparator | This group was comprised of participants that were adults over the age of 40 that had completed a phase II cardiac rehabilitation program. Receives: Other: Survey tool to assess CVD risk factor knowledge |
| General Adults | Active comparator | This group was comprised of participants that were adults over the age of 40 that had never attended an outpatient cardiac rehabilitation program before. Receives: Other: Survey tool to assess CVD risk factor knowledge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular disease risk factor knowledge
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.
Measured: 10-15 minutes
Method(s) of education
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.
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study startFeb 2013
- Primary completionDec 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There were five participant groups evaluated based on age groupings. These groups were compared within group and against each other.
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Youville College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Bartlo, D'Youville College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936686
- Sponsor's protocol ID
- CVD Risk Factor Knowledge
- Status last verified
- May 2019
- First submitted
- 30 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If other researchers would like to use data, non-identified results could be shared. Individual participant surveys would not be shared.
Publications
Bartlo P, Irion G, Voorhees J. Assessment of the Knowledge Level Regarding Cardiovascular Disease Risk Factors: Comparison Across Age Groups. J Community Health. 2020 Oct;45(5):1030-1037. doi: 10.1007/s10900-020-00824-w.
PubMed 32323174
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Knowledge Level Regarding Cardiovascular Disease Risk Factors: Comparison Across Age Groups
- ClinicalTrials.gov ID
- NCT03936686
- Acronym / sponsor ID
- CVD Risk Factor Knowledge
- Conditions
- Cardiovascular Risk Factor
- Keywords
- Education, Knowledge level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- D'Youville CollegeUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- There were five participant groups evaluated based on age groupings. These groups were compared within group and against each other.
| Arm | Type | Receives |
|---|---|---|
| Children in grades 4 or 5 | Active comparator | Other: Survey tool to assess CVD risk factor knowledgeThis group was comprised of participants that were in grades 4 or 5 in school. |
| Adolescents in grades 10 or 11 | Active comparator | Other: Survey tool to assess CVD risk factor knowledgeThis group was comprised of participants that were in grades 10 or 11 in school. |
| College Age Participants | Active comparator | Other: Survey tool to assess CVD risk factor knowledgeThis group was comprised of participants that were sophomores or juniors in college/university that were non-health career majors. |
| Cardiac Rehab Adults | Active comparator | Other: Survey tool to assess CVD risk factor knowledgeThis group was comprised of participants that were adults over the age of 40 that had completed a phase II cardiac rehabilitation program. |
| General Adults | Active comparator | Other: Survey tool to assess CVD risk factor knowledgeThis group was comprised of participants that were adults over the age of 40 that had never attended an outpatient cardiac rehabilitation program before. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- were specific to age for each participant group and then also included full completion of the survey for all groups.
Key exclusion criteria (1 listed)
- age outside of specified population for each participant groups or incomplete survey for any participant regardless of group.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey tool to assess CVD risk factor knowledgeThe survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors. | Other | Adolescents in grades 10 or 11, Cardiac Rehab Adults, Children in grades 4 or 5, College Age Participants, General Adults |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Derived from this study: PubMed 32323174Bartlo P, Irion G, Voorhees J. Assessment of the Knowledge Level Regarding Cardiovascular Disease Risk Factors: Comparison Across Age Groups. J Community Health. 2020 Oct;45(5):1030-1037. doi: 10.1007/s10900-020-00824-w.
- Individual participant dataSharing planned: Undecided. If other researchers would like to use data, non-identified results could be shared. Individual participant surveys would not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Survey tool to assess CVD risk factor knowledge in people with Cardiovascular Risk Factor, run by D'Youville College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular disease risk factor knowledge (time frame: 10-15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.