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Digital Decision Aid + Communication Tool for Hemorrhagic Stroke

N/A
Waitlist Available
Led By Susanne Muehlschlegel, MD, MPH
Research Sponsored by University of Massachusetts, Worcester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient has SABI; defined as either traumatic brain injury, spontaneous primary intracerebral hemorrhage (not due to tumor or vascular malformation), or hemispheric acute ischemic stroke
Patient is "critically ill" defined as either intubated on a mechanical ventilator, or unable to swallow without a feeding tube (even if not intubated/ventilated)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three-months post sabi
Awards & highlights
No Placebo-Only Group

Study Summary

This trial aims to create a web-based tool to help family members of patients with SABI make decisions in ICUs.

Eligible Conditions
  • Traumatic Brain Injury
  • Stroke
  • Hemorrhagic Stroke

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a severe brain injury, bleeding in the brain not caused by a tumor or blood vessel problem, or a recent major stroke.
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You are very sick and need a machine to help you breathe, or you cannot swallow food without a tube.
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Your doctor thinks there is a high chance (at least 40%) that you could die or have long-term difficulty doing daily activities.
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You must be 18 years or older to participate, and there is no maximum age limit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months post sabi
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months post sabi for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of enrolling surrogates in a stepped-wedge (before/after) clinical trial in a neurocritical care setting
Feasibility of retaining surrogates in a neurocritical care setting
Feasibility of tool use by surrogate decision-makers
Secondary outcome measures
Fidelity to intervention protocol
Participants' ratings of perceived effectiveness of the tool in preparing them for decision-making (Intervention surrogates only)
Participants' ratings of usability of the tool (Intervention surrogates only)
Other outcome measures
Caregiver Burden
Decision Regret
Functional status
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Web-based Decision Aid + Communication (DA+C) toolExperimental Treatment1 Intervention
Surrogate(s) will read/click through the DA+C tool prior to the clinician-family meeting and complete the integrated worksheet. Surrogate(s) will have unlimited access to the DA+C tool and may return to the tool and edit the worksheet at any time.
Group II: Usual CareActive Control1 Intervention
No decision aid

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,226 Previous Clinical Trials
14,811,769 Total Patients Enrolled
University of Massachusetts, WorcesterLead Sponsor
336 Previous Clinical Trials
760,880 Total Patients Enrolled
Worcester Polytechnic InstituteOTHER
15 Previous Clinical Trials
1,921 Total Patients Enrolled

Media Library

Web-based Decision Aid + Communication (DA+C) tool Clinical Trial Eligibility Overview. Trial Name: NCT05671874 — N/A
Traumatic Brain Injury Clinical Trial 2023: Web-based Decision Aid + Communication (DA+C) tool Highlights & Side Effects. Trial Name: NCT05671874 — N/A
Web-based Decision Aid + Communication (DA+C) tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05671874 — N/A
Traumatic Brain Injury Research Study Groups: Web-based Decision Aid + Communication (DA+C) tool, Usual Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open registrations for this medical experiment?

"Per clinicaltrials.gov, this particular trial is not presently recruiting patients - though it originally opened on the 16th of January in 2023 and was last updated on the 3rd of Janurary that same year. However, there are over 1,300 other trials actively searching for participants right now."

Answered by AI
~30 spots leftby Jun 2025