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| ID | Type | Description | Link |
|---|---|---|---|
| K12HL137942 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Providers | No Intervention |
| |
| Parents | No Intervention | -Semi-structured interviews | |
| Patients - Wait-List Control | Active Comparator |
|
|
| Patients - PREVENT tool | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wait-List Control | Other | -Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey |
| At baseline and 3-months |
| Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-months |
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Inclusion Criteria:
Patient Eligibility Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Maura Kepper, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Providers |
|
| FG001 | Parents | -Semi-structured interviews |
| FG002 | Patients - Wait-List Control |
|
| FG003 | Patients - PREVENT Tool |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Providers |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not collected on Parents. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change in Minutes of Moderate Physical Activity Per Week (From Self Report) Survey |
| Providers and parents were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | minutes/week | At baseline and 3-months |
From baseline through 6 months post-baseline.
Adverse events and all-cause mortality were not collected for providers or parents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Providers |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maura Kepper, Ph.D. | Washington University School of Medicine | 314-935-0142 | kepperm@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2022 | Jan 30, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2022 | Jan 30, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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|
| PREVENT Tool | Other | -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. |
|
| 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. | 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. | 0-3 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. | 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. | 3-months |
| Patient's Perceptions of Usability/Acceptability of PREVENT Tool | Semi-structured interviews with adolescent study participants (n=10). | 3-months |
| Parent's Perceptions of Usability/Acceptability of PREVENT Tool | Semi-structured interviews with parents/guardians (n=10) of study participants. | 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. | 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. | At baseline and 3-months |
| Impact of PREVENT Tool on Patient's Cholesterol | Collected from patient's medical record | At baseline and 3-months |
| Impact of PREVENT Tool on Patient's Fasting Blood Glucose | Collected from patient's medical record | 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. | 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). | 3-months |
| Did not complete follow-up |
|
| BG001 | Parents | -Semi-structured interviews |
| BG002 | Patients - Wait-List Control |
|
| BG003 | Patients - PREVENT Tool |
|
| BG004 | Total | Total of all reporting groups |
| Median |
| Full Range |
| years |
|
| Sex: Female, Male | Sex was not collected on Parents. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity was not collected on Parents. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was not collected on Parents. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Providers |
|
| OG001 | Parents | -Semi-structured interviews |
| OG002 | Patients - Wait-List Control |
|
| OG003 | Patients - PREVENT Tool |
|
|
|
| Primary | Mean Change in Minutes of Vigorous Physical Activity Per Week (From Self Report) Survey |
| Providers and parents were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | minutes/week | At baseline and 3-months |
|
|
|
| Primary | 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. | Providers and parents were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a 0-5 scale | At baseline and 3-months |
|
|
|
| Primary | 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. | Parents and patients were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 3-months |
|
|
|
| Primary | 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. | Data was not collected on this outcome measure as the study team was unable to consistently observe study visits due to COVID-19 restrictions. | Posted | 0-3 months |
|
|
| Secondary | 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. | Parents and patients were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 3-months |
|
|
|
| Secondary | 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. | Parents and patients were not evaluable for this outcome measure. | Posted | Count of Participants | Participants | 3-months |
|
|
|
| Secondary | 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. | Parents and patients were not evaluable for this outcome measure. | Posted | Count of Participants | Participants | 3-months |
|
|
|
| Secondary | Patient's Perceptions of Usability/Acceptability of PREVENT Tool | Semi-structured interviews with adolescent study participants (n=10). | Data was not collected on this outcome measure as the investigators were unable to successfully recruit patients for follow-up interviews over the phone. | Posted | 3-months |
|
|
| Secondary | Parent's Perceptions of Usability/Acceptability of PREVENT Tool | Semi-structured interviews with parents/guardians (n=10) of study participants. | Data was not collected for this outcome measure as the investigators were unable to successfully recruit parents for follow-up interviews over the phone. | Posted | 3-months |
|
|
| Secondary | 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. | Parents and providers were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | z-score | At baseline and 3-months |
|
|
|
| Secondary | 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. | Parents and providers were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | At baseline and 3-months |
|
|
|
| Secondary | Impact of PREVENT Tool on Patient's Cholesterol | Collected from patient's medical record | Data was not collected and outcome measure was dropped. | Posted | At baseline and 3-months |
|
|
| Secondary | Impact of PREVENT Tool on Patient's Fasting Blood Glucose | Collected from patient's medical record | Data was not collected and outcome measure was dropped. | Posted | At baseline and 3-months |
|
|
| Secondary | 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. | Parents and providers were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | At baseline and 3-months |
|
|
|
| Secondary | 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). | Parents and patients were not evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 3-months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Parents | -Semi-structured interviews | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Patients - Wait-List Control |
| 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Patients - PREVENT Tool |
| 0 | 12 | 0 | 12 | 0 | 12 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|