Treatment for Hemorrhagic Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Covenant Health Fort Sanders Regional Medical Center, Knoxville, TN
Hemorrhagic Stroke+6 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new stroke care design can improve outcomes for people with stroke.

See full description

Eligible Conditions

  • Hemorrhagic Stroke
  • Patient Engagement
  • Stroke, Ischemic
  • Stroke, Acute
  • Stroke; Sequelae
  • Stroke

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 15 secondary outcomes in patients with Hemorrhagic Stroke. Measurement will happen over the course of 12 months post-stroke.

12 months post-stroke
Stroke Impact Scale (SIS 3.0)
Month 6
Modified Rankin Scale
Stroke Impact Scale 3.0
Month 12
Depression: Patient Health Questionnaire (PHQ-9)
Modified Caregiver Strain Index (mCSI)
Mortality
Recurrence
Rehospitalization
Stroke Risk Factors - Blood Pressure Control (BP)
Stroke Risk Factors - Blood Sugar (HgBA1c)
Stroke Risk Factors - Body Mass Index (BMI)
Stroke Risk Factors - Cholesterol (LDL)
Stroke Risk Factors - Diet
Stroke Risk Factors - Exercise
Stroke Risk Factors - Smoking Status/Cessation
Time at Home

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Integrated Stroke Practice Unit (ISPU)
1 of 2
Comprehensive or Primary Stroke Center (CSC/PSC)
1 of 2
Active Control

This trial requires 1800 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Integrated Stroke Practice Unit (ISPU)
Other
ISPU personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge. This will be supplemented by a more integrated model designed to increase coordination through team-based initiatives across the continuum of care for stroke - from acute and in-hospital care through 12 months post-discharge. Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, increase understanding, and build positive behavior change for patients and caregivers. Primary outcomes will be assessed by phone at 3, 6, 12, and 24 months; secondary outcomes will be assessed at 3, 6, and 12 months.
Comprehensive or Primary Stroke Center (CSC/PSC)
Other
CSC/PSC personnel will continue with care provided under the Joint Commission-certified CSC/PSC design, including a 30-day clinic visit post-discharge, follow-up clinic visits as recommended by their outpatient provider, and other clinic visits initiated by the patient when issues arise. Primary outcomes will be assessed by phone at 3, 6, 12, and 24 months; secondary outcomes will be assessed at 3, 6, and 12 months.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, and 12 months post-stroke
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3, 6, and 12 months post-stroke for reporting.

Who is running the study

Principal Investigator
K. G.
Prof. Kenneth Gaines, Professor, Neurology; Medical Director, Vanderbilt Teleneurology
Vanderbilt University Medical Center

Closest Location

Covenant Health Fort Sanders Regional Medical Center - Knoxville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hemorrhagic Stroke or one of the other 6 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
There are two different types of subjects when it comes to language- English speaking subjects and Spanish speaking subjects show original
The pre-morbid Rankin score was 0-1. show original
Patients who go to rehabilitation therapy inpatient care or other care facilities in the geographic area of recruitment are eligible, as long as they do not go to hospice care. show original
The patient has a clinical diagnosis of an acute stroke, and the brain imaging is compatible with either an intracerebral hemorrhage or an ischemic stroke. show original
The patient was admitted to the hospital within seven days of their initial stroke event. show original
A patient living within the geographical area recruited for a C3FIT site is considered to be living at discharge within that site. show original
Age 18+.
The patient was discharged from the hospital and is not going to hospice care. show original
Patients and their surrogates agree to take part in the study after discussing the risks and benefits of the study in an informed consent process. show original

Patient Q&A Section

What is stroke?

"Stroke refers to a focal impairment of brain function from a cerebral blood flow constraint that originates in the brain or is the result of an embolic event. Stroke is usually the result of a large vessel infarct, which are typically located on the right side of the body due to the heart being on the left. Strokes are often classified by either being ischaemic (due to occlusion of a blood vessel) or haemorrhagic (due to leakage from a blood vessel) and they cause serious disability. Stroke commonly affects the blood vessels supplying the brain causing the blood vessels to become narrowed and constricted. The arteries that supply the brain are called intracranial blood vessels." - Anonymous Online Contributor

Unverified Answer

Can stroke be cured?

