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Clinical Trials/NCT06013982
NCT06013982
Completed
Not Applicable

Impact of a Structured Anxiety Reduction Program on Anxiety in Patients Who Are Discharged to Home Following an Acute Stroke in an Academic Medical Center

NYU Langone Health1 site in 1 country34 target enrollmentAugust 22, 2023
ConditionsAcute Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Stroke
Sponsor
NYU Langone Health
Enrollment
34
Locations
1
Primary Endpoint
Change in GAD-7 Score from Baseline to Month 3
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this pilot study is to explore the impact that a structured anxiety reduction intervention program has on patients being discharged to home following an acute stroke in an academic medical center. Eligible participants will be screened and recruited by the research team through daily rounds. After completing the informed consent process, the research team will pull demographic information from the electronic health record (EHR) and REDCAP that includes ethnicity and support system. Participants will complete the Anxiety Screen Questionnaire (GAD-7 ANXIETY SURVEY) and will be provided with information regarding stroke support groups available with additional NYU Langone Health and the American Heart Association internet-based information regarding anxiety reduction (NYU Langone Health Anxiety Reduction Bundle). The participants will be encouraged to attend a stroke support group for 3 months and utilize the NYU Langone Health Anxiety Reduction Bundle provided. At the completion of the intervention (3 months), participants will be provided with the GAD-7 ANXIETY SURVEY again and a survey that includes open-ended questions and a program evaluation by email. Analysis will occur after final data is collected.

Registry
clinicaltrials.gov
Start Date
August 22, 2023
End Date
January 23, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Be diagnosed with an acute stroke
  • Able to speak, read and write in English
  • Not cognitively impaired, as per standard of care documentation in the EHR regarding mental status.
  • Discharged to home
  • Internet access including email
  • Willingness to participate in an anxiety reduction program
  • Length of hospital stay less than 5 days from the initial presentation of stroke symptoms
  • Must be medically stable

Exclusion Criteria

  • Not diagnosed with an acute stroke
  • Unable to speak, read and write in English as this intervention is not available in other languages and at this time, funding is not available in order to have the resources provided translated or to have translation services available for these participants.
  • Not discharged to home
  • No internet access including email
  • Unwilling or unable to participate in an anxiety reduction program
  • Cognitively impaired
  • Length of hospital stay greater than 6 days from the initial presentation of stroke symptoms
  • Not medically stable

Outcomes

Primary Outcomes

Change in GAD-7 Score from Baseline to Month 3

Time Frame: Baseline, Month 3

The GAD-7 Anxiety Questionnaire involves 7 items assessing how often participants have felt bothered by anxiety-related problems over the past two weeks. Each item is rated on a Likert scale from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0-21; where 0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 = severe anxiety.

Study Sites (1)

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