Clinical trial NCT02921425: Use of Track Health Function of the MyHealthevet Personal Health Record
Official title: Use of the Track Health Function of the MyHealtheVet Personal Health Record
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Keywords: lifestyle
patient health record
Veterans
prediabetes
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Miami VA Healthcare System
First posted: 2016-10-03
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline Weight
timeFrame: Baseline, 3 months
measure: Body Mass Index
timeFrame: baseline, 3 months
measure: Change From Baseline Abdominal Circumference
timeFrame: baseline, 3 months
measure: Change From Baseline Energy Expenditure
timeFrame: baseline, 3 months
measure: Change From Baseline Dietary Intake
timeFrame: baseline, 3 months
measure: Systolic and Diastolic Blood Pressure
timeFrame: baseline, 3 months
Secondary outcomes:
measure: Change From Baseline Physical Activity Self-efficacy
timeFrame: baseline, 3 months
measure: Change From Baseline Diet Self-efficacy
timeFrame: baseline, 3 months
measure: Change in Intent to Perform Physical Activity
timeFrame: baseline, 3 months
measure: Change in Intent to Adhere to Diet
timeFrame: baseline, 3 months
measure: Change in Patient Activation
timeFrame: baseline, 3 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami VA Healthcare System, Miami, FL
state: Florida
Study officials:
affiliation: Miami VA Healthcare System, Miami, FL
name: Joseph Sharit, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.