Clinical trial NCT05384834: Incorporating CV Risk Assessment in AYA Visits
Official title: Incorporating Cardiovascular Risk Assessment Into Adolescent and Young Adult Visits to Improve Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-05-20
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: #HerHEART Risk Score in AYA From Baseline
timeFrame: Baseline, 3 months post-enrollment
measure: Overall Composite of Diet Score
timeFrame: Baseline, 3 months months post-enrollment
measure: Fruit and Vegetable Intake
timeFrame: Baseline, 3 months post- post-enrollment
measure: Red and Processed Meats Intake
timeFrame: Baseline, 3 months post-enrollment
measure: Sugar and Sweetened Beverages
timeFrame: Baseline, 3 months post-enrollment
measure: Nut Consumption
timeFrame: Baseline, 3 months post-intervention
measure: Alcohol Consumption
timeFrame: Baseline, 3 months post-enrollment
measure: Nicotine Use
timeFrame: Baseline, 3 months post-enrollment
measure: Cereal Fiber
timeFrame: Baseline, 3 months post-enrollment
measure: Physical Activity
timeFrame: Baseline, 3 months post-enrollment
Secondary outcomes:
measure: BMI From Baseline
timeFrame: Baseline, 3 month post-enrollment
measure: Systolic Blood Pressure (BP) From Baseline
timeFrame: Baseline, 3 month post-enrollment
measure: Diastolic Blood Pressure (BP) From Baseline
timeFrame: Baseline, 3 month post-enrollment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Hughes Spalding Research Room
state: Georgia
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
Study officials:
affiliation: Emory University
name: Holly Gooding, MD
role: PRINCIPAL_INVESTIGATOR
References: