Guided Physical Activity Counseling for Hypertension in Primary Care

NCT ID: NCT07342543

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-01
• Study Completion Date: 2031-01-01

Brief Summary

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.

Detailed Description

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.

Conditions

Physical Activity; Hypertension; Prehypertension; Hypertension Grade I, Subgroup "Borderline" (WHO)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Physical Activity Counseling Guide

Providers randomized to this group will provide physical activity counseling to patients based on their wearable fitness tracker data. Counseling will be guided by an online tool that synthesizes the patient's unique data and provides effective counseling prompts based on the data.

Group Type: EXPERIMENTAL

Physical activity counseling

Intervention Type: 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.

Standard of care

Providers randomized to this group will provide patients with the standard of care for physical activity counseling.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Comparison: Fitbit Data Only

Providers randomly assigned to this group will have access to patients' Fitbit data but will not be provided with activity counseling prompts.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical activity counseling

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Currently work for UC San Diego Health, with a primary appointment in one of the eight primary care clinics

2. Conduct ambulatory care visits for blood pressure management with at least 20 patients with a diagnosis of pre- or stage 1 hypertension

1. Have received a diagnosis of pre- or stage 1 hypertension, and/or having SBP 120-139, DBP <89

2. be receiving care from one of the enrolled providers

3. be currently engaging in <150 minutes/week of at least moderate intensity exercise (see below)

4. be between age 18 and 80 years

5. not currently taking anti-hypertensive medication

6. able to read, speak, and understand English.

Exclusion Criteria

1. planning to leave UCSD Health in the next 18 months

2. participated in the co-design workshops to design the PACE system

3. being unwilling to be randomized to one of the three conditions.

1. any condition that would contraindicate unsupervised exercise as determined by their provider, such as severe cardiovascular or pulmonary disease limiting exercise tolerance

2. plans to change healthcare providers within the next two months

3. planned surgery or procedure that could impact mobility within the next five months

4. pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Britta Larsen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Britta Larsen, PhD

Role: CONTACT

blarsen@health.ucsd.edu

858-534-8429

Other Identifiers

811759

Identifier Type: -

Identifier Source: org_study_id