Clinical trial NCT05106036: Preventing Cognitive Decline by Reducing BP Target Trial
Official title: Preventing Cognitive Decline by Reducing BP Target Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Decline
Blood Pressure
Hypertension
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Duke University
name: Parkland Health and Hospital System
First posted: 2021-11-03
Enrollment: 4000
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The PCOT study is a multi-site randomized trial of patients 70 years or older with high BP. The main goal of the study Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) is to conduct a large pragmatic clinical trial (PCT) to test the hypothesis that patients who receive care with a combination of clinical decision support (CDS) and team-based care delivered in primary care practices will have better blood pressure control and a lower incidence of mild cognitive impairment and dementia than patients receiving usual medical care. Patients will be recruited from UT Southwestern Medical Center and Parkland Health \& Hospital System.

Detailed description: Aim 1 The main aim is to compare the effects of intensive BP intervention between the intervention and usual care arm on the rate of change in TICS-m per year. The investigators will recruit 4,000 patients over 70 years of age with BP \>130/80 mmHg from 2 diverse health systems and randomize patients within each health system to usual care or to a combination of care with clinical decision support, practice facilitators and Pharm Ds to lower home BP to \< 130/80 mmHg. The primary outcome of this trial will be development cognitive decline as determined by a decrease in TICS-m scores from baseline. As a secondary outcome, the investigators will also measure the development of mild cognitive impairment or dementia in a subset of patients who show a decline of ≥3 points through adjudication.

Aim 2a Determine the potential harms of intensive lowering BP. The investigators aim to recruit 4,000 study participants and compare the effects of lowering home BP below 130/80 mmHg with usual care on hospitalizations, emergency department visits, cardiovascular events, deaths, syncope, falls, fractures, hypotension, electrolyte abnormalities and acute kidney injury. The investigators will capture measures of adherence and health care resource utilization. The investigators will assess QOL in 4,000 patients. The investigators will capture possible harms of lowering BP below 130/80 mmHg. The investigators have chosen clinical outcomes of relevance to all the stakeholders based on prior experience on pragmatic clinical trials and our prior experience in ICD-Pieces. Outcomes will be captured from the telephone assessment by study personnel and electronic health records and/or claims data and reflecting possible harms from all participants will include hospitalizations, emergency department visits, cardiovascular events, deaths, syncope, hypotension, falls, fractures, electrolyte disturbances and acute kidney injury. There will also be capture of adherence by pharmacy refill data. The investigators will capture BP readings from each visit. The investigators will also capture number of encounters with the health system as a measure of health care utilization.

Aim 2b Determine the impact of intensive BP management on QOL. Determine the impact of intensive BP management on QOL. Quality of life (QOL) scores will be obtained using the PROMIS Scale v1.2 - Global Health instrument annually after the administration of the TICS-m.

Eligibility criteria: Inclusion Criteria:

* High BP defined as at least 1 BP readings of SBP \>= 130 or DBP \>=80 during the 24 months prior to enrollment
* Clinic visit with primary care provider within the last 24 months
* Ability to write and speak English or Spanish
* 70 years of age or older
* Ability to understand and willingness to provide informed consent
* Owns a smartphone

Exclusion Criteria:

* Blood pressure consistently \<130/80 mmHg
* Presence of dementia, Alzheimer's disease, or significant neurological disease
* 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
* Under 70 years of age
* Inability to write or speak English or Spanish
* Chronic kidney disease stage 5 or ESKD
* Chemotherapy
* Any conditions judged by the medical providers to contraindicate participation due to risk to patient safety or lack of adherence
* Expected life expectancy under a year

Primary outcomes:
measure: Cognitive Decline
timeFrame: 4 years
Secondary outcomes:
measure: Mild Cognitive Decline or Dementia
timeFrame: 4 years
Other outcomes:
measure: Number of Pharmacy Refills
timeFrame: 4 years
measure: Change in quality of life assessment
timeFrame: 4 years
measure: Number of encounters within the participant's health system
timeFrame: 4 years
measure: Systolic and Diastolic BP Readings
timeFrame: 4 years
measure: Combination Pill Use
timeFrame: 4 years
measure: BP Above 130/80
timeFrame: 4 years
measure: Count of individuals who experience any of the following safety events: hospitalizations and emergency room visits
timeFrame: 4 years
measure: Number of reported deaths
timeFrame: 4 years
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References: