NCT01071408

Brief Summary

The purpose of this study is to determine whether an outpatient program can reduce the risk of recurrent stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

2.2 years

First QC Date

February 12, 2010

Last Update Submit

May 14, 2012

Conditions

Keywords

chronic care modelstroke preventionhealth services research

Outcome Measures

Primary Outcomes (1)

  • Blood pressure control

    baseline, 3 months, 7 months

Secondary Outcomes (4)

  • control of other stroke risk factors including lipids, smoking, and exercise

    baseline, 3 months, 7 months

  • patient perceptions of care quality

    baseline, 3 months, 7 months

  • medication adherence

    baseline, 3 months, 7 months

  • Stroke knowledge

    baseline, 3 months, 7 months

Study Arms (2)

Stroke Prevention Program + Usual Care

EXPERIMENTAL

Stroke Prevention Care Program + Usual Care. The Stroke prevention care program is in addition, not a substitute for usual care. Persons randomized to this arm are eligible to all care, including care by stroke specialists, while enrolled in the intervention.

Other: Stroke prevention care program

Usual care

NO INTERVENTION

Interventions

Stroke prevention care program consists of group clinics, telephone coordination of care, and tracking of care through registries in the first 7 months after stroke or TIA presentation. A nurse practitioner will follow algorithms to adjust medications and to motivate patients to improve lifestyle habits.

Also known as: group clinics, chronic care model, secondary stroke prevention program, nurse practitioner, medication algorithms
Stroke Prevention Program + Usual Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ischemic stroke within the past 30 days
  • transient ischemic attack within the past 30 days
  • person receiving care at VA Long Beach Healthcare System

You may not qualify if:

  • unable to understand informed consent
  • already enrolled in another research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Long Beach Health Care System

Long Beach, California, 90822, United States

Location

MeSH Terms

Conditions

Ischemic StrokeIschemic Attack, Transient

Interventions

Chronic Care ModelNurse Practitioners

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

Delivery of Health Care, IntegratedDelivery of Health CarePatient Care ManagementHealth Services AdministrationNursesHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Eric M Cheng, MD, MS

    VA Long Beach Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

February 12, 2010

First Posted

February 19, 2010

Study Start

March 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations