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Stroke and Anxiety Reduction

Primary Purpose

Acute Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anxiety Reduction Bundle
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Stroke

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients discharged following acute care stroke

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2023
Last Updated
August 23, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT06013982
Brief Title
Stroke and Anxiety Reduction
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients discharged following acute care stroke
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Anxiety Reduction Bundle
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in GAD-7 Score from Baseline to Month 3
Description
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.
Time Frame
Baseline, Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bibi Sangster
Phone
212-263-7744
Email
Bibi.Sangster@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Zavotsky
Phone
212-263-2055
Email
Kathleen.zavotsky@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bibi Sangster
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This is a pilot study and the data will need to be evaluated before it is shared.

Learn more about this trial

Stroke and Anxiety Reduction

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