Cardiovascular DiseasesNCT05384834
Incorporating CV Risk Assessment in AYA Visits
A study testing #HerHeart tool in people with Cardiovascular Diseases, run by Emory University at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the web tool #HerHeart's usability and feasibility in adolescent and young adult women (AYA) and the opinion of their healthcare providers (HCP). Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- #HerHeart tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2022to 3 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient at CHOA Hughes Spalding Adolescent Medicine Practice or the Grady Health System Teen Program
- Age 13-21 years
- Self-identifying as non-Hispanic Black or White race (inclusive of Hispanic ethnicity)
- Self-identifying as female
- Visit type is annual wellness/health check, behavioral/mental health, or reproductive/gynecological health
- Consistent access to a mobile device with internet capability
- Clinical team member (physician or nurse practitioner, nurse, social worker, psychologist, health educator, medical assistant, dietitian) at the CHOA Hughes Spalding Adolescent Medicine Practice or the Grady Health System Teen Program
- Practicing at one of the study sites at least twice per month on average over the past year
Who cannot join
- Cognitive impairment limiting ability to complete study procedure
- Spoken and written language other than English
- Diagnosis of hypertension, diabetes, or hyperlipidemia requiring medications, or atherosclerotic cardiovascular disease
- Past or current diagnosis of a DSM-V eating disorder
- Diagnosis of schizophrenia, bipolar disorder, or psychiatric hospitalization in the past 12 months
- Pregnant at the time of the study.
- Member of the research study team
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta - Hughes Spalding Research Room
Atlanta, Georgia, 30303
Grady Health System
Atlanta, Georgia, 30303
About this study
Official title: Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health
The purpose of this study is to evaluate the web tool #HerHeart's usability and feasibility in adolescent and young adult women (AYA) and the opinion of their healthcare providers (HCP).
Read the detailed description
The objective of the proposed research is to increase young women's perceived susceptibility to CVD and provide a cue to action to adopt heart-healthy behaviors. The aim of the proposed study is to evaluate the usability and initial feasibility of #HerHeart. The investigators will recruit 30 AYA participants and will ask 10 HCPs to evaluate the usability and feasibility of the web tool.
The study population will include female patients ages 13-21 years from the CHOA Adolescent Medicine Practice and Grady Teen Health Program. Part of our study population will be considered vulnerable (children under the age of 18 years). Subjects will be recruited via phone in advance of a clinical visit, from the waiting rooms of each clinic at the time of their appointment (in-person) or via Zoom at a time scheduled after their telehealth appointment (virtual). Written informed consent will be obtained for subjects 18 years and older. For subjects younger than 18 years, written parental permission (unless doing so would violate the adolescents' right to privacy, in which the Waiver of Parental Permission will be invoked) and written informed assent will be obtained. All consent procedures will take place in a private research room of each clinic (for in-person visits) or via Zoom videoconferencing (for virtual visits). Participants who agree to participate will attend a study visit at the Emory Children's Center Research Unit.
Data for this study will be collected from participants via surveys/questionnaires, and semi-structured interviews that will be audio-recorded. Data collected will include demographic information, cardiovascular disease risk information, health metrics (BMI, blood pressure), cognitive data (perceived stress, quality of life), and participant feedback on a mobile app intervention. All subjects will receive a study identification number. Only the PI will have the codes linking the study identification numbers to subjects and these codes will be stored in a locked cabinet. All data will be collected in a private research room in the clinics (in-person visits) or in a password-protected Zoom videoconference (virtual). All study staff will complete biomedical or socio-behavioral training through the Collaborative IRB Training Initiative Program (CITI). Data will be stored on the Emory servers in password-protected files.
- Conditions
- Cardiovascular Diseases
- Being tested
- #HerHeart tool
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
#HerHeart toolBehavioural
An integrated application consisting of a lifestyle-based CVD risk assessment and companion behavioral intervention. It will be administered at baseline and 3 months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| AYA participants | Experimental | AYA participants will complete a brief initial survey consisting of demographic information and the Visual Analog Scale (VAS) and the #HerHeart tool in clinic. AYA participants will the rate the usability of the #HerHeart tool using the Website Analysis and Measurement Inventory (WAMMI), the likelihood they would recommend the app to their friends, and the likelihood of behavior change. AYA participants will then be offered the opportunity to continue into the 3-month intervention phase. Receives: Behavioral: #HerHeart tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
#HerHEART Risk Score in AYA From Baseline
Risk is assessed based on answers surrounding the most critical diet and lifestyle factors that can influence a person's CVD risk. The factors include exercise, intake of fruits, vegetables, grains, nuts, sugary beverages and red/processed meats, and exercise. The Healthy Heart Score algorithm will be used to calculate the relative percent risk score of participants. Participants with a higher percent risk score have a higher risk for CVD based on their current reported habits. Those at low risk will have a risk score <10%, moderate risk a risk score between 10 and 15%, and high risk a score above 15%.
