Prediabetic StateNCT02921425
Use of Track Health Function of the MyHealthevet Personal Health Record
A study testing patient health record in people with Prediabetic State, run by VA Office of Research and Development at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prediabetic State
- What is being tested?
- patient health record
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2014to 30 Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
About this study
Official title: 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).
Read the 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.
- Conditions
- Prediabetic State
- Being tested
- patient health record
- Keywords
- lifestyle, patient health record, Veterans, prediabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient health recordBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| patient health record | Experimental | 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. Receives: Behavioral: patient health record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Weight
measured in lbs.
Measured: Baseline, 3 months
Body Mass Index
Measured in kg/m^2
Measured: baseline, 3 months
Change From Baseline Abdominal Circumference
measured in inches
Measured: baseline, 3 months
Change From Baseline Energy Expenditure
measured in kcal using an accelerometer
Measured: baseline, 3 months
Change From Baseline Dietary Intake
24-hour dietary recall; the Nutrition Data System for Research used to compute kcal
Measured: baseline, 3 months
Systolic and Diastolic Blood Pressure
Measured: baseline, 3 months
Secondary outcomes (5)
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.
Measured: baseline, 3 months
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.
Measured: baseline, 3 months
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
Measured: baseline, 3 months
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
Measured: baseline, 3 months
Change in Patient Activation
A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start1 Jul 2014
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Miami VA Healthcare System
- Responsible party
- Sponsor
- Investigators
- Joseph Sharit, PhD, Principal investigator, Miami VA Healthcare System, Miami, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921425
- Sponsor's protocol ID
- PPO 13-135
- Status last verified
- Jul 2018
- First submitted
- 28 Sep 2016
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 27920356
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Track Health Function of the MyHealtheVet Personal Health Record
- ClinicalTrials.gov ID
- NCT02921425
- Acronym / sponsor ID
- PPO 13-135
- Conditions
- Prediabetic State
- Keywords
- lifestyle, patient health record, Veterans, prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Miami VA Healthcare System
- Study start
- 1 Jul 2014 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient health record | Experimental | Behavioral: patient health recordThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient health recordThe 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. | Behavioural | patient health record |
Primary outcome
Change From Baseline Weight
Time frame: Baseline, 3 months
measured in lbs.
Body Mass Index
Time frame: baseline, 3 months
Measured in kg/m^2
Change From Baseline Abdominal Circumference
Time frame: baseline, 3 months
measured in inches
Change From Baseline Energy Expenditure
Time frame: baseline, 3 months
measured in kcal using an accelerometer
Change From Baseline Dietary Intake
Time frame: baseline, 3 months
24-hour dietary recall; the Nutrition Data System for Research used to compute kcal
Systolic and Diastolic Blood Pressure
Time frame: baseline, 3 months
5 secondary outcomes
Change From Baseline Physical Activity Self-efficacy
Time frame: baseline, 3 months
Change From Baseline Diet Self-efficacy
Time frame: baseline, 3 months
Change in Intent to Perform Physical Activity
Time frame: baseline, 3 months
Change in Intent to Adhere to Diet
Time frame: baseline, 3 months
Change in Patient Activation
Time frame: baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27920356Sharit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Sharit, PhD principal investigator
Miami VA Healthcare System, Miami, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient health record in people with Prediabetic State, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Weight (time frame: Baseline, 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.