Cardiovascular DiseaseNCT04530825
PREVENT Tool Study: Late Effects Clinic
A study testing PREVENT Tool in people with Cardiovascular Disease and Childhood Obesity, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Cardiovascular Disease, Childhood Obesity
- What is being tested?
- PREVENT Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2021to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Addressing Social Determinants of Health During Clinical Care Visits to Promote Equitable Behavior Change and PREVENT Cardiovascular Disease
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.
- Conditions
- Cardiovascular Disease, Childhood Obesity
- Being tested
- Wait-List Control, PREVENT Tool
- Medical subject headings
- Cardiovascular Diseases, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wait-List ControlOther
-Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool
PREVENT ToolOther
-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.
| Study group | Role | What they receive |
|---|---|---|
| Providers | No intervention | * All eligible providers will be sent questionnaires electronically to their email at baseline and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline * A subset of 5-10 providers will be recruited via email, at the baseline training,or by using snowball-sampling approach within the clinic to participate in qualitative in-depth interviews |
| Parents | No intervention | -Semi-structured interviews |
| Patients - Wait-List Control | Active comparator | * Complete questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail
* Up to 10 patients will also take part in semi-structured interviews
* 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: Other: Wait-List Control |
| Patients - PREVENT tool | Experimental | * Complete questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail
* Up to 10 patients will also take part in semi-structured interviews
* At the clinic visit, the provider will use PREVENT tool to discuss risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. PREVENT will calculate patient's overall risk for developing cardiovascular disease. Physical activity and food intake recommendations are tailored to current weight status and health behaviors using evidence-based recommendations. Receives: Other: PREVENT Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey
- Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior \& Attitudes Survey using questions from the International Physical Activity Questionnaire 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.
- Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
Measured: At baseline and 3-months
Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey
- Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior \& Attitudes Survey using questions from the International Physical Activity Questionnaire 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.
- Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
Measured: At baseline and 3-months
Mean Change in Number of Food Intake Behaviors Met
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.
Measured: At baseline and 3-months
Provider's Satisfaction of PREVENT Tool: Survey
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.
Measured: 3-months
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 (11)
Provider's Motivation for Sustained Use of PREVENT Tool
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.
Measured: 3-months
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool
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.
Measured: 3-months
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool
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.
Measured: 3-months
Patient's Perceptions of Usability/Acceptability of PREVENT Tool
Semi-structured interviews with adolescent study participants (n=10).
Measured: 3-months
Parent's Perceptions of Usability/Acceptability of PREVENT Tool
Semi-structured interviews with parents/guardians (n=10) of study participants.
Measured: 3-months
Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)
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.
Measured: At baseline and 3-months
Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure
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.
Measured: At baseline and 3-months
Impact of PREVENT Tool on Patient's Cholesterol
Collected from patient's medical record
Measured: At baseline and 3-months
Impact of PREVENT Tool on Patient's Fasting Blood Glucose
Collected from patient's medical record
Measured: At baseline and 3-months
Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change
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.
Measured: At baseline and 3-months
Clinic-level Capacity for Sustainability as Measured by Provider Survey
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).
Measured: 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start10 Feb 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Maura Kepper, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530825
- Sponsor's protocol ID
- 202007026
- Other IDs
- K12HL137942
- Status last verified
- Apr 2023
- First submitted
- 11 Aug 2020
- Last updated
- 25 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Determinants of Health During Clinical Care Visits to Promote Equitable Behavior Change and PREVENT Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04530825
- Acronym / sponsor ID
- 202007026
- Conditions
- Cardiovascular Disease, Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Posted 25 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Providers | No intervention | –* All eligible providers will be sent questionnaires electronically to their email at baseline and follow-up. Providers will be invited to attend a training session to educate them on the PREVENT tool at baseline * A subset of 5-10 providers will be recruited via email, at the baseline training,or by using snowball-sampling approach within the clinic to participate in qualitative in-depth interviews |
| Parents | No intervention | –-Semi-structured interviews |
| Patients - Wait-List Control | Active comparator | Other: Wait-List Control* Complete questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail * Up to 10 patients will also take part in semi-structured interviews * 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. |
| Patients - PREVENT tool | Experimental | Other: PREVENT Tool* Complete questionnaires at baseline (administered electronically or by mail; accelerometers administered by mail). Following baseline measurement, patients will be randomized and attend their clinic visit. Follow-up measures will be administered immediately following the clinic visit (within 48 hours) and 3-months after the clinic visit electronically and by mail * Up to 10 patients will also take part in semi-structured interviews * At the clinic visit, the provider will use PREVENT tool to discuss risk and deliver a tailored behavioral change plan inclusive of patient-centered community resources. PREVENT will calculate patient's overall risk for developing cardiovascular disease. Physical activity and food intake recommendations are tailored to current weight status and health behaviors using evidence-based recommendations. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wait-List Control-Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool | Other | Patients - Wait-List Control |
| PREVENT Tool-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. | Other | Patients - PREVENT tool |
Primary outcome
Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey
Time frame: At baseline and 3-months
* Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior \& Attitudes Survey using questions from the International Physical Activity Questionnaire 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. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey
Time frame: At baseline and 3-months
* Physical activity will be measured using a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days, including 2 weekend days. Participants completed a brief Health Behavior \& Attitudes Survey using questions from the International Physical Activity Questionnaire 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. * Note: Actigraph measure was dropped due to university mail distribution delays during the remote work period of the COVID-19 pandemic. Self-reported change in minutes of physical activity became the primary outcome.
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.
Provider's Satisfaction of PREVENT Tool: Survey
Time frame: 3-months
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.
Fidelity of PREVENT Tool Implementation
Time frame: 0-3 months
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.
11 secondary outcomes
Provider's Motivation for Sustained Use of PREVENT Tool
Time frame: 3-months
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Feasibility of the Tool
Time frame: 3-months
Maintenance of PREVENT Tool as Measured by Provider Perceptions of Ease of Use of the Tool
Time frame: 3-months
Patient's Perceptions of Usability/Acceptability of PREVENT Tool
Time frame: 3-months
Parent's Perceptions of Usability/Acceptability of PREVENT Tool
Time frame: 3-months
Impact of PREVENT Tool on Mean Change in Patient's Body Mass Index (BMI)
Time frame: At baseline and 3-months
Impact of PREVENT Tool on Patient's Systolic and Diastolic Blood Pressure
Time frame: At baseline and 3-months
Impact of PREVENT Tool on Patient's Cholesterol
Time frame: At baseline and 3-months
Impact of PREVENT Tool on Patient's Fasting Blood Glucose
Time frame: At baseline and 3-months
Impact of PREVENT Tool on Patient's Attitudes Toward Behavior Change
Time frame: At baseline and 3-months
Clinic-level Capacity for Sustainability as Measured by Provider Survey
Time frame: 3-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maura Kepper, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREVENT Tool in people with Cardiovascular Disease and Childhood 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 9 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 25 Apr 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?
Yes. Results are posted in the registry (first posted 25 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey (time frame: At baseline and 3-months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2023.