Use of Track Health Function of the MyHealthevet Personal Health Record

Prediabetic State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921425
• Other study ID #: PPO 13-135
• Status: Completed
• Phase: N/A
• Start date: July 1, 2014
• Est. completion date: September 30, 2015

Study information

• Verified date: July 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Behavioral:
• 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 -- 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.

Locations

Country	Name	City	State
United States	Miami VA Healthcare System, Miami, FL	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Miami VA Healthcare System

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

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