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New Model of Stroke Education

Primary Purpose

Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Stroke Education
Verbal Stroke Education
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

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

Inclusion Criteria: Male or female ≥18 years of age at time of stroke. Documentation of a stroke diagnosis as evidenced by one or more clinical features consistent with deficits in physical mobility, mild deficits in language Exclusion Criteria: Documented history of stroke Documented cognitive deficits Individuals <18 years of age Individuals who are unable to provide consent Those who are pregnant will be excluded from this sample (pregnancy tests are typically completed on admission, for applicable individuals).

Sites / Locations

  • YNHH Rehabilitation & Wellness Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Written Stroke Education

Verbal Stroke Education

Arm Description

Participants in this arm will be given the current written standard of care for stroke education. Assessments will be completed during the participants inpatient stay.

Participants in this arm will be given the experimental verbal stroke education. Assessments will be completed during the participants inpatient stay.

Outcomes

Primary Outcome Measures

Stroke Knowledge Test (SKT)
SKT is a 20 question assessment to determine if written or verbal delivery of post stroke education was more successful in educating participants. The assessment is scored as a percentage of correct questions out of a total of 20 questions. Higher scores indicate more educated on stroke.

Secondary Outcome Measures

Count of post stroke follow up visits attended
Electronic medical records will be reviewed at 1, 3, 6 and 12 months post discharge to evaluate if participants had post stroke follow up visits with their care providers (recorded as yes/no). This will demonstrate which method is more likely to support patients in gathering information that is needed to manage their chronic conditions, maintaining compliance and decrease their chance of stroke recurrence.
Count of post stroke blood pressure readings above 130/80 mmHG systolic
Electronic medical records will be reviewed at 1, 3, 6 and 12 months post discharge to monitor how many post stroke blood pressure readings are above 130/80 mmHG systolic.This will demonstrate which method is more likely to support patients in gathering information that is needed to manage their chronic conditions, maintaining compliance and decrease their chance of stroke recurrence.
Medical compliance measured by count of prescriptions filled
Electronic medical records will be reviewed at 1, 3, 6 and 12 months post discharge to count the number of prescriptions filled that were ordered by the provider. Medical compliance will be assessed by the number of prescriptions filled. This will demonstrate which method is more likely to support patients in gathering information that is needed to manage their chronic conditions, maintaining compliance and decrease their chance of stroke recurrence.

Full Information

First Posted
November 4, 2022
Last Updated
September 15, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT05614882
Brief Title
New Model of Stroke Education
Official Title
New Model of Stroke Education
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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

