- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04530825
PREVENT Tool Study: Late Effects Clinic
Addressing Social Determinants of Health During Clinical Care Visits to Promote Equitable Behavior Change and PREVENT Cardiovascular Disease
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Providers
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No Intervention: Parents
-Semi-structured interviews
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Active Comparator: Patients - Wait-List Control
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-Will receive routine clinical care.
After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool
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Experimental: Patients - PREVENT tool
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-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese adolescent patients at the point of care.
PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey
Time Frame: At baseline and 3-months
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At baseline and 3-months
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Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey
Time Frame: At baseline and 3-months
|
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At baseline and 3-months
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Mean Change in Number of Food Intake Behaviors Met
Time Frame: At baseline and 3-months
|
Patient-reported food intake behaviors (fruit and vegetable intake, whole grains, sugar-sweetened beverages and snacking behaviors) are collected using a brief Health Behavior & Attitudes Survey.
Responses are dichotomized into a binary yes (1)/no (0) score indicating whether or not the patient is meeting the food intake recommendation for each food group.
The total number of food intake behaviors are scored on a 5 item scale (range 0-5), maximum improvement in number of behaviors=5.
Mean changes from baseline and 3-month follow-up were calculated as the follow-up measure minus the baseline measure, averaged across the intervention groups.
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At baseline and 3-months
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Provider's Satisfaction of PREVENT Tool: Survey
Time Frame: 3-months
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A survey (24-questions) containing validated subscales assessed provider's satisfaction with the PREVENT tool on subscales assessing acceptability, feasibility, and appropriateness of the tool, and satisfaction with specific components of the tool.
Items were scored on a 5-point Likert scale with a higher score indicating greater satisfaction.
Subscales were summed to generate the average across all questions (range 1-5) and was reported as overall satisfaction.
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3-months
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Fidelity of PREVENT Tool Implementation
Time Frame: 0-3 months
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Fidelity will be measured using direct observation of patient-provider interactions while using the PREVENT tool.
A direct observation checklist will be used by the observer to determine the number of interactions with the PREVENT tool that were implemented as intended.
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0-3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider's Motivation for Sustained Use of PREVENT Tool
Time Frame: 3-months
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A survey (8 questions) assessed provider's intent to change their behavior and continue using PREVENT.
Questions were adapted from Legare's CPD Reaction Questionnaire and asked using a 5-point Likert scale (range 1-5).
An average of all responses was calculated with a higher score indicating greater motivation for sustained use.
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3-months
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Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool
Time Frame: 3-months
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Qualitative in-depth interview with providers who used the PREVENT tool.
Qualitative content analysis methods were used to summarize key themes related to provider perceptions of the tool and ability to use the tool in routine clinical practice.
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3-months
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Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool
Time Frame: 3-months
|
Qualitative in-depth interview with providers who used the PREVENT tool.
Qualitative content analysis methods were used to summarize key themes related to provider perceptions of the tool and ability to use the tool in routine clinical practice.
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3-months
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Patient's Perceptions of Usability/Acceptability of PREVENT Tool
Time Frame: 3-months
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Semi-structured interviews with adolescent study participants (n=10).
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3-months
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Parent's Perceptions of Usability/Acceptability of PREVENT Tool
Time Frame: 3-months
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Semi-structured interviews with parents/guardians (n=10) of study participants.
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3-months
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Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)
Time Frame: At baseline and 3-months
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Collected from patient's medical record.
BMI z-score is a standardized calculation accounting age and sex using the Centers for Disease Control and Prevention Growth Charts.
A z-score represents the standard deviation from the population mean.
A z-score of zero represents the population mean.
Mean change in BMI z-score was calculated by subtracting the baseline mean from the follow-up mean for each intervention group.
A decrease in z-score is a favorable outcome.
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At baseline and 3-months
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Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure
Time Frame: At baseline and 3-months
|
Collected from patient's medical record.
Blood pressure is measured in mmHg.
The mean change was calculated by subtracting the baseline mean from the follow-up mean for each intervention group.
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At baseline and 3-months
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Impact of PREVENT Tool on Patient's Cholesterol
Time Frame: At baseline and 3-months
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Collected from patient's medical record
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At baseline and 3-months
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Impact of PREVENT Tool on Patient's Fasting Blood Glucose
Time Frame: At baseline and 3-months
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Collected from patient's medical record
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At baseline and 3-months
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Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change
Time Frame: At baseline and 3-months
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A survey (6-question) administered to patients will assess attitudes toward and readiness for behavior change.
Questions are asked using a 5-point Likert scale (range: 0-5) with a higher score indicating more positive attitudes.
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At baseline and 3-months
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Clinic-level Capacity for Sustainability as Measured by Provider Survey
Time Frame: 3-months
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The Clinical Sustainability Assessment Tool (CSAT) will assess clinic-level readiness and capacity for sustainability of the PREVENT tool.
The CSAT tool will examine organization, financial, regulatory and political factors that may influence sustainability.
10 items scored on a 7-point scale, with higher scores indicating greater capacity for sustainment.
The average of the 10 items is reported (range 1-7).
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3-months
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202007026
- K12HL137942 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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