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Intensive Blood Pressure Control for Cognitive Decline (IMPACTS-MIND Trial)
Phase 3
Recruiting
Led By Katherine T Mills, PhD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to an average of 42 months
Awards & highlights
IMPACTS-MIND Trial Summary
This trial will test a strategy to lower blood pressure in order to cognitive decline in racial minority and low-income patients who have hypertension.
Who is the study for?
This trial is for men and women aged 40 or older, primarily over 60, with high blood pressure who are patients at certain primary care clinics. It focuses on underserved populations such as ethnic minorities and low-income groups. Pregnant women or those not using birth control are excluded, along with anyone unable to consent.Check my eligibility
What is being tested?
The study tests a stepped-care approach aiming for systolic blood pressure below 120 mmHg to slow cognitive decline in racial minority and low-income patients. The strategy could be expanded if successful in preventing cognitive issues related to high blood pressure.See study design
What are the potential side effects?
While the trial's description does not specify side effects, intensive blood pressure control can sometimes lead to dizziness, fainting, kidney problems or electrolyte imbalances due to lower than usual BP levels.
IMPACTS-MIND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to an average of 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to an average of 42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Net difference in mean change in cognitive decline
Secondary outcome measures
Net difference in mean change in MoCA score
Net difference in mean change in diastolic blood pressure
Net difference in mean change in executive function
+2 moreOther outcome measures
Difference in proportion of patients with adjudicated mild cognitive impairment (MCI) or probable dementia (exploratory outcome)
Health-related Quality of Life (HRQoL)
Side effects
IMPACTS-MIND Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The core component of the intervention is protocol-based treatment using the SPRINT intensive BP management algorithm. Implementation strategies include dissemination of SPRINT study findings, team-based collaborative care and shared-decision making, blood pressure audit and feedback, home blood pressure monitoring, and health coaching.
Group II: Enhanced Usual CareActive Control1 Intervention
Enhanced usual care will include an education session on the ACC/AHA hypertension guideline to providers and proper BP measurement to providers and staff at enhanced usual care clinics.Otherwise, no active intervention will take place, and all usual care clinics will follow their routine clinic practice.
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Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,005 Total Patients Enrolled
Tulane UniversityLead Sponsor
115 Previous Clinical Trials
225,582 Total Patients Enrolled
Wake Forest UniversityOTHER
190 Previous Clinical Trials
163,680 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The study is focused on helping people who have less access to healthcare because of their ethnicity, income, or where they live.Your blood pressure is too high (above 140/130 mmHg) even with medication.You are not already enrolled in another program to control high blood pressure.You have treated more than 200 patients with high blood pressure in the past year.You cannot participate if you are pregnant, planning to become pregnant soon, a woman who can become pregnant but not using birth control, or unable to understand and agree to the study.Qualifications needed for primary care clinics to participate in the study.Your medical records are stored electronically.Requirements for people who can participate in the study.I am 40 or older and get my primary care from a participating clinic.You cannot use the same healthcare provider, nurse, or pharmacist as another participant in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced Usual Care
- Group 2: Intervention
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the level of risk associated with the SPRINT intensive-treatment algorithm for patients?
"There is existing clinical evidence to support the safety of the Stepped-care protocol, which is why it was given a 3."
Answered by AI
How many people can join this particular clinical trial?
"That's right, the listing on clinicaltrials.gov says that 920 participants are being recruited from 1 centre. The trial was first posted on October 22nd, 2019 and updated most recently on May 2nd, 2022."
Answered by AI
Are there any unfilled slots for this research project?
"That is correct, the information available on clinicaltrials.gov says that the study is currently looking for patients that fit the eligibility criteria. The study was posted on October 22, 2019 and was last updated on May 2, 2022. Only 920 participants are needed for the study and it is being conducted at 1 site."
Answered by AI
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