Clinical trial NCT04530825: PREVENT Tool Study: Late Effects Clinic
Official title: Addressing Social Determinants of Health During Clinical Care Visits to Promote Equitable Behavior Change and PREVENT Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Childhood Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-08-28
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the feasibility of a novel, Health Information Technology behavior change tool in a single clinic setting. The PREVENT tool is the first electronic health record (EHR)-compatible tool that both tailors evidence-based behavior change strategies and incorporates community-level data specific to each patient into routine care. The central hypothesis is that PREVENT will improve patient's attitudes towards behavior change recommendations, increase adherence to recommended behavior change and improve cardiovascular health. Fifty adolescents will be randomized to intervention or wait-list, routine care control to assess the preliminary effectiveness of PREVENT. Qualitative and quantitative methods will be used among patients, parents and providers to examine barriers to current and future implementation of the PREVENT tool to inform adoption and maintenance.


Eligibility criteria: Inclusion Criteria:

Patient Eligibility Criteria:

* Adolescents 12 to 19 years
* Prior diagnosis of pediatric cancer (diagnosed \<21 years of age)
* Not receiving active therapy for their cancer
* Receiving care from the Pediatric Hematology/Oncology staff and physicians at St. Louis Children's Hospital or the St. Louis Children's Specialty Care Center (CSCC)
* At risk for poor cardiovascular health (CVH) (BMI greater than or equal to 85th percentile)

Provider Eligibility Criteria -All providers and staff (physicians, nurses, clinic staff, clinical research associates) in the Pediatric Hematology/Oncology program at St. Louis Children's Hospital and the CSCC

Parent Eligibility Criteria

-A parent or legal guardian of a study participant. The parent or legal guardian must have been present at the clinic visit in which the PREVENT tool was administered to the study participant.

Primary outcomes:
measure: Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey
timeFrame: At baseline and 3-months
measure: Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey
timeFrame: At baseline and 3-months
measure: Mean Change in Number of Food Intake Behaviors Met
timeFrame: At baseline and 3-months
measure: Provider's Satisfaction of PREVENT Tool: Survey
timeFrame: 3-months
measure: Fidelity of PREVENT Tool Implementation
timeFrame: 0-3 months
Secondary outcomes:
measure: Provider's Motivation for Sustained Use of PREVENT Tool
timeFrame: 3-months
measure: Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool
timeFrame: 3-months
measure: Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool
timeFrame: 3-months
measure: Patient's Perceptions of Usability/Acceptability of PREVENT Tool
timeFrame: 3-months
measure: Parent's Perceptions of Usability/Acceptability of PREVENT Tool
timeFrame: 3-months
measure: Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)
timeFrame: At baseline and 3-months
measure: Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure
timeFrame: At baseline and 3-months
measure: Impact of PREVENT Tool on Patient's Cholesterol
timeFrame: At baseline and 3-months
measure: Impact of PREVENT Tool on Patient's Fasting Blood Glucose
timeFrame: At baseline and 3-months
measure: Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change
timeFrame: At baseline and 3-months
measure: Clinic-level Capacity for Sustainability as Measured by Provider Survey
timeFrame: 3-months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Maura Kepper, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: