Incorporating CV Risk Assessment in AYA Visits

Cardiovascular Diseases Clinical Trial

Official title:

Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05384834
• Other study ID #: STUDY00001418
• Secondary ID: 1R03HL155253-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: April 3, 2023

Study information

• Verified date: October 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria (AYAs):

• 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

Exclusion Criteria (AYAs):

• 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.

Inclusion Criteria (HCPs) to complete feasibility surveys:

• 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

Exclusion Criteria (HCPs)

• Member of the research study team

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• #HerHeart tool
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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Hughes Spalding Research Room	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	#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%.	Baseline, 3 months post-enrollment
Primary	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.	Baseline, 3 months months post-enrollment
Primary	Fruit and Vegetable Intake	Intake will be measured with number of servings per day. Increase in servings/day correlates with a better outcome.	Baseline, 3 months post- post-enrollment
Primary	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.	Baseline, 3 months post-enrollment
Primary	Sugar and Sweetened Beverages	Intake will be measured with number of servings per week. A decrease in consumption is associated with a better outcome.	Baseline, 3 months post-enrollment
Primary	Nut Consumption	Intake will be measured with number of servings per week. An increase in intake is associated with a better outcome.	Baseline, 3 months post-intervention
Primary	Alcohol Consumption	Number of participants who consume alcohol will be collected. No alcohol consumption is associated with a better outcome.	Baseline, 3 months post-enrollment
Primary	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.	Baseline, 3 months post-enrollment
Primary	Cereal Fiber	Consumption of cereal will be measured in g/day. An increase in cereal fiber is associated with a better outcome.	Baseline, 3 months post-enrollment
Primary	Physical Activity	Physical activity will be measured in number of hours per week. Increase in physical activity associated with a better outcome.	Baseline, 3 months post-enrollment
Secondary	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.	Baseline, 3 month post-enrollment
Secondary	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.	Baseline, 3 month post-enrollment
Secondary	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.	Baseline, 3 month post-enrollment