Use of Track Health Function of the MyHealthevet Personal Health Record

Not Applicable

Completed

• Conditions: Prediabetic State
• Interventions: Behavioral: patient health record

• Registration Number: NCT02921425
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-07-01
• Primary Completion: 2015-09-30
• Study Completion: 2015-09-30
• Study First Submitted: 2016-09-28
• Study First Submitted QC: 2016-09-30
• Study First Posted: 2016-10-03
• Results First Submitted: 2017-10-17
• Status Verified: 2018-07
• Results First Submitted QC: 2018-07-30
• Last Update Submitted: 2018-07-30
• Results First Posted: 2018-08-07
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient health record	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.

Primary Outcome Measures

Name	Time	Method
Body Mass Index	baseline, 3 months	Measured in kg/m\^2
Systolic and Diastolic Blood Pressure	baseline, 3 months
Change From Baseline Energy Expenditure	baseline, 3 months	measured in kcal using an accelerometer
Change From Baseline Dietary Intake	baseline, 3 months	24-hour dietary recall; the Nutrition Data System for Research used to compute kcal
Change From Baseline Weight	Baseline, 3 months	measured in lbs.
Change From Baseline Abdominal Circumference	baseline, 3 months	measured in inches

Secondary Outcome Measures

Name	Time	Method
Change in Intent to Perform Physical Activity	baseline, 3 months	A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity
Change in Intent to Adhere to Diet	baseline, 3 months	A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet
Change From Baseline Physical Activity Self-efficacy	baseline, 3 months	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.
Change From Baseline Diet Self-efficacy	baseline, 3 months	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.
Change in Patient Activation	baseline, 3 months	A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation

Trial Locations

Locations (1)

Miami VA Healthcare System, Miami, FL; 🇺🇸 Miami, Florida, United States