PAL2 for High Blood Pressure

Wayne Health, Detroit, MI
High Blood Pressure+2 More ConditionsPAL2 - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a novel intervention, PAL2, to see if it is more effective than usual care in reducing blood pressure and preventing stage 1 hypertension in 500 black adults with elevated blood pressure. The intervention is being delivered in deprived neighborhoods by community health workers using a personalized, adaptable approach. The trial will also assess the reach, adoption, sustainability and cost-effectiveness of LEAP-HTN at 12 and 24 months.

Eligible Conditions
  • High Blood Pressure
  • Cardiovascular Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Similar Trials

1
Blueberry Powder
1
Exercise Training effect on Hypertension and Gut Dysbiosis
1
CTC Intervention

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 24 months

12 Months
PAL2 (active) intervention will lower diastolic BP compared to usual care (control).
12 months
PAL2 (active) intervention will lower the incidence of stage-1 hypertension compared to the control group over 1 year
Systolic BP levels will be significantly lower (by ≥4 mm Hg) in participants randomized to the PAL2 (active) intervention versus usual care (control) over the first 12 months of the trial
24 months
The rates of adoption and sustainability of the PAL2 intervention will increase from baseline to 12 and 24 months, respectively.

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Blueberry Powder
1
Exercise Training effect on Hypertension and Gut Dysbiosis
1
CTC Intervention

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: PAL2 · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: PAL2 · Intervention Types: Behavioral
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
292 Previous Clinical Trials
104,443 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Michigan100.0%
What site did they apply to?
Wayne Health100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

Is it still possible for individuals to take part in this experiment?

"Affirmative. According to information on clinicaltrials.gov, this medical trial is currently enrolling patients - the study was initially posted in August 8th 2022 and its most recent update happened at September 29th of the same year. 500 participants are required for this experiment located within a single site." - Anonymous Online Contributor

Unverified Answer

How many participants are recruited for this trial?

"Affirmative. Current details on clinicaltrials.gov confirms this research is in the process of recruitment, having been launched on August 8th 2022 and edited most recently on September 29th 2022. The investigation requires 500 volunteers at a single medical facility to participate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top