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Cardiovascular DiseasesNCT06121193

Using Interventional Informatics to Address Social Determinants of Health During Clinical Care Visits to Promote Behavior Change and PREVENT Cardiovascular Disease

A study testing PREVENT tool in people with Cardiovascular Diseases and Obesity, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Cardiovascular Diseases, Obesity
What is being tested?
PREVENT tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
1 Jun 2020to 31 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Aged 12-17 years at baseline
  • at risk for poor CVH (body mass index >= 85th percentile)
  • Receiving care from the Healthy Start Clinic at Barnes Jewish Hospital.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University in St. Louis

    St Louis, Missouri, 63130

Other trials in United States

About this study

Healthcare providers recognize the need for behavior change and the influence of social determinants on youth at risk for poor cardiovascular health (CVH), especially among those of low-socioeconomic status (SES). Yet, providers lack the time and community data necessary to provide tailored, evidence-based care within routine practice. This project will use an Interventional Informatics approach to help providers prescribe patient-centered, evidence-based physical activity and nutrition prescriptions and link patients to community resources to account for social determinants at the point-of-care. This project will integrate our existing, novel, Patient-centered Real-timE interVENTion (PREVENT) tool into the BJC electronic health record (EHR) and test it with providers and adolescent patients at-risk for poor CVH. EHR integration of PREVENT will enable a cyclical, synergistic and data-centric approach to impact modifiable risk factors (physical activity and food intake) and prevent cardiovascular disease. This approach uses health informatics technology (HIT) to deliver data-driven, patient-centered care and generate evidence to support the use of HIT as a way to prevent cardiovascular disease across diverse patients and communities.

Being tested
PREVENT tool, Wait-list Control
Medical subject headings
Cardiovascular Diseases, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PREVENT toolBehavioural

    PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese 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.

  • Wait-list ControlBehavioural

    Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool

Study groups in NCT06121193
Study groupRoleWhat they receive
Patients - Wait-List ControlActive comparatorComplete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered at 3-months after the clinic visit electronically and by mail. • A PREVENT action plan (behavior change prescription, community resources, and education) will be provided to the patient via email after the completion of the follow-up measurement.
Receives: Behavioral: Wait-list Control
Experimental: Patients - PREVENT ToolExperimentalComplete questionnaires at baseline (administered electronically or by mail). Follow-up measures will be administered immediately following the clinic visit, and monthly for 3-months after the clinic visit electronically and by mail • At the clinic visit, the provider will use the PREVENT tool to discuss CVH risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources.
Receives: Behavioral: PREVENT tool
ProvidersNo intervention-All eligible providers will be sent questionnaires electronically to their email at baseline, following provider training and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients' satisfaction of PREVENT tool: survey

    A survey (6-questions) will assess patient's satisfaction with the PREVENT tool. Questions are asked on a 5-point Likert scale (range: 6-30) with a higher score indicating greater satisfaction.

    Measured: 3-months

  2. Provider's satisfaction of PREVENT tool: survey

    A survey (31-questions) will assess provider's acceptability and satisfaction with five aspects of health information technology: content, accuracy, format, ease of use and timeliness. Questions are asked on a 5-point Likert scale (range: 31-155) with a higher score indicating greater satisfaction.

    Measured: 3-months

  3. Fidelity of PREVENT tool implementation

    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.

    Measured: 0-3 months

Secondary outcomes (8)

  1. Change in patient's motivation

    A survey (15-question) administered to patients will assess motivation and self-efficacy for behavior change. Questions are asked using a 4-point Likert scale (range: 15-60) with a higher score indicating greater motivation.

    Measured: At baseline, and 3-months

  2. Change in patient's knowledge of CVH

    A survey (3-question) administered to patients to assess their knowledge of CVH risk (perceived value/importance of healthy behaviors) and awareness of resources. Questions are asked using a 4-point Likert scale (range: 3-12) with a higher score indicating greater knowledge.

    Measured: At baseline, and 3-months

  3. Change in food intake behaviors

    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.

    Measured: At baseline, and 3-months

  4. Change in physical activity behaviors

    Patient-reported physical activity (minutes of moderate and vigorous activity per week) are collected using a survey (4-questions). Patients report the average number of minutes of moderate and vigorous activity they do per week.

    Measured: At baseline, and 3-months

  5. Change in body mass index z-score

    Collected from patient's medical record. BMI z-score was calculated using the Centers for Disease Control and Prevention Growth Charts. The mean change was calculated by subtracting the baseline mean from the follow-up mean for each intervention group.

    Measured: At baseline, and 3-months

  6. Change on patient's average systolic and diastolic blood pressure

    Collected from patient's medical record

    Measured: At baseline, and 3-months

  7. Change in patient's cholesterol

    Collected from patient's medical record

    Measured: At baseline, and 3-months

  8. Change in patient's blood glucose

    Collected from patient's medical record

    Measured: At baseline, and 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start1 Jun 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121193
Sponsor's protocol ID
202004230
Status last verified
Nov 2023
First submitted
1 Nov 2023
Last updated
9 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kepper M, Walsh-Bailey C, Miller ZM, Zhao M, Zucker K, Gacad A, Herrick C, White NH, Brownson RC, Foraker RE. The Impact of Behavior Change Counseling Delivered via a Digital Health Tool Versus Routine Care Among Adolescents With Obesity: Pilot Randomized Feasibility Study. JMIR Form Res. 2024 May 17;8:e55731. doi: 10.2196/55731.

    PubMed 38758581

Questions about this trial

What is this clinical trial studying?

A study testing PREVENT tool in people with Cardiovascular Diseases and Obesity, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients' satisfaction of PREVENT tool: survey (time frame: 3-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06121193, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.

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