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Clinical Support Tool for Preventing Cognitive Decline (PCOT Trial)

N/A
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Must not have
Major and unstable heart disease (e.g., acute heart failure (systolic or diastolic), acute on chronic heart failure (systolic or diastolic), acute coronary syndrome or cardiac arrest, liver or renal transplantation
Chronic kidney disease stage 5 or ESKD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Summary

This trial is testing whether a combination of clinical decision support and team-based care can help reduce blood pressure and prevent cognitive decline in elderly patients.

Who is the study for?
This trial is for people aged 70 or older with high blood pressure, defined as two readings of SBP >= 130 or DBP >=80 in the last 24 months. Participants must be able to communicate in English or Spanish, have visited a primary care provider within the last two years, and own a smartphone or tablet.Check my eligibility
What is being tested?
The PCOT study tests if patients receiving team-based care and using a clinical decision support tool have better blood pressure control and lower rates of mild cognitive impairment compared to those getting usual medical care.See study design
What are the potential side effects?
Since this trial involves non-drug interventions like clinical support tools and team-based care approaches rather than medications, traditional side effects are not applicable. However, there may be indirect effects related to changes in healthcare management.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have recent severe heart issues or organ transplants.
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I have advanced kidney disease or am on dialysis.
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I am younger than 70 years old.
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I have dementia, Alzheimer's, or a major neurological condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognitive Decline
Secondary outcome measures
Mild Cognitive Decline or Dementia
Other outcome measures
BP Above 130/80
Change in quality of life assessment
Combination Pill Use
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Home BP data will be averaged each month via OmronConnect app on the patients' smartphone, which is programmed to send home BP readings to MyChart via Apple or Google Health.Participants whose home blood pressure reading average is systolic ≥ 130 and diastolic ≥ 80 will trigger the CDS (Clinical Decision Support) tool to assist their physicians with their blood pressure management. Study Team will not be involved in treatment decision making, it will be determined by subject's treating physician. .
Group II: Usual Care ArmActive Control1 Intervention
Physicians will continue to make decisions about the participant's blood hypertension management as usual without the CDS tool.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,058 Previous Clinical Trials
1,051,123 Total Patients Enrolled
Duke UniversityOTHER
2,394 Previous Clinical Trials
3,055,486 Total Patients Enrolled
4 Trials studying Cognitive Decline
680 Patients Enrolled for Cognitive Decline
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,029,257 Total Patients Enrolled
35 Trials studying Cognitive Decline
23,441 Patients Enrolled for Cognitive Decline

Media Library

Clinical Support Decision Tool Clinical Trial Eligibility Overview. Trial Name: NCT05106036 — N/A
Cognitive Decline Research Study Groups: Usual Care Arm, Intervention Arm
Cognitive Decline Clinical Trial 2023: Clinical Support Decision Tool Highlights & Side Effects. Trial Name: NCT05106036 — N/A
Clinical Support Decision Tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05106036 — N/A
~1405 spots leftby Aug 2025
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