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Stroke and Anxiety Reduction

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06013982
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
5
Anticipated Duration (Months)
9.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Anxiety Reduction Bundle
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients discharged following acute care stroke

Participation will last 3 months from enrollment. Demographic data will be retrieved from the electronic health record and the Generalized Anxiety Disorder-7 (GAD-7) Anxiety Questionnaire will be administered at baseline. Participants will repeat the GAD-7 in 3 months and an additional qualitative survey on their experience including an evaluation of the structured anxiety reduction program.

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

Outcome Measures

Primary Outcome Measures

  1. Change in GAD-7 Score from Baseline to Month 3 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Bibi Sangster, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT06013982
Other Study ID Numbers:
  • 23-00759
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Aug 28, 2023