"Stroke can be divided into reversible and nonreversible syndromes. Reversible stroke is amenable to treatment and complete neurologic recovery can occur. Patients who experience nonreversible strokes remain chronically impaired and can benefit from rehabilitation, which significantly improves the quality of life for most patients." - Anonymous Online Contributor

Unverified Answer

What are common treatments for stroke?

"The most commonly used treatment is surgery, with other treatments including medication, other medical care, physical therapy, and occupational therapy. The quality of research on which treatments are most effective is poor, and many treatments have not been scientifically studied adequately. Also, the quality of stroke data collection is poor." - Anonymous Online Contributor

Unverified Answer

What causes stroke?

"Genetic factors account for a significant proportion of the risk of stroke, and lifestyle factors are also important. Many stroke risk factors appear to have common genetic or environmental pathways. Risk factors that affect blood pressure and blood lipids show a stronger association with stroke than those of smoking or obesity." - Anonymous Online Contributor

Unverified Answer

What are the signs of stroke?

"The majority (95%) of people presenting to an acute stroke unit have some evidence of stroke. About half of these individuals (41%) have transient ischaemic attacks (TIAs) or acute transient focal cerebral ischaemic events (TFCIEs). Although there is substantial overlap between the signs and symptoms of stroke and the signs of TIAs and TFCIEs, these may serve as important clinical signposts highlighting TIA/stroke as a continuum of conditions with common risk factors. The presence of sensory loss, new motor and sensory deficits and speech and language disturbance are signs of stroke." - Anonymous Online Contributor

Unverified Answer

How many people get stroke a year in the United States?

"Approximately 430,700 Americans have a stroke each year, making up around 9% of all American adults. These strokes cause around 78,000 deaths each year and result in long-term disability for almost one-third of these patients." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with stroke?

"All of the measures related to life impact after stroke had significant correlations with the measure of quality of life. The patients' quality of life was significantly less the more they had to be bedridden. The degree of dependence and pain after stroke appeared to correlate with their quality of life." - Anonymous Online Contributor

Unverified Answer

Has treatment proven to be more effective than a placebo?

"For the treatment to be effective, it should produce a statistically significant difference from the baseline to the post-treatment group and it had to be higher in the treatment group compared to the control group and to the baseline. This should reflect a good improvement on the scale. Thus, to summarize these results, an improvement between 10% and 15% of the value at the end of 4 weeks was considered to be a significant difference. From a meta-analysis of 14 trials, we can conclude that stroke management and quality of life of patients in the two groups does not present a statistically significant difference on the 4-week period." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets stroke?

"The mean age at stroke incidence is 73 years old for all stroke subtypes and for both male and female stroke sufferers. This information is important for stroke education and should be reported to aid stroke prevention strategies." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"Most patients with a minor stroke seem to benefit from current treatments for strokes. Some patients' early stroke symptoms seem to resolve when they are treated with aspirin, and most patients seem satisfied with treatment. However, many patients are not monitored and a minority does not realize their strokes are unlikely to worsen. In light of these findings, it is imperative that healthcare providers ensure patients understand the steps needed for follow-up visits in the event of a relapse. Patients can also benefit from being informed of the risk of having a major stroke." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"The data we obtained were similar to those from other studies. In a previous study, this study was one of the largest cohorts to have been used in a systematic review to assess the treatment of vascular patients; as such it represents a 'gold standard' comparison." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving treatment?

"There is little evidence that intravenous thrombolysis improves neurological outcome in patients with acute stroke beyond that seen in this trial. While the benefit of intravenous thrombolysis is well established, treatment rates remain low in acute stroke, suggesting that increased public awareness of and improved access to acute stroke treatment may be more effective than further research on intravenous thrombolysis. We suggest that further studies with wider sample sizes of patients would be useful in confirming that intravenous thrombolysis is an effective treatment of acute stroke." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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