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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
PCOT Trial 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.
PCOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
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 morePCOT 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.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,049,775 Total Patients Enrolled
Duke UniversityOTHER
2,363 Previous Clinical Trials
3,416,486 Total Patients Enrolled
4 Trials studying Cognitive Decline
680 Patients Enrolled for Cognitive Decline
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,016,925 Total Patients Enrolled
32 Trials studying Cognitive Decline
19,089 Patients Enrolled for Cognitive Decline
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had high blood pressure readings in the last 2 years.I have seen my primary care doctor in the last 2 years.I do not have recent severe heart issues or organ transplants.I am currently undergoing or have undergone chemotherapy.Your doctors believe you have less than a year to live.I have advanced kidney disease or am on dialysis.I am younger than 70 years old.I have dementia, Alzheimer's, or a major neurological condition.I am 70 years old or older and can understand and agree to the study's procedures.You have a smartphone or tablet.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care Arm
- Group 2: Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 size of the patient pool enrolled in this clinical experiment?
"Yes, the latest information from clinicaltrials.gov demonstrates that this experiment is currently searching for participants. Initially posted on July 11th 2022 and updated most recently on August 29th 2022, it requires 4000 patients to be recruited from a single site."
Answered by AI
Are there vacancies open for volunteers to take part in this research?
"As of the latest update on August 29th, 2022 this clinical trial is still seeking participants. This medical study was first posted to clinicaltrials.gov on July 11th, 2022."
Answered by AI
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