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| Name | Class |
|---|---|
| Miami VA Healthcare System | FED |
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This study was a pilot 3-month clinical trial that investigated the feasibility, effectiveness, and acceptability of using the Track Health function of the Veterans Health Administration's patient health record for effecting a more positive physical activity (PA) and dietary intake lifestyle in a sample of 38 overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (e.g., weight) and subjective (e.g., self-efficacy).
This was a pilot clinical trial that used a single-group design to test the feasibility, effectiveness, and acceptability of using the Track Health (TH) function of My HealtheVet, the VA's patient health record (PHR), as a tool for effecting a more positive physical activity (PA) and dietary intake lifestyle in overweight and obese Veterans with prediabetes. Baseline and three-month post-intervention outcomes were measured in two main domains: objective (PA as measured by an accelerometer, diet, weight, abdominal circumference, BMI, and blood pressure) and subjective (self-efficacy, intent to adhere to lifestyle change, and patient activation). Assessments, including screening on inclusion and exclusion criteria, physiological measurements, administration of questionnaires, and training on use of two critical features of the TH function--the use of Journals to enter dietary and PA data and the use of Vitals + Readings to enter weight and track physiological measures--took place place across four visits to the study site, which was the Veterans Administration Medical Center in Miami. The investigators hypothesized that this PHR-based intervention would demonstrate improvements and increases, respectively in the objective and subjective domain measures. The investigators also hypothesized that engagement by study participants with MHV would be demonstrated through meeting target criteria regarding making entries into this PHR's TH function, and that participants would be satisfied with the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient health record | Experimental | The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient health record | Behavioral | The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- as a basis for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle and physiological outcome data. Participants were directed to enter food intake, PA, and weight information a specified number of times per week over the 3-month study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Weight | measured in lbs. | Baseline, 3 months |
| Body Mass Index | Measured in kg/m^2 | baseline, 3 months |
| Change From Baseline Abdominal Circumference | measured in inches | baseline, 3 months |
| Change From Baseline Energy Expenditure | measured in kcal using an accelerometer | baseline, 3 months |
| Change From Baseline Dietary Intake | 24-hour dietary recall; the Nutrition Data System for Research used to compute kcal | baseline, 3 months |
| Systolic and Diastolic Blood Pressure | baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Physical Activity Self-efficacy | an 18-item exercise self-efficacy questionnaire (confidence in one's ability to exercise) exercises); scale range: 0 - 100. Higher scores indicate increased self-efficacy. | baseline, 3 months |
| Change From Baseline Diet Self-efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Sharit, PhD | Miami VA Healthcare System, Miami, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami VA Healthcare System, Miami, FL | Miami | Florida | 33125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27920356 | Background | Sharit J, Idrees T, Andrade AD, Anam R, Karanam C, Valencia W, Florez H, Ruiz JG. Use of an online personal health record's Track Health function to promote positive lifestyle behaviors in Veterans with prediabetes. J Health Psychol. 2018 Apr;23(5):681-690. doi: 10.1177/1359105316681065. Epub 2016 Dec 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Health Record | The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet. Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Health Record | The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet. Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline Weight | measured in lbs. | Posted | Mean | Standard Deviation | lbs. | Baseline, 3 months |
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Adverse events were not monitored or assessed.
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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 | Patient Health Record | The study intervention involved the provision to study participants of targeted instruction and practice on use of the Track Health function of the VA's patient health record known as My HealthyVet. Patient health record: The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Sharit | University of Miami | 305-284-6472 | jsharit@miami.edu |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055991 | Health Records, Personal |
| ID | Term |
|---|---|
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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|
a single 7-point item questionnaire (confidence in one's ability to adhere to a healthy diet). Scale range: 1 - 7. Higher numbers indicate less self-efficacy. |
| baseline, 3 months |
| Change in Intent to Perform Physical Activity | A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity | baseline, 3 months |
| Change in Intent to Adhere to Diet | A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet | baseline, 3 months |
| Change in Patient Activation | A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation | baseline, 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Body Mass Index | Measured in kg/m^2 | Posted | Mean | Standard Deviation | kg/m^2 | baseline, 3 months |
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| Primary | Change From Baseline Abdominal Circumference | measured in inches | Posted | Mean | Standard Deviation | inches | baseline, 3 months |
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| Primary | Change From Baseline Energy Expenditure | measured in kcal using an accelerometer | Posted | Mean | Standard Deviation | kcal | baseline, 3 months |
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| Primary | Change From Baseline Dietary Intake | 24-hour dietary recall; the Nutrition Data System for Research used to compute kcal | Posted | Mean | Standard Deviation | kcal | baseline, 3 months |
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| Primary | Systolic and Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | baseline, 3 months |
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| Secondary | Change From Baseline Physical Activity Self-efficacy | an 18-item exercise self-efficacy questionnaire (confidence in one's ability to exercise) exercises); scale range: 0 - 100. Higher scores indicate increased self-efficacy. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months |
|
|
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| Secondary | Change From Baseline Diet Self-efficacy | a single 7-point item questionnaire (confidence in one's ability to adhere to a healthy diet). Scale range: 1 - 7. Higher numbers indicate less self-efficacy. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months |
|
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|
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| Secondary | Change in Intent to Perform Physical Activity | A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months |
|
|
|
| Secondary | Change in Intent to Adhere to Diet | A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months |
|
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| Secondary | Change in Patient Activation | A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months |
|
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| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 | Endocrine System Diseases |
| D008919 |
| Investigative Techniques |
| Title | Measurements |
|---|---|
|
| diastolic bp, 3 moths |
|
| Other |