Stroke and Anxiety Reduction

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013982
• Other study ID #: 23-00759
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Bibi Sangster
• Phone: 212-263-7744
• Email: Bibi.Sangster[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Behavioral:
• Anxiety Reduction Bundle
The Anxiety Reduction Bundle intervention comprises the following resources: Stroke Support Group Anxiety Reduction Sheet Understanding Anxiety Disorder sheet Your body's response to anxiety sheet Relaxation Tip sheet Breathing Tip sheet and video A sigh of Relief video

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in GAD-7 Score from Baseline to 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.	Baseline, Month 3