About this trial
The goal of this study is to create easy-to-read physical activity reports and counseling guides for primary care doctors. These tools will use activity data collected over time from wearable fitness trackers. The study will also test how helpful and easy the system is for doctors when talking with patients who have high blood pressure. This approach uses technology that already exists and helps solve problems that make it hard to use in medical care. It also has the potential to reach many people and be low-cost for clinics to use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently work for UC San Diego Health, with a primary appointment in one of the eight primary care clinics
Conduct ambulatory care visits for blood pressure management with at least 20 patients with a diagnosis of pre- or stage 1 hypertension
Have received a diagnosis of pre- or stage 1 hypertension, and/or having SBP 120-139, DBP <89
be receiving care from one of the enrolled providers
Disqualifiers
planning to leave UCSD Health in the next 18 months
participated in the co-design workshops to design the PACE system
being unwilling to be randomized to one of the three conditions.
any condition that would contraindicate unsupervised exercise as determined by their provider, such as severe cardiovascular or pulmonary disease limiting exercise tolerance
Trial design
Parallel
Treatments tested in this trial
Physical activity counseling
BehavioralThe personalized data system will use physical activity data from Fitbits to create summary system reports that will guide brief discussions between providers and patients regarding PA during clinic visits. To facilitate discussion, tailored guides for providers randomly assigned to the Intervention Arm will include each of the following elements: a) a visual summary of mean weekly minutes of MVPA over the past 4-6 weeks, b) whether they are meeting clinical guidelines of 150 minutes/week, c) whether their minutes are increasing, decreasing, or generally remaining the same, d) a script for performance feedback, e) questions tailored to whether the patient is increasing or decreasing their activity, f) a script to discuss an appropriate BCT through the lens of shared decision making, and g) a prompt to review the plan. The plan summary will be incorporated in the patient's after visit summary.
Treatment groups
Trial outcomes
Primary outcomes
Change in Physical Activity Minutes Measured by Fitbit
Change in physical activity minutes measured by wrist-worn Fitbits in patients who that are assigned to providers receiving the PACE Guides during ambulatory care visits (intervention group) compared to those seeing providers in the comparison or control groups.
Secondary outcomes
Height in centimeters
Height in cm
Medication Use
Use and dose of medications per medical record
Blood Pressure (at-home)
Patients will be sent an Omron M10-IT blood pressure cuff for monthly at-home readings. They will be provided with detailed instructions and a link to an AHA video demonstrating proper measurement. Participants will measure BP twice, one minute apart, in a seated position after 5 minutes of rest. They will be instructed to measure at the same time of day each month, and to avoid caffeine or physical activity immediately before measurement. Readings will be shared via Bluetooth and recorded in a log.
Demographics (Patient)
Age, race, ethnicity, education, income, marital status
Locations
Sponsors and contacts
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University of California, San Diego
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
This trial is not recruiting at the moment. You can still explore other options: