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Coordinated, Collaborative, Comprehensive, Family-based, Integrated, Technology-enabled Stroke Care

NCT04000971 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1196

Last updated 2026-05-15

Study results available
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Summary

Stroke is the 5th leading cause of death and the leading cause of adult disability in the United States (US). Stroke is a complex disease with multiple interacting risk factors (including genetic, high blood pressure and cholesterol, and lifestyle factors like smoking, diet, and exercise) that lead to initial and recurrent stroke. Up to 90% of stroke survivors have some functional deficit that impacts both physical and mental health.

Conditions

  • Stroke
  • Stroke, Ischemic
  • Stroke, Acute
  • Stroke Sequelae
  • Engagement, Patient
  • Stroke Hemorrhagic

Interventions

OTHER

Integrated Stroke Practice Unit

Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, and increase understanding and build positive behavior change for patients and caregivers. Primary and secondary outcomes will be assessed at 3, 6, and 12 months.

OTHER

Comprehensive or Primary Stroke Center

Primary and secondary outcomes will be assessed at 3, 6, and 12 months.

Sponsors & Collaborators

Principal Investigators

  • Kenneth Gaines, MD · Vanderbilt University Medical Center

  • Barry Jackson

  • George Howard, DrPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04000971 on ClinicalTrials.gov