New Model of Stroke Education

NCT05614882 | Withdrawn DMC

• 1 other identifier: 2000033911
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day post intervention

Secondary Outcomes (3)

• Count of post stroke follow up visits attended

  Month 1 up to Month 12 post discharge

• Count of post stroke blood pressure readings above 130/80 mmHG systolic

  Month 1 up to Month 12 post discharge

• Medical compliance measured by count of prescriptions filled

  Month 1 up to Month 12 post discharge

Study Arms (2)

Written Stroke Education

ACTIVE COMPARATOR

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.

Behavioral: Written Stroke Education

Verbal Stroke Education

EXPERIMENTAL

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

Behavioral: Verbal Stroke Education

Interventions

Written Stroke Education BEHAVIORAL

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.

Written Stroke Education

Verbal Stroke Education BEHAVIORAL

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.

Verbal Stroke Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

YNHH Rehabilitation & Wellness Center

Milford, Connecticut, 06460, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Necolle Morgado-Vega, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: October 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)