Guided Physical Activity Counseling for Hypertension in Primary Care

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, San Diego

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physical activity counseling

    Behavioral

    The 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

330 Participants
are divided into 3 treatment groups
Group A: Physical Activity Counseling GuideExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Group C: Comparison: Fitbit Data OnlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
4 months

Secondary outcomes

1

Height in centimeters

Height in cm

Time frame
Recorded at ambulatory care visit (4-6 weeks post-enrollment)
2

Medication Use

Use and dose of medications per medical record

Time frame
4 months
3

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.

Time frame
4 months
4

Demographics (Patient)

Age, race, ethnicity, education, income, marital status

Time frame
Enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: