Telehealth-Enhanced Assessment and Management

Blood Pressure Clinical Trial

— TEAMS-BP  

Official title:

Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure (TEAMS-BP)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06247254
• Other study ID #: Bushnell
• Secondary ID: 2020C3-21070
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: July 2028

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Cheryl Bushnell, MD
• Phone: 336-713-7788
• Email: cbushnel[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TEAMS-BP is a Patient-Centered Outcomes Research Institute (PCORI)-funded trial under the Phased Large Awards for Comparative Effectiveness Research (PLACER) funding mechanism to evaluate two comprehensive and evidence-based strategies for managing blood pressure (BP) following stroke.

Description:

Hypertension affects nearly half of the US population (46% of adults) and is the strongest risk factor for recurrent stroke. Prevalence in patients with ischemic or hemorrhagic stroke in the US varies by region (highest in the South) ranging from 70% to 82%, and is associated with greater risk of recurrent stroke, major cardiovascular events, and death. A vital question for stroke patients and caregivers is how to prevent a recurrent stroke and further adverse events. Multiple clinical trials have shown that lowering BP reduces the risk for cardiovascular disease and stroke. Few trials, however, included stroke patients with a focus on secondary prevention nor were representative of vulnerable populations. The former US Surgeon General recently published a Call to Action focused on BP with three goals: 1) make hypertension control a national priority; 2) ensure that communities support hypertension control; and 3) optimize patient care for hypertension control.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1550
• Est. completion date: July 2028
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of ischemic stroke defined as acute brain, spinal cord, or retinal infarction based on objective evidence on imaging (such as a focal area of restricted diffusion on Magnetic Resonance Imaging [MRI]) in a defined vascular distribution or clinical evidence of focal ischemic injury based on symptoms persisting > 24 hours; or spontaneous hemorrhagic stroke defined as a focal collection of blood within the brain parenchyma that is non-traumatic and identified by brain computed tomography (CT) or brain MRI

• Age =18 years

• Discharged directly home from acute care or inpatient rehabilitation

• At least one of the following: documented history of hypertension; self-reported history of hypertension; use of

• hypertension medications (either prescribed prior to stroke, administered during hospital stay, or prescribed at discharge)

• Systolic Blood Pressure = 130 mmHg

• Able to read and understand English or Spanish,

• Have access to a functioning smartphone or tablet with broadband access

• Willing to install and use a study-compatible physical activity monitoring application on their smartphone or tablet or smartphone or tablet of a qualifying caregiver

• Stated agreement to participate in either intervention to which they are assigned and attend all required study visits,

• Consent to receiving Short Message Service (SMS) required as part of the study interventions

• Consent to enrollment in Chronic Care Management required as part of the study interventions,

• Provision of a signed and dated informed consent form

Exclusion Criteria:

• Subdural hematoma or subarachnoid hemorrhage

• Current participation in another stroke clinical trial precluding dual enrollment

• Presence of terminal illness, such as cancer, that limits life expectancy to <1 year

• Diagnosis of end-stage renal disease defined as permanent kidney dysfunction requiring the use of hemodialysis or peritoneal dialysis

• Pregnancy, lactation or planning to become pregnant

• Late-stage Alzheimer's disease or related dementia

• Transitioned to a facility such as skilled nursing or long-term care prior to enrollment

• Mid upper arm circumference > 45 cm/17.7 inches or < 22 cm / 8.66 inches

• Missing values for Systolic Blood Pressure or Privileged Access Management (PAM) score at baseline

• Any condition that in the opinion of the study investigator would preclude the participant from being able to safely participate in the trial

