- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02921425
Use of Track Health Function of the MyHealthevet Personal Health Record
July 30, 2018 updated by: VA Office of Research and Development
Use of the Track Health Function of the MyHealtheVet Personal Health Record
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33125
- Miami VA Healthcare System, Miami, FL
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline Weight
Time Frame: Baseline, 3 months
|
measured in lbs.
|
Baseline, 3 months
|
|
Body Mass Index
Time Frame: baseline, 3 months
|
Measured in kg/m^2
|
baseline, 3 months
|
|
Change From Baseline Abdominal Circumference
Time Frame: baseline, 3 months
|
measured in inches
|
baseline, 3 months
|
|
Change From Baseline Energy Expenditure
Time Frame: baseline, 3 months
|
measured in kcal using an accelerometer
|
baseline, 3 months
|
|
Change From Baseline Dietary Intake
Time Frame: baseline, 3 months
|
24-hour dietary recall; the Nutrition Data System for Research used to compute kcal
|
baseline, 3 months
|
|
Systolic and Diastolic Blood Pressure
Time Frame: baseline, 3 months
|
baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline Physical Activity Self-efficacy
Time Frame: 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. |
baseline, 3 months
|
|
Change From Baseline Diet Self-efficacy
Time Frame: 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.
|
baseline, 3 months
|
|
Change in Intent to Perform Physical Activity
Time Frame: baseline, 3 months
|
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
Time Frame: baseline, 3 months
|
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
Time Frame: baseline, 3 months
|
A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation
|
baseline, 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Joseph Sharit, PhD, Miami VA Healthcare System, Miami, FL
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2014
Primary Completion (Actual)
September 30, 2015
Study Completion (Actual)
September 30, 2015
Study Registration Dates
First Submitted
September 28, 2016
First Submitted That Met QC Criteria
September 30, 2016
First Posted (Estimate)
October 3, 2016
Study Record Updates
Last Update Posted (Actual)
August 7, 2018
Last Update Submitted That Met QC Criteria
July 30, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 13-135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.