Measured: Baseline, 3 months post-enrollment
Overall Composite of Diet Score
Diet score = (0.03626 × grams/d of cereal fiber + 0.18283 [if fruits + vegetables ≥3 servings/d] + 0.14522 [if nuts 0.1-1 servings/d + 0.2444 [if nuts >1 servings/d]- 0.14631 × servings/d of sugar-sweetened beverages - 0.15624 × servings/d of red and processed meats)*10 A higher score implies better diet quality. An increase in diet score correlates with a better outcome.
Measured: Baseline, 3 months months post-enrollment
Fruit and Vegetable Intake
Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome.
Measured: Baseline, 3 months post- post-enrollment
Red and Processed Meats Intake
Intake will be measured with number of servings per day. A decrease in consumption is associated with a better outcome.
Measured: Baseline, 3 months post-enrollment
Sugar and Sweetened Beverages
Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome.
Measured: Baseline, 3 months post-enrollment
Nut Consumption
Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome.
Measured: Baseline, 3 months post-intervention
Alcohol Consumption
Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.
Measured: Baseline, 3 months post-enrollment
Nicotine Use
Self-reported smoker status will be obtained and classified as: Never smoke, used to smoke, current smoker. Investigators will look at changes in smoking status where a decrease in use is associated with a better outcome.
Measured: Baseline, 3 months post-enrollment
Cereal Fiber
Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome.
Measured: Baseline, 3 months post-enrollment
Physical Activity
Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome.
Measured: Baseline, 3 months post-enrollment
Secondary outcomes (3)
BMI From Baseline
AYA participant's BMI will be measured during the clinic appointment when participant is recruited. AYA participants will then be asked to return for a study visit 3 months post intervention where their BMI will be measured again. Change in BMI will be measured with a decrease in BMI being associated with a positive outcome and an increase in BMI being associated with a negative outcome.
Measured: Baseline, 3 month post-enrollment
Systolic Blood Pressure (BP) From Baseline
AYA participants' systolic BP (SBP) will be measured during the clinic appointment when the participant is recruited. AYA participants will then be asked to return for a study visit 3 months post-intervention where their BP will be measured again. Change in SBP will be measured with a decrease in SBP being associated with a positive outcome and an increase in SBP being associated with a negative outcome.
Measured: Baseline, 3 month post-enrollment
Diastolic Blood Pressure (BP) From Baseline
AYA participants' diastolic BP (DBP) will be measured during the clinic appointment when the participant is recruited. AYA participants will then be asked to return for a study visit 3 months post-intervention where their BP will be measured again. Change in DBP will be measured with a decrease in diastolic BP being associated with a positive outcome and an increase in BP being associated with a negative outcome.
Measured: Baseline, 3 month post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Jul 2022
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Holly Gooding, Emory University
- Investigators
- Holly Gooding, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384834
- Sponsor's protocol ID
- STUDY00001418
- Other IDs
- 1R03HL155253-01
- Status last verified
- Oct 2023
- First submitted
- 13 May 2022
- Last updated
- 13 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health
- ClinicalTrials.gov ID
- NCT05384834
- Acronym / sponsor ID
- STUDY00001418
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 20 May 2022 (actual)
- Results
- Posted 10 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the web tool #HerHeart's usability and feasibility in adolescent and young adult women (AYA) and the opinion of their healthcare providers (HCP).
Detailed description
The objective of the proposed research is to increase young women's perceived susceptibility to CVD and provide a cue to action to adopt heart-healthy behaviors. The aim of the proposed study is to evaluate the usability and initial feasibility of #HerHeart. The investigators will recruit 30 AYA participants and will ask 10 HCPs to evaluate the usability and feasibility of the web tool.
The study population will include female patients ages 13-21 years from the CHOA Adolescent Medicine Practice and Grady Teen Health Program. Part of our study population will be considered vulnerable (children under the age of 18 years). Subjects will be recruited via phone in advance of a clinical visit, from the waiting rooms of each clinic at the time of their appointment (in-person) or via Zoom at a time scheduled after their telehealth appointment (virtual). Written informed consent will be obtained for subjects 18 years and older. For subjects younger than 18 years, written parental permission (unless doing so would violate the adolescents' right to privacy, in which the Waiver of Parental Permission will be invoked) and written informed assent will be obtained. All consent procedures will take place in a private research room of each clinic (for in-person visits) or via Zoom videoconferencing (for virtual visits). Participants who agree to participate will attend a study visit at the Emory Children's Center Research Unit.
