Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

Hypertension Secondary Clinical Trial

— TEAMS-BP  

Official title:

Telehealth-Enhanced Assessment and Management After Stroke-Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05539443
• Other study ID #: IRB00085596
• Secondary ID: PLACER-02020C3-2
• Status: Completed
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: July 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TEAMS-BP is a multicenter, participant-randomized controlled trial designed to compare the effectiveness of Intensive Tailored Telehealth Monitoring (ITTM) versus Intensive Clinic Management (ICM) on Blood Pressure (BP) control and patient activation for BP management following stroke

Description:

The Feasibility phase will allow for a period in which to pilot implementation and evaluation of all systems for data acquisition, clinical management, and collection of 3-month outcomes. The study uses a parallel, 2-arm design with 1-to-1 randomization to treatment group. Randomization will be performed at the participant level, stratified by center, age (18-74, 75+), and race (Black/African American, non-Black/African American).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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

• SBP>130 at the post-acute clinic visit (within 21 days of discharge) & at Study Visit 1 (within 31 days of discharge)

• Able to read and understand English or Spanish

• Have access to a functioning smartphone or tablet with broadband access (required for the intervention)

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

• 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

• 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

• Hypertension
• Hypertension Secondary

Intervention

Behavioral:
• Intensive Clinic Management (ICM)
An in-person clinic management based on the intervention tested among stroke patients in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial
• Intensive tailored telehealth management (ITTM)
A remote-monitoring blood pressure (BP) management strategy incorporating individualized lifestyle coaching and care planning based on the HyperLink telehealth management trial

Locations

Country	Name	City	State
United States	Atrium Health Wake Forest Baptist	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
Primary	Proportion of participants with 3-month SBP control		3 months
Secondary	Mean change in systolic blood pressure (SBP) at 3 months	Defined as the SBP at baseline (Visit 1) subtracted from the SBP at 3 months (Visit 2).	Baseline, 3 month
Secondary	Mean change in Partners in Health Scale (PIH) score at 3 months	Each of the 11 items on the PIH have eight response options ranging from (0) very good to (8) very poor. To calculate the total PIH score, the raw score is summed and transformed to a range [0,100], with lower PIH scores indicating higher patient activation.	Baseline, 3 month
Secondary	Proportion of participants eligible among those screened		3 Month
Secondary	Proportion of participants providing written informed consent among those eligible		Baseline
Secondary	Proportion of participants attending both visits among those who are randomized in the study		3 months
Secondary	Systolic Blood Pressure Mean Value		3 months
Secondary	Proportion of respondents with top score in overall experience on the Research Participant Perception Survey (RPPS)	The overall experience (Overall Rating) is rated on a 10-point scale from 0 (Worst) to 10 (Best). The top score is for overall score includes all participants that responded 9 or 10.	3 months
Secondary	Proportion of participants billed	Proportion of participants for which coaching or remote physiologic monitoring services were billed (at any point during the study) using Current Procedural Terminology (CPT) billing codes.	3 months