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Behavioral:
• Intensive Clinic Management
The ICM arm includes BP management at in-person follow-up visits occurring every 2 months when BPs are at target and if not in target, monthly visits. Medications will be adjusted to lower BP to the target using evidence-based guidelines and in the context of whether the participant can effectively manage their medications and BP. ICM participants will receive a COMPASS Care plan, which will evaluate social and functional factors for managing stroke recovery.
• Intensive Tailored Telehealth Management
The ITTM intervention involves a comprehensive, multi-dimensional approach to using real-time BP data to manage BP after stroke. ITTM includes an in-person visit during which participants will complete a series of questionnaires within the COMPASS-CP® web application and will receive a COMPASS-BP Action Plan home safety checklist, BP Matters documents, and referrals to local resources, as needed.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patient activations for Blood Pressure (BP) management - among Black/African-Americans	Number of patient activations for Blood Pressure (BP) management - among Black/African-Americans	Month 12
Other	Number of patient activations for Blood Pressure (BP) management - among patients with physical or cognitive post-stroke disability	Number of patient activations for Blood Pressure (BP) management - among patients with physical or cognitive post-stroke disability	Month 12
Other	Number of patient activations for Blood Pressure (BP) management - among older adults (age 75+)	Number of patient activations for Blood Pressure (BP) management - among older adults (age 75+)	Month 12
Other	Change in Morisky Green Levine Medication Adherence Scale Scores	Medication adherence, as assessed by the Morisky Green Levine Medication Adherence Scale. (MGLS) is a 4-item, generic self-reported, medication-taking behavior scale, validated for hypertension. Scores are correlated with BP control in patients with hypertension; poor adherence associated with increased stroke and transient ischemic attack (TIA) risk	Month 6 to Month 12
Other	Subject satisfaction with care results - Research Participant Perception Survey (RPPS) that was developed by Wake Forest University School of Medicine	Subject satisfaction with care results - Research Participant Perception Survey (RPPS) that was developed by Wake Forest University School of Medicine	Month 12
Other	Change in blood pressures following treatment	Change in blood pressures	Month 3 to Month 12
Other	Change in Cognitive function scores as assessed by the Montreal Cognitive Assessment (MoCA) scores	Change in Cognitive function scores as assessed by the Montreal Cognitive Assessment (MoCA) score - The MoCA is a well-validated tool consisting of 30 items that screens for mild cognitive impairment, is more sensitive to changes than the Mini-Mental State Exam (MMSE) due to inclusion of more complex executive function items, and can be feasibly administered in stroke populations. Each of the domains (Visuospatial/Executive, Naming, Memory, Attention, Language, Abstraction, Delayed Recall, and Orientation) are scored separately and the scores are summed to obtain a total score that falls between 0 and 30. A score above 26 is considered normal. Change in MoCA scores from baseline to 12 months post-stroke will be assessed.	Baseline to Month 12
Other	Change in (PROMIS) Patient-Reported Outcomes Measurement Information System Scores	The PROMIS-10 is a series of 10 questions that assess physical function; higher scores indicate higher physical function.	Baseline to Month 12
Other	Change in Modified Rankin Scale (mRS) Scores	The most widely-used global disability scale covering the range of functional outcomes that is intuitive for patients and clinicians, has excellent validity and correlates with other patient-centered outcome scales. A single point change is clinically relevant. The mRS is a 5-question scale, with final scoring ranging from 0-5. Participants who are known to be deceased are assigned a score of 6, and deaths will be ascertained from the National Death Index.	Baseline to Month 12
Primary	Intensive Tailored Telehealth Management (ITTM) versus Intensive Clinic Management (ICM) on achieving target Systolic Blood Pressure (SBP <130 mmHg)	The average of the second and third of 3 successive measures by the research coordinator according to standard protocols at baseline (Study Visit 1) and 6 months (Study Visit 3).	baseline
Primary	Intensive Tailored Telehealth Management (ITTM) versus Intensive Clinic Management (ICM) on achieving target Systolic Blood Pressure (SBP <130 mmHg) 6-months post-stroke.	The average of the second and third of 3 successive measures by the research coordinator according to standard protocols at baseline (Study Visit 1) and 6 months (Study Visit 3).	Month 6
Secondary	Change in Systolic Blood Pressure (SBP) at from baseline to 6 months post-stroke	Change in Systolic Blood Pressure (SBP) measured in mm Hg - SBP will be calculated as the average of the second and third of 3 successive measures by the research coordinator according to standard protocols. The associated endpoint is the mean change in SBP at 6 months among randomized participants.	Baseline to Month 6
Secondary	Number of major adverse cardiovascular events (MACE)	Number of major adverse cardiovascular events (MACE) - death or hospitalization from myocardial infarction, coronary heart disease, or stroke)	Month 12
Secondary	Number of patient activations for Blood Pressure (BP) management	Number of patient activations for Blood Pressure (BP) management - Defined as the PAM Score at baseline (Visit 1) subtracted from the PAM Score at 6 months (Visit 3). The PAM is a validated 13-item patient-reported outcome measure (PROM) that measures skills and confidence to self-manage chronic disease. Response options for the 13 items are disagree strongly, disagree, agree, agree strongly with an interval-level scale from 0 to 100. To obtain the total PAM score, a propriety scoring algorithm will be used, with higher PAM scores indicating higher patient activation. Change in PAM will be analyzed as a continuous variable.	Month 6