- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04797403
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control in Minimize Cognitive Decline (IMPACTS-MIND)
Effectiveness of Implementing an Intensive Blood Pressure Reduction Intervention on Cognitive Decline in Low-Income and Minority Hypertensive Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Erin Peacock, PhD
- Phone Number: 504-988-1075
- Email: epeacoc@tulane.edu
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University
-
Contact:
- Erin Peacock, PhD
- Phone Number: 504-988-1075
- Email: epeacoc@tulane.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria for Primary Care Clinics
- Predominantly managing underserved populations with health disparities (ethnic minorities, low-income groups, and residents of rural areas and inner cities).
- Having electronic medical record systems.
- Serving >200 hypertension patients (ICD-10-CM I10-I15) during the previous year.
- Not participating in other hypertension control programs
- Not sharing providers or nurses/pharmacists with other participating clinics.
Inclusion Criteria for Study Participants
- Men or women aged ≥40 years (2/3 of participants ≥60 years) who receive primary care from participating clinics.
- Systolic BP ≥ 140 mmHg at two screening visits for those not taking antihypertensive medication or systolic BP ≥ 130 mmHg at two screening visits for those taking antihypertensive medications
- Pregnant women, women planning to become pregnant in the near future, women of childbearing potential and not practicing birth control, and persons who cannot give informed consent will be excluded.
- No diagnosis of dementia at baseline
- Baseline MoCA score ≥ 10.
- No diagnosis of end-stage renal disease, defined as dialysis or transplantation
- Speak English as first language
- No plans to change to a primary healthcare provider outside of their clinic in the near future
- No individuals unlikely to complete the study, such as those who plan to move out of the study area in the near future and temporary migrant and homeless people
- No immediate family members are staff at their clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
No Intervention: Enhanced Usual Care
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net difference in mean change in cognitive decline
Time Frame: Baseline to an average of 42 months
|
The net difference in mean change of global cognitive composite z-score over an average 42 months between intervention and enhanced usual care groups
|
Baseline to an average of 42 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net difference in mean change in MoCA score
Time Frame: Baseline to an average of 42 months
|
Difference between the intervention and usual care group in mean change in Montreal Cognitive Assessment (MoCA) over an average 42 months.
|
Baseline to an average of 42 months
|
Net difference in mean change in executive function
Time Frame: Baseline to an average of 42 months
|
Difference between the intervention and usual care group in mean change in executive function composite z-score (calculated from average of z-scores from individual tests: DSC, Trails A & B, DST, Category Fluency) over an average 42 months.
|
Baseline to an average of 42 months
|
Net difference in mean change in memory function
Time Frame: Baseline to an average of 42 months
|
Difference between the intervention and usual care group in mean change in memory composite z-score (calculated from average of z-scores from individual tests: MoCA immediate & delayed word recall, HVLT-R immediate recall) over an average 42 months.
|
Baseline to an average of 42 months
|
Net difference in mean change in systolic blood pressure
Time Frame: Baseline to an average of 42 months
|
Difference between the intervention and usual care group in mean change in systolic blood pressure over an average 42 months.
|
Baseline to an average of 42 months
|
Net difference in mean change in diastolic blood pressure
Time Frame: Baseline to an average of 42 months
|
Difference between the intervention and usual care group in mean change in diastolic blood pressure over an average 42 months.
|
Baseline to an average of 42 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects
Time Frame: Baseline to an average of 42 months
|
Difference between the intervention and usual care group in frequency of side effects (collected via detailed questionnaire) over an average 42 months.
|
Baseline to an average of 42 months
|
Health-related Quality of Life (HRQoL)
Time Frame: Baseline to an average of 42 months
|
Difference between the intervention and usual care group in mean change in health-related quality of life (measured using the 12-Item Short Form Survey) over an average 42 months.
|
Baseline to an average of 42 months
|
Difference in proportion of patients with adjudicated mild cognitive impairment (MCI) or probable dementia (exploratory outcome)
Time Frame: Baseline to an average of 42 months
|
Difference in adjudicated MCI and probable dementia at the termination visit between the intervention and usual care group.
Based on pre-defined MoCA cutpoints, suspected cases of dementia/MCI will be randomly assigned to two adjudicators, blinded to treatment assignment, with expertise in dementia for review.
Data used in the adjudication will include all available cognitive test data, functional assessment, and additional data including demographic information and medical records.
|
Baseline to an average of 42 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Katherine T Mills, PhD, Tulane University
- Principal Investigator: Jeff D Williamson, MD, Wake Forest University
- Principal Investigator: Jiang He, MD, PhD, Tulane University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R61AG068481 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. Data will be prepared by the Study Data Coordinating Center and sent to the study's NIA Program Official for review prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, the investigators will offer, through our public access website, opportunities for outside investigators to collaborate with us using complete study data.
At the completion of the project, the investigators will make all intervention materials and procedure manuals available to the public according to the approved plan for making data and materials available to the scientific community, lay public, and the NIH.
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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