Clinical trial NCT05614882: New Model of Stroke Education
Official title: New Model of Stroke Education
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Stroke Knowledge Test (SKT)
timeFrame: 1 day post intervention
Secondary outcomes:
measure: Count of post stroke follow up visits attended
timeFrame: Month 1 up to Month 12 post discharge
measure: Count of post stroke blood pressure readings above 130/80 mmHG systolic
timeFrame: Month 1 up to Month 12 post discharge
measure: Medical compliance measured by count of prescriptions filled
timeFrame: Month 1 up to Month 12 post discharge
Other outcomes:
Locations:
city: Milford
country: United States
facility: YNHH Rehabilitation & Wellness Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Necolle Morgado-Vega, MD
role: PRINCIPAL_INVESTIGATOR
References: