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Hypertension Care Strategies for Pregnancy (ACHIEVE Trial)

N/A

Waitlist Available

Led By Mary K Menard, MD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

ACHIEVE Trial Summary

This trial will test an approach to improve care for pregnant/post-partum patients with high BP. 20 NC clinics will be trained, coached, and make use of simulations for better recognition/treatment of severe hypertension. Data will be collected to see if results improve.

Who is the study for?

This trial is for prenatal care clinics in certain North Carolina counties with a high number of births, significant Medicaid or uninsured patients, and diverse demographics. Participants include clinic staff and pregnant/post-partum patients with severe hypertension. Medical residents are excluded.Check my eligibility

What is being tested?

The ACHIEVE strategy aims to improve blood pressure measurement accuracy, patient education on hypertension, and recognition/treatment of severe hypertension in pregnant/post-partum women at participating clinics compared to usual care.See study design

What are the potential side effects?

Since this study focuses on training healthcare providers rather than administering drugs or medical procedures directly to patients, there are no direct side effects associated with the interventions being tested.

ACHIEVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Normalized percentage of achieving the highest possible score for blood pressure measurement technique

Normalized percentage of achieving the highest possible score for documentation of delivery of patient education on hypertension.

Secondary outcome measures

Normalized percentage of achieving the highest possible score for recognition and response to actual episodes of severe HTN

Normalized percentage of achieving the highest possible score for recognition and response to simulated episodes of severe hypertension

ACHIEVE Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Implementation ArmActive Control1 Intervention

The Active Implementation Arm is comprised of the clinics that have started to receive the intervention, which is the ACHIEVE multi-component implementation strategy delivered by the Nurse Coordinators. All 20 clinics (divided into 3 Cohorts) move from the Usual Care Arm into the Active Implementation Arm in sequential order (six months apart).

Group II: Usual Care ArmPlacebo Group1 Intervention

The Usual Care Arm is comprised of the clinics that are not yet receiving the intervention. All 20 clinics participating in the study are in the Usual Care Arm until they begin the Active Implementation phase.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor

1,504 Previous Clinical Trials

4,183,662 Total Patients Enrolled

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

3,834 Previous Clinical Trials

47,306,635 Total Patients Enrolled

Duke UniversityOTHER

2,358 Previous Clinical Trials

3,416,069 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I qualify to join this research trial?

"To join this clinical trial, applicants must be aged between 0 and 99 with diagnosed hypertension. The research team is hoping to enroll approximately 4000 individuals in total."

Answered by AI

Does the protocol of this research accept individuals aged 70 and above?

"Those hoping to join this medical trial must fulfill the age criteria of 0 - 99. At present, there are 78 ongoing trials oriented towards minors and 759 specifically for seniors aged 65 or older."

Answered by AI

Are new participants actively being enrolled in this research?

"Unfortunately, the clinicaltrials.gov website states that this trial is not presently enrolling participants; it was first posted on October 1st 2023 and most recently revised on August 28th 2023. Nevertheless, there are a plethora of other medical trials currently open to prospective patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle

2023. "Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06002165.