Trial Outcomes & Findings for Use of Track Health Function of the MyHealthevet Personal Health Record (NCT NCT02921425)

NCT ID: NCT02921425

Last Updated: 2018-08-07

Results Overview

measured in lbs.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: Baseline, 3 months
• Results posted on: 2018-08-07

Participant Flow

Participant milestones

Measure	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. 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 -- 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
Overall Study STARTED	47
Overall Study Second Visit	47
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure

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. 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 -- 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

Overall Study Protocol Violation

9

Baseline Characteristics

Use of Track Health Function of the MyHealthevet Personal Health Record

Baseline characteristics by cohort

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Age, Continuous	57.7 years STANDARD_DEVIATION 7.7 • n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	29 Participants n=93 Participants
Region of Enrollment United States	38 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

measured in lbs.

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change From Baseline Weight baseline	225.0 lbs. Standard Deviation 36.3
Change From Baseline Weight 3 months	222.1 lbs. Standard Deviation 36.0

PRIMARY outcome

Timeframe: baseline, 3 months

Measured in kg/m^2

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Body Mass Index baseline	33.6 kg/m^2 Standard Deviation 3.9
Body Mass Index 3 months	33.4 kg/m^2 Standard Deviation 3.9

PRIMARY outcome

Timeframe: baseline, 3 months

measured in inches

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change From Baseline Abdominal Circumference 3 months	43.5 inches Standard Deviation 4.9
Change From Baseline Abdominal Circumference baseline	44.2 inches Standard Deviation 5.0

PRIMARY outcome

Timeframe: baseline, 3 months

measured in kcal using an accelerometer

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change From Baseline Energy Expenditure baseline	435.2 kcal Standard Deviation 208.5
Change From Baseline Energy Expenditure 3 months	483.8 kcal Standard Deviation 221.0

PRIMARY outcome

Timeframe: baseline, 3 months

24-hour dietary recall; the Nutrition Data System for Research used to compute kcal

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change From Baseline Dietary Intake baseline	1612.2 kcal Standard Deviation 598.3
Change From Baseline Dietary Intake 3 months	1525.0 kcal Standard Deviation 777.3

PRIMARY outcome

Timeframe: baseline, 3 months

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Systolic and Diastolic Blood Pressure systolic bp, baseline	131.5 mmHg Standard Deviation 16.6
Systolic and Diastolic Blood Pressure systolic bp, 3 months	124.0 mmHg Standard Deviation 13.7
Systolic and Diastolic Blood Pressure diastolic bp, baseline	89.2 mmHg Standard Deviation 10.9
Systolic and Diastolic Blood Pressure diastolic bp, 3 moths	81.0 mmHg Standard Deviation 12.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change From Baseline Physical Activity Self-efficacy baseline	57.4 units on a scale Standard Deviation 16.8
Change From Baseline Physical Activity Self-efficacy 3 months	56.4 units on a scale Standard Deviation 17.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change From Baseline Diet Self-efficacy baseline	1.9 units on a scale Standard Deviation 1.2
Change From Baseline Diet Self-efficacy 3 months	2.4 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: baseline, 3 months

A single 7-point item, ranging from 1 - 7, with lower values indicating increased intent to perform physical activity

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change in Intent to Perform Physical Activity baseline	2.1 units on a scale Standard Deviation 1.3
Change in Intent to Perform Physical Activity 3 months	2.6 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: baseline, 3 months

A single 7-point item, ranging from 1-7. Lower scores indicate an increased intent to adhere to diet

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change in Intent to Adhere to Diet baseline	2.0 units on a scale Standard Deviation 1.2
Change in Intent to Adhere to Diet 3 months	2.2 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline, 3 months

A 22-item scale that captures various domains of patient activation; scale range: 0 - 100, higher scores indicate greater activation

Outcome measures

Measure	Patient Health Record n=38 Participants 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. 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 -- 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
Change in Patient Activation baseline	67.5 units on a scale Standard Deviation 12.3
Change in Patient Activation 3 months	67.8 units on a scale Standard Deviation 14.5

Adverse Events

Patient Health Record

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Joseph Sharit

University of Miami

Phone: 305-284-6472

Email: jsharit@miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place