Data for this study will be collected from participants via surveys/questionnaires, and semi-structured interviews that will be audio-recorded. Data collected will include demographic information, cardiovascular disease risk information, health metrics (BMI, blood pressure), cognitive data (perceived stress, quality of life), and participant feedback on a mobile app intervention. All subjects will receive a study identification number. Only the PI will have the codes linking the study identification numbers to subjects and these codes will be stored in a locked cabinet. All data will be collected in a private research room in the clinics (in-person visits) or in a password-protected Zoom videoconference (virtual). All study staff will complete biomedical or socio-behavioral training through the Collaborative IRB Training Initiative Program (CITI). Data will be stored on the Emory servers in password-protected files.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AYA participants | Experimental | Behavioral: #HerHeart toolAYA participants will complete a brief initial survey consisting of demographic information and the Visual Analog Scale (VAS) and the #HerHeart tool in clinic. AYA participants will the rate the usability of the #HerHeart tool using the Website Analysis and Measurement Inventory (WAMMI), the likelihood they would recommend the app to their friends, and the likelihood of behavior change. AYA participants will then be offered the opportunity to continue into the 3-month intervention phase. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patient at CHOA Hughes Spalding Adolescent Medicine Practice or the Grady Health System Teen Program
- Age 13-21 years
- Self-identifying as non-Hispanic Black or White race (inclusive of Hispanic ethnicity)
- Self-identifying as female
- Visit type is annual wellness/health check, behavioral/mental health, or reproductive/gynecological health
Key exclusion criteria (7 listed)
- Cognitive impairment limiting ability to complete study procedure
- Spoken and written language other than English
- Diagnosis of hypertension, diabetes, or hyperlipidemia requiring medications, or atherosclerotic cardiovascular disease
- Past or current diagnosis of a DSM-V eating disorder
- Diagnosis of schizophrenia, bipolar disorder, or psychiatric hospitalization in the past 12 months
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 |
|---|---|---|
| #HerHeart toolAn integrated application consisting of a lifestyle-based CVD risk assessment and companion behavioral intervention. It will be administered at baseline and 3 months follow-up. | Behavioural | AYA participants |
Primary outcome
#HerHEART Risk Score in AYA From Baseline
Time frame: Baseline, 3 months post-enrollment
Risk is assessed based on answers surrounding the most critical diet and lifestyle factors that can influence a person's CVD risk. The factors include exercise, intake of fruits, vegetables, grains, nuts, sugary beverages and red/processed meats, and exercise. The Healthy Heart Score algorithm will be used to calculate the relative percent risk score of participants. Participants with a higher percent risk score have a higher risk for CVD based on their current reported habits. Those at low risk will have a risk score <10%, moderate risk a risk score between 10 and 15%, and high risk a score above 15%.
Overall Composite of Diet Score
Time frame: Baseline, 3 months months post-enrollment
Diet score = (0.03626 × grams/d of cereal fiber + 0.18283 [if fruits + vegetables ≥3 servings/d] + 0.14522 [if nuts 0.1-1 servings/d + 0.2444 [if nuts >1 servings/d]- 0.14631 × servings/d of sugar-sweetened beverages - 0.15624 × servings/d of red and processed meats)*10 A higher score implies better diet quality. An increase in diet score correlates with a better outcome.
Fruit and Vegetable Intake
Time frame: Baseline, 3 months post- post-enrollment
Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome.
Red and Processed Meats Intake
Time frame: Baseline, 3 months post-enrollment
Intake will be measured with number of servings per day. A decrease in consumption is associated with a better outcome.
Sugar and Sweetened Beverages
Time frame: Baseline, 3 months post-enrollment
Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome.
Nut Consumption
Time frame: Baseline, 3 months post-intervention
Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome.
Alcohol Consumption
Time frame: Baseline, 3 months post-enrollment
Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.
Nicotine Use
Time frame: Baseline, 3 months post-enrollment
Self-reported smoker status will be obtained and classified as: Never smoke, used to smoke, current smoker. Investigators will look at changes in smoking status where a decrease in use is associated with a better outcome.
Cereal Fiber
Time frame: Baseline, 3 months post-enrollment
Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome.
Physical Activity
Time frame: Baseline, 3 months post-enrollment
Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome.
3 secondary outcomes
BMI From Baseline
Time frame: Baseline, 3 month post-enrollment
Systolic Blood Pressure (BP) From Baseline
Time frame: Baseline, 3 month post-enrollment
Diastolic Blood Pressure (BP) From Baseline
Time frame: Baseline, 3 month post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Holly Gooding, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing #HerHeart tool in people with Cardiovascular Diseases, run by Emory University at 2 sites in United States.
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 8 inclusion and 7 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
#HerHEART Risk Score in AYA From Baseline (time frame: Baseline, 3 months post-enrollment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2023.