Personalized Activation Letter for High Blood Pressure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English speakers, Provider opt-out

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of personalized letters in helping people with high blood pressure achieve their health goals more quickly. Participants will receive either a personalized letter with medication suggestions (BP Activate Letter), a general letter recommending a doctor visit, or no letter at all. The trial aims to determine which approach encourages patients to visit their doctors sooner and adjust their medications as needed. It suits individuals with high blood pressure readings whose doctors participate in the study. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative strategies for managing high blood pressure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on adjusting your blood pressure medication, so you might continue with your current meds while possibly adding or changing your blood pressure treatment.

What prior data suggests that this protocol is safe for participants?

Research has shown that the BP Activate Letter safely helps manage high blood pressure. This method involves sending patients a letter with personalized medication advice, encouraging them to discuss potential medication changes with their doctors.

Receiving the letter poses no risk. The main aim is to determine if the letter helps patients control their blood pressure more effectively. Since this method involves only communication, no known side effects or negative outcomes result from the letter.

The letter suggests possible medication changes, which a doctor will review. Healthcare professionals will handle any medication changes to ensure safety. Therefore, participating in a trial with the BP Activate Letter is generally considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Activation Letter for high blood pressure because it offers a novel approach to managing the condition by empowering patients with personalized information. Unlike traditional methods that rely on medication adjustments made solely by healthcare providers, this approach uses a BP Activate Letter to provide patients with algorithm-based recommendations for medication changes. This encourages patients to actively engage in discussions with their clinicians about their treatment. The potential for this method to increase patient involvement and optimize treatment effectiveness makes it a promising innovation in the management of high blood pressure.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research shows that personalized letters to patients can improve blood pressure management. In past studies, people who received a letter with specific medication advice had lower blood pressure. For instance, one study found that average blood pressure dropped from 151/83 mm Hg to 137/79 mm Hg over six months. In this trial, participants in the BP Activate Letter arm will receive a personalized letter with computerized algorithm recommendations for medication changes to discuss with their clinician. Adding a personal touch, like the BP Activate Letter, helps patients and their doctors adjust medications more quickly and effectively. This method can lead to better blood pressure control and faster achievement of health goals. ^{2 6 7 8 9}

Who Is on the Research Team?

Mark Pletcher, MD MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for primary care patients with high blood pressure (SBP>140 or DBP>90) seen in a general internal medicine clinic within the last 2 years, where medication intensification is needed. It's not for those who don't speak English or whose provider opts them out.

Inclusion Criteria

Lowest SBP>140 or lowest DBP>90 at last visit in general internal medicine clinic

Patient is a primary care patient of a clinician in a general internal medicine clinic who has agreed to have their patients participate in the study

Last visit in general internal medicine clinic was < 2 years ago

Exclusion Criteria

Primary language is not English

Patient's provider indicates (through an active opt-out process) that they do not want the patient to receive a BP Activate letter

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either the BP Activate Report Letter, Control Letter, or no intervention

6 months

Participants are encouraged to schedule a visit with their provider

Follow-up

Participants are monitored for time to medication change or BP control

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BP Activate Letter
• Control Letter

Trial Overview The study compares the effectiveness of personalized BP Report letters recommending medication changes to Control letters and no intervention, measuring how quickly patients schedule appointments, visit clinics, change medications, and reach their BP goals.

How Is the Trial Designed?

Group I: BP Activate Letter Experimental Treatment 1 Intervention

Participants in the BP Activate Letter arm will receive a BP Report letter that includes computerized algorithm recommendations for medication changes they should discuss with their clinician.

Group II: Control Letter Active Control 1 Intervention

Participants in the Control Letter arm will receive a Control letter suggesting they talk to their clinician about their blood pressure (without BP history or specific medication recommendations).

Group III: Usual Care Active Control 1 Intervention

Participants in the Usual Care arm will not receive any letter or any other intervention.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06152094

NCT06152094 | UCSF BP Activate Letter Study The BP Activate Study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control letters ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2718089

Efficacy of Patient Activation Interventions With or Without ... For the control group, mean BP was 151.0/83.4 mm Hg at enrollment, 140.8/81.0 mm Hg at the index visit, and reduced to 137.7/79.3 mm Hg at the 6 ...

3. ucsfhealthdgim.ucsf.edu ucsfhealthdgim.ucsf.edu/sites/ucsfhealthdgim.ucsf.edu/files/inline-files/bp-activate_0.pdf

BP Activate project summary+ Protocol 1) This study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control letters and no ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30646291/

Efficacy of Patient Activation Interventions With or Without ... Adding a financial incentive and telephone call to the letter resulted in incremental improvements in both outcomes. By 12 months, improved BP ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.117.004386

Adapting and Evaluating a Health System Intervention ... Effectiveness of Mailed Patient Activation Letters for Blood Pressure Control: A Randomized Quality Improvement Trial, Journal of General ...

6. link.springer.com link.springer.com/article/10.1007/s11606-025-09946-0

Effectiveness of Mailed Patient Activation Letters for Blood ... We aimed to compare the effectiveness of this mailed intervention (BP Activate Letter) to a simpler Control Letter and to usual care (No Letter) ...

7. withpower.com withpower.com/trial/phase-hypertension-6-2023-042d7

Personalized Activation Letter for High Blood Pressure The BP Activate Study aims to assess the effectiveness of the BP Report letter with personalized BP medication recommendations, compared with Control ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2969841/

A Web-Based Patient Activation Intervention to Improve ... The primary outcome of the study is change in blood pressure and change in the percentage of patients in each group with controlled blood pressure. Conclusion.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9239484/

Integration of a multicomponent intervention for ... A greater percentage of participants achieved BP control at 24 months in the intervention (61.3%) arm versus usual care (51.2%) with associated odds ratio (95% ...