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NCT Number: NCT07342543

Guided Physical Activity Counseling for Hypertension in Primary Care

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

There is robust evidence that adopting regular moderate-to-vigorous physical activity (MVPA) can improve blood pressure and reduce CVD risk in patients with hypertension. Accordingly, MVPA counseling is considered first line treatment for patients with pre- and stage 1 hypertension, though rates of counseling in ambulatory care visits for hypertension management remain low. Some health systems have begun incorporating data from wearable activity trackers (e.g., Fitbits) into electronic health records (EHR) to facilitate MVPA counseling, but it is unclear whether sharing these data with providers will change ambulatory care visits or patient behavior. Clinicians have reported myriad barriers to incorporating this technology into clinical care, including that reviewing data takes too much time, is not standardized, takes expertise they do not have, and there is often too much data to be useful. In addition to summarized data, providers may need guidance in how to interpret it, use evidence-based counseling practices, and suggest behavior change strategies based on patients' unique barriers. In the current proposal, investigators will conduct a 3-arm randomized trial to test the efficacy of an expert software system to interpret data from wearables for providers and generate tailored counseling scripts for them incorporating evidence-based communication strategies for primary care. The study team will recruit N=30 primary care providers from UC San Diego primary care clinics and N=300 of their patients with pre- and stage 1 hypertension (PS1H). All patients will receive a wearable Fitbit activity tracker to wear in the 4-6 weeks preceding an ambulatory care visit for PS1H management. Providers will be randomized to receive 1) algorithm-driven counseling guides in EHR with summarize data and tailored counseling scripts based on patient activity levels and barriers (intervention), 2) only summarized data from wearables integrated into EHR (comparison), or 3) no access to patient Fitbit data (control). Patients will continue to wear trackers continuously for 3 months following their ambulatory care visit, and will take at-home blood pressure readings monthly. Investigators hypothesize that patients whose providers are randomized to receive the expert system summary reports will show greater increases in MVPA following ambulatory care visits than those whose providers receive only summarized data and patients in the control group. The study team will also evaluate effects of the counseling guides on blood pressure, doctor-patient communication, and clinical workflow by using time stamps in EHR to estimate visit length. Investigators will also evaluate provider satisfaction with the system through questionnaires and interviews. This study will advance intervention science by creating an intervention tool for providers that has potential for low-cost implementation across a wide range of clinical settings. This will capitalize on the rich data that are increasingly generated by consumer wearables in clinical populations while addressing critical barriers to incorporating this data into clinical care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Providers:

  • 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

Inclusion criteria

for Patients:

  • 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
  • be currently engaging in <150 minutes/week of at least moderate intensity exercise (see below)
  • be between age 18 and 80 years
  • not currently taking anti-hypertensive medication
  • able to read, speak, and understand English.

Exclusion criteria

for Providers:

  • 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.

Exclusion criteria

for Patients:

  • any condition that would contraindicate unsupervised exercise as determined by their provider, such as severe cardiovascular or pulmonary disease limiting exercise tolerance
  • plans to change healthcare providers within the next two months
  • planned surgery or procedure that could impact mobility within the next five months
  • pregnancy.

Treatment and study plan

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.

Primary outcomes

  1. Change in Physical Activity Minutes Measured by Fitbit

    Time frame: 4 months

    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

  1. Height in centimeters

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

    Height in cm

  2. Medication Use

    Time frame: 4 months

    Use and dose of medications per medical record

  3. Blood Pressure (at-home)

    Time frame: 4 months

    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.

  4. Demographics (Patient)

    Time frame: Enrollment

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

  5. Rate Your Plate

    Time frame: 4 months

    a 24-item tool capturing information regarding fat intake, animal and dairy protein, fruit, vegetables, whole grains, snacks, and sweets.

  6. Social Support for Exercise (SSE)

    Time frame: 4 months

    Questionnaire measuring social support specifically in relation to exercise with three subscales (friends, family, rewards/punishments)

  7. Self-Efficacy for Physical Activity (SE)

    Time frame: 4 months

    Questionnaire measuring confidence to become physically active across diverse contexts

  8. Center for Epidemiologic Studies Depression Scale (CES-D)

    Time frame: 4 months

    20-item self reported questionnaire designed to measure depressive symptoms, with higher scores indicating possible depression

  9. Perceived Stress Scale (PSS)

    Time frame: 4 months

    A 10-item scale used to assess stress levels with higher scores indicating greater perceived stress

  10. Pittsburgh Sleep Quality Index

    Time frame: 4 months

    Questionnaire used to measure sleep quality

  11. After-visit Questionnaire

    Time frame: immediately following ambulatory care visit in clinic (4-6 weeks post-enrollment)

    Assesses which topics were discussed during provider visit, including physical activity, goals, behavior change techniques, wearable tracker data, etc.

  12. Communication and Shared Decision Making

    Time frame: immediately following ambulatory care visit in clinic (4-6 weeks post enrollment)

    the CollaboRATE questionnaire measuring patient experience of care, plus the facilitation subscale of the Perceived Involvement in Care scale

  13. Fitbit Adherence

    Time frame: 4 months

    % of days Fitbit worn, % of days Fitbit synced within 5 days

  14. Clinical Workflow

    Time frame: 2 months

    Timestamped user access logs in Epic to approximate visit lengths to assess if using the physical activity counseling guides impacts total visit timed

  15. Consumer Satisfaction Questionnaire (Provider)

    Time frame: 18-36 months post-enrollment

    Assess overall satisfaction/acceptability and suggestions for improvement (intervention arm only)

  16. Follow-up Interview (Provider)

    Time frame: 18-36 months post-enrollment

    A brief 20-minute interview to share experiences with the physical activity counseling guides (intervention arm) or summarized wearable data (comparison arm), and give suggestions for increased efficacy and usability

  17. Demographics (Provider)

    Time frame: At enrollment

    Age, sex, provider type/degree, specialty, years in clinical practice

  18. Weight in kg

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

    Weight measured in kilograms

  19. Resting blood pressure in clinic

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

    Blood pressure in mm Hg as measured in clinic

  20. Medication adherence

    Time frame: 4 months

    Medication Adherence Report Scale (MARS-5) is a 5-item questionnaire to assess self-reported adherence to medical regimens with higher scores indicating better adherence

Study contacts

Contact information is provided by the study sponsor or research team.

Britta Larsen, PhD

CONTACT

[email protected]

858-534-8429

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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