Use of Track Health Function of the MyHealthevet Personal Health Record
Primary Purpose
Prediabetic State
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
patient health record
Sponsored by
About this trial
This is an interventional health services research trial for Prediabetic State focused on measuring lifestyle, patient health record, Veterans, prediabetes
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.
Sites / Locations
- Miami VA Healthcare System, Miami, FL
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient health record
Arm Description
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.
Outcomes
Primary Outcome Measures
Change From Baseline Weight
measured in lbs.
Body Mass Index
Measured in kg/m^2
Change From Baseline Abdominal Circumference
measured in inches
Change From Baseline Energy Expenditure
measured in kcal using an accelerometer
Change From Baseline Dietary Intake
24-hour dietary recall; the Nutrition Data System for Research used to compute kcal
Systolic and Diastolic Blood Pressure
Secondary Outcome Measures
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.
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.
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
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
Change in Patient Activation
A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation
Full Information
NCT ID
NCT02921425
First Posted
September 28, 2016
Last Updated
July 30, 2018
Sponsor
VA Office of Research and Development
Collaborators
Miami VA Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT02921425
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2014 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
September 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Miami VA Healthcare System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
lifestyle, patient health record, Veterans, prediabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient health record
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
patient health record
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline Weight
Description
measured in lbs.
Time Frame
Baseline, 3 months
Title
Body Mass Index
Description
Measured in kg/m^2
Time Frame
baseline, 3 months
Title
Change From Baseline Abdominal Circumference
Description
measured in inches
Time Frame
baseline, 3 months
Title
Change From Baseline Energy Expenditure
Description
measured in kcal using an accelerometer
Time Frame
baseline, 3 months
Title
Change From Baseline Dietary Intake
Description
24-hour dietary recall; the Nutrition Data System for Research used to compute kcal
Time Frame
baseline, 3 months
Title
Systolic and Diastolic Blood Pressure
Time Frame
baseline, 3 months
Secondary Outcome Measure Information:
Title
Change From Baseline Physical Activity Self-efficacy
Description
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.
Time Frame
baseline, 3 months
Title
Change From Baseline Diet Self-efficacy
Description
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.
Time Frame
baseline, 3 months
Title
Change in Intent to Perform Physical Activity
Description
A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity
Time Frame
baseline, 3 months
Title
Change in Intent to Adhere to Diet
Description
A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet
Time Frame
baseline, 3 months
Title
Change in Patient Activation
Description
A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation
Time Frame
baseline, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Sharit, PhD
Organizational Affiliation
Miami VA Healthcare System, Miami, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27920356
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.
Results Reference
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Use of Track Health Function of the MyHealthevet Personal Health Record
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