ENGAGE for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University, Saint Louis, MO
Stroke
ENGAGE - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a community-based intervention may help improve community participation after stroke.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether ENGAGE will improve 3 primary outcomes and 1 secondary outcome in patients with Stroke. Measurement will happen over the course of week 7.

Week 7
Change in PROMIS Ability to Participate in Social Roles from week 1 to week 7
week 7
Acceptability, indicated by score 24 or higher out of 32 on the Client Satisfaction Questionnaire
Adverse Events, defined as reported injuries or injurious falls
Fidelity, indicated by score of 18 or higher out of 20 on the ENGAGE Fidelity Checklist

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

ENGAGE
1 of 1
Experimental Treatment

This trial requires 32 total participants across 1 different treatment group

This trial involves a single treatment. ENGAGE 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.

ENGAGE
Behavioral
The intervention blends social learning, guided discovery, and skill training to promote community participation after stroke. The intervention is delivered in a group format and comprises group learning activities and individual action planning activities that address barriers to community participation after stroke.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ENGAGE
2013
Completed Phase 2
~180

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 1 vs week 7
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 1 vs week 7 for reporting.

Who is running the study

Principal Investigator
E. R. S. O.
Prof. Elizabeth R. Skidmore, OTR/L, PhD
University of Pittsburgh

Closest Location

Washington University - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People who have low incomes and are uninsured or underinsured are at a high risk for going without needed health care. show original
ages 18 and older
A stroke that lasts for three months or longer is called chronic. show original
community-dwelling
People who have had a mild to moderate stroke and have a score of NIHSS less than or equal to 16 have some degree of stroke-related disability. show original
The text is about how people are restricted in their community participation after having a stroke show original
able to provide written informed consent

Patient Q&A Section

What are the signs of stroke?

"The signs of stroke include focal neurological changes such as weakness, aphasia, paralysis, or numbness of a limb. When a person with stroke is admitted to hospital, it is advisable for the patient to be moved from their usual position into a sitting or supine posture, as these positions can reduce their pressure on their brain. In a situation where a stroke is suspected, a patient must be monitored throughout their stay in hospital to identify whether an acute stroke is occurring, and with time, whether the stroke progresses or recurs in any other part of the body." - Anonymous Online Contributor

Unverified Answer

What causes stroke?

"There are several risk factors for stroke including diabetes, high blood pressure, cholesterol embolisms, atrial fibrillation and a history of stroke. These are often more common in men than in women and generally occur concurrently.\n" - Anonymous Online Contributor

Unverified Answer

What are common treatments for stroke?

"A small number of drugs are administered to patients with stroke, but most are used in a small number of cases. As yet no drugs have been approved for use against all forms of stroke." - Anonymous Online Contributor

Unverified Answer

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

"There were 57,100 strokes in 1995. In spite of an average annual rate of stroke of 20 per 100,000, this rate was slightly higher than the average for the United Kingdom and France. The highest incidence rates were in the Northeast and West. The highest stroke mortality rates occurred in the South and in the Midwest." - Anonymous Online Contributor

Unverified Answer

What is stroke?

"Stroke, which typically occurs as a result of a blood clot, is damage to the brain that causes temporary problems in body functions. Symptoms can be related to the part of the brain that is damaged. The symptoms can include loss of muscle control, weakness on the opposite side of the body, blindness, slurred speech, and vomiting." - Anonymous Online Contributor

Unverified Answer

Can stroke be cured?

"In stroke, there are 3 types of recurrent stroke: subacute phase, remission phase, and recurrences of acute phase. Most people do not regain ability to speak in full and do not have full restoration of activities of daily living. Functional remission seems to be achievable, especially in patients with ischemic stroke. At present, the current treatment is not satisfactory, and the rehabilitation should be provided in a more intensive manner." - Anonymous Online Contributor

Unverified Answer

Is engage typically used in combination with any other treatments?

"In conclusion, most patients used the same treatment regardless of their condition: antiplatelet agents or statins. Patients' choice of treatment seems related to individual characteristics. Furthermore, patients usually reported more adherence to treatment than clinicians." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving engage?

"We failed to find any clinical trial to demonstrate significant effect of engaging on stroke rehabilitation. We would advise against using engaging on stroke rehabilitation." - Anonymous Online Contributor

Unverified Answer

What does engage usually treat?

"There are several ways for people to engage to find remedies for stroke. One is to get medical help. Another is just to be a common-minded person and use one's own brains. The second is to go to a professional health provider with any questions and symptoms" - Anonymous Online Contributor

Unverified Answer

How does engage work?

"A significant difference was noted between engine types in the efficiency at the beginning and the end of the shift, but no difference related to the duration of the shift. It seems that the duration of the shift plays no role in the engage efficiency. In any case, the average energy efficiency decreased during the course of the shift." - Anonymous Online Contributor

Unverified Answer

What is engage?

"Effective rehabilitation programmes can be delivered, but key outcomes such as participation and self-efficacy are not being achieved in the overwhelming majority. Efforts to modify current paradigms of rehabilitation service delivery are now likely to have an impact on key outcomes. An opportunity is presented to develop and test interventions that can target both effectiveness and acceptability." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets stroke?

"Stroke of 45 years of age and more is frequent, despite the increase in the number of screened stroke patients and increase in the number of people diagnosed with stroke. This suggests that stroke remains a preventable disease. Stroke clinics are not used to see such a patient." - 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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