Clinical trial NCT03861494: REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers (RESPPECT Trial)
Official title: REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: Washington Regional Medical Center
Sponsor class: OTHER
First posted: 2019-03-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This a single blind randomized control study comparing standard of care for nursing hospital discharge education versus same with an additional experimental enhanced educational intervention. It is planned that 300 patients will be enrolled in the study. There are two initial groups: the enhanced stroke education vs usual stroke education.

Detailed description: This a single blind randomized control study comparing standard of care for nursing hospital discharge education versus same with an additional experimental enhanced educational intervention. It is planned that 300 patients will be enrolled in the study. There are two initial groups: the enhanced stroke education vs usual stroke education. Patients who meet inclusion and not exclusion criteria and provide signed informed consent will be randomized to one of the two groups. Assignments will be made based on the order of entry into the stroke study database where every other patient entered will be assigned to the treatment group. If the patient's caregiver is the primary person responsible for administration of medication, determination of meals and activity, the caregiver may be enrolled instead of or in addition to the patient. This will be determined by preference of the patient and caregiver after discussion of their usual practice. A Neuroscience trained Registered Nurse is a nurse who has received specialized education from the organization regarding care of patients with stroke and other neurologic illnesses. The Neuroscience trained Registered Nurse will provide all patients with basic stroke and risk factor information, educational materials and follow-up. The usual care group of patients will receive education provided by the Neuroscience trained Registered Nurse who provides care for the patient daily. Education will be provided on an ongoing basis throughout the hospital stay with additional focused education provided at the time of discharge (within 24 hours of hospital discharge). The education will include written and verbal information. Educational content focuses on a variety of topics of stroke prevention, detection and management. The enhanced stroke education group will receive the same usual care for patient education given by the Neuroscience trained Registered Nurse. The enhanced stroke education patient will receive a one -time enhanced specific goal-directed educational experience given by a specifically trained Stroke Coordinator on the day of discharge. The enhanced education is tailored to the unique risk factors of the patient and key concepts for stroke prevention, detection and management The patient will be given goals specific to their personal risk factors. Emphasis on specific goals for lifestyle change are emphasized. Verbal feedback of key concepts is encouraged.

Eligibility criteria: Inclusion Criteria:

* patients hospitalized with primary diagnosis of acute or subacute ischemic cerebral infarction
* 18 years of age or older
* English speaking
* admitted to hospital Sunday through Thursday
* patient or responsible primary caregiver able to understand and provide informed consent
* prognosis for survival greater than 6 months
* one or more vascular risk factors (HTN, DLP, current smoker, DM, obesity)
* live in NWA area (Benton, Boone, Carroll, Madison, and Washington counties),
* have a working phone.

Exclusion Criteria:

* admitted with transient ischemic attack
* admitted with an intracerebral hemorrhage
* experience an in-hospital ischemic cerebral infarction
* hospital to hospital transfer patients
* nursing home as primary residence before or after discharge
* hospice
* inability to comply with post discharge follow up

Primary outcomes:
measure: Change in score of Stroke Knowledge Questionnaire
timeFrame: 30 days
measure: Change in hospital readmission rate
timeFrame: 30 days
measure: Change in score of Stroke Knowledge Questionnaire
timeFrame: 180 days
measure: Change in hospital readmission rate
timeFrame: 180 days
Secondary outcomes:
measure: Change in Brief Health Literacy Screen
timeFrame: 30 days
measure: Change in systolic blood pressure
timeFrame: 30 days
measure: Change in Modified Rankin Score
timeFrame: 30 days
measure: Change in Barthel Index
timeFrame: 30 days
measure: Change in Brief Health Literacy Screen
timeFrame: 180 days
measure: Change in Modified Rankin Score
timeFrame: 180 days
measure: Change in Barthel Index
timeFrame: 180 days
measure: Change in systolic blood pressure
timeFrame: 180 days
measure: Change in Low Density Lipoprotein cholesterol
timeFrame: 150 -180 days
measure: Change in Glycated Hemoglobin
timeFrame: 150-180 days
measure: Change in Body Mass Index
timeFrame: 180 days
measure: Change in compliance with antithrombotic, cholesterol, antihypertensive, and diabetic medications.
timeFrame: 180 days
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Arkansas
Study officials:
affiliation: Washington Regional Medical Center
name: Margaret Tremwel, MD
role: PRINCIPAL_INVESTIGATOR
References: