Use of Track Health Function of the MyHealthevet Personal Health Record

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Use of the Track Health Function of the MyHealtheVet Personal Health Record

Conditions
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Prediabetic State

Intervention / Treatment
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* Behavioral: patient health record


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veterans with diagnosis of prediabetes (HbA1c 5.7-6.4%, fasting plasma glucose 100-125 mg/dL or oral glucose tolerance test 140-199 mg/dL) English speaking Access to the Internet Body mass index (BMI) of 25-42 kg/m and a sedentary lifestyle (not being physically active three days per week for 20 minutes each time for the previous six months and not performing regular resistance exercise) Able to engage in a regular program of mild-to-moderate intensity physical activity but were not currently following a weight loss diet or participating in an intervention trial Exclusion Criteria: Cognitively impaired (Mini-Cog greater than or equal to 3) Depressed (PHQ-2 less than or equal to 3) Vision or hearing disorders Have been diagnosed with diabetes mellitus, uncontrolled hypertension, or cardiovascular disease Currently pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient health record<br>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. | Behavioral: patient health record<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lifestyle, patient health record, Veterans, prediabetes