5. Study Description

Brief Summary
The main goal of this study is to reorganize how stroke educational materials are given to patients from written delivery of information to using verbal delivery of information. Another goal is to compare post stroke behavior and medication compliance in participants receiving the new verbal model of stroke education vs. those receiving the current written stroke education. The main question[s] it aims to answer are: Does the current delivery of stroke education provide the necessary knowledge base for patients who have suffered a stroke as measured by a stroke questionnaire? Does verbal education provide better understanding for patients post-stroke? Are patients more likely to be compliant with medications and followup visits with their medical team after receiving verbal education? Participants will receive a health literacy assessment and based on their scores will be categorized into a high health literacy (HHL) or low health literacy group (LHL). Individuals in both literacy groups will be randomized into receiving verbal or written stroke education. All participants will be tested with the stroke knowledge assessment to measure learning after education. Researchers will compare written to verbal education to see if verbal results in more stroke education and compliance.
Detailed Description
The primary objective of this study is to restructure the current model of stroke education using verbal delivery of information that is accessible and understood by individuals of different cultural backgrounds and various literacy levels. Participants in this study will be provided with a new model of stroke education through verbal communication to educate them on factors related to stroke using vocabulary that is more familiar and understood by individuals with lower literacy levels. The current delivery of stroke information is carried out through a model that involves mainly written communication. Data will be collected to better understand the efficacy of the current written model of stroke education compared to the new verbal education and determine which of the two methods of delivering information is more compatible with the literacy levels of the community served by Yale New Haven Hospital. The second part of the study, participants' electronic medical record (EMR) will be reviewed at 1, 3, 6 and 12 months post stroke to evaluate the attendance post stroke follow up visits, post stroke blood pressure readings and overall medication compliance. Participants in this study will be based from a convenience sample from the Rehabilitation and Wellness Center in Milford, Connecticut. Participants will be admitted post-stroke after being diagnosed with stroke of mild to moderate severity. All the participants will receive a health literacy assessment and based on their scores will be categorized into a high health literacy (HHL) or low health literacy group (LHL) prior to randomization. Assessments will be completed during the participants inpatient stay. A run in pilot study of 20 anticipated participants will be carried out prior to the larger study. The larger study was registered in anticipation of NIH funding.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals in this study will be based from a convenience sample from the Rehabilitation and Wellness Center in Milford, Connecticut. Participants will be admitted post-stroke after being diagnosed with stroke of mild to moderate severity. Individuals will be over 18 years of age with no history of prior stroke who are able to read basic information, having no more than a mild aphasia with intact language comprehension skills who speak English or Spanish (assessment materials are available in these two languages). All the participants will receive a health literacy assessment and based on their scores will be categorized into a high health literacy (HHL) or low health literacy group (LHL) prior to randomization. Anticipated enrollment of 20 for pilot and 200 for larger study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Written Stroke Education
Arm Type
Active Comparator
Arm Description
Participants in this arm will be given the current written standard of care for stroke education. Assessments will be completed during the participants inpatient stay.
Arm Title
Verbal Stroke Education
Arm Type
Experimental
Arm Description
Participants in this arm will be given the experimental verbal stroke education. Assessments will be completed during the participants inpatient stay.
Intervention Type
Behavioral
Intervention Name(s)
Written Stroke Education
Intervention Description
The written education will be provided in the stroke folder currently in use by the Yale New Haven Health system. This written information is presented in a stroke folder and includes how to respond to the signs of stroke, dialing 9-1-1, following up with a health care provider after hospitalization due to a stroke and the importance of medication management as well as stroke risk factors, healthy eating habits, exercise habits, common changes following a stroke, stroke recurrence and stroke types. After being given two days to review the materials, patients will be asked to complete the stroke knowledge test (SKT). All participants will receive a health literacy assessment and based on their scores will be categorized into a high health literacy (HHL) or low health literacy group (LHL) prior to randomization.
Intervention Type
Behavioral
Intervention Name(s)
Verbal Stroke Education
Intervention Description
Participants in the verbal education group will be provided with education over two days from therapists including occupational therapy, physical therapy, speech therapy as well as a physician or nurse. The disciplines will present general stroke information including causes, risk factors, prevention, nutrition and exercise recommendations, importance of managing chronic conditions and the significance of medication compliance. After the verbal education topics are presented, the participants will be tested with the stroke knowledge test (SKT) to measure learning. All the participants will receive a health literacy assessment and based on their scores will be categorized into a high health literacy (HHL) or low health literacy group (LHL) prior to randomization.
Primary Outcome Measure Information:
Title
Stroke Knowledge Test (SKT)
Description
SKT is a 20 question assessment to determine if written or verbal delivery of post stroke education was more successful in educating participants. The assessment is scored as a percentage of correct questions out of a total of 20 questions. Higher scores indicate more educated on stroke.
Time Frame
1 day post intervention
Secondary Outcome Measure Information:
Title
Count of post stroke follow up visits attended
Description
Electronic medical records will be reviewed at 1, 3, 6 and 12 months post discharge to evaluate if participants had post stroke follow up visits with their care providers (recorded as yes/no). This will demonstrate which method is more likely to support patients in gathering information that is needed to manage their chronic conditions, maintaining compliance and decrease their chance of stroke recurrence.
Time Frame
Month 1 up to Month 12 post discharge
Title
Count of post stroke blood pressure readings above 130/80 mmHG systolic
Description
Electronic medical records will be reviewed at 1, 3, 6 and 12 months post discharge to monitor how many post stroke blood pressure readings are above 130/80 mmHG systolic.This will demonstrate which method is more likely to support patients in gathering information that is needed to manage their chronic conditions, maintaining compliance and decrease their chance of stroke recurrence.
Time Frame
Month 1 up to Month 12 post discharge
Title
Medical compliance measured by count of prescriptions filled
Description
Electronic medical records will be reviewed at 1, 3, 6 and 12 months post discharge to count the number of prescriptions filled that were ordered by the provider. Medical compliance will be assessed by the number of prescriptions filled. This will demonstrate which method is more likely to support patients in gathering information that is needed to manage their chronic conditions, maintaining compliance and decrease their chance of stroke recurrence.
Time Frame
Month 1 up to Month 12 post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥18 years of age at time of stroke. Documentation of a stroke diagnosis as evidenced by one or more clinical features consistent with deficits in physical mobility, mild deficits in language Exclusion Criteria: Documented history of stroke Documented cognitive deficits Individuals <18 years of age Individuals who are unable to provide consent Those who are pregnant will be excluded from this sample (pregnancy tests are typically completed on admission, for applicable individuals).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Necolle Morgado-Vega, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
YNHH Rehabilitation & Wellness Center
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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New Model of Stroke Education

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