Trial Outcomes & Findings for Incorporating CV Risk Assessment in AYA Visits (NCT NCT05384834)

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline, 3 months post-enrollment

Results posted on

2023-10-13

Participant Flow

Participants were enrolled from Children's Healthcare of Atlanta - Hughes Spalding Research Room in Atlanta, Georgia, USA. Participant enrollment began July 01, 2022, and all follow-up assessments were completed by April 03, 2023.

The healthcare providers (HCPs) were instructed to complete a short anonymous survey without demographic information. Demographic information was not required to answer the survey. HCPs were not enrolled. They were not actually part of the clinical trial, per the NIH definition of a clinical trial.

Participant milestones

Participant milestones
Measure	AYA Participants 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. #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.
Overall Study STARTED	60
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	48

Reasons for withdrawal

Reasons for withdrawal
Measure	AYA Participants 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. #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.
Overall Study Lost to Follow-up	43
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Incorporating CV Risk Assessment in AYA Visits

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AYA Participants n=60 Participants 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. #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.
Age, Categorical <=18 years	44 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	17 years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months post-enrollment

Population: Includes all participants who completed the baseline questionnaires, and the three months follow-up includes only those who completed the study activities at the specific time point. Even though twelve (12) participants completed all activities, data was lost on 2 individuals. HCPs, n=5 from the same two clinical practices in Atlanta, Georgia were recruited by the research coordinator only to understand their perspectives about incorporating the HerHeart tool into clinical practice.

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%.