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HomeVENT Decision Support Tool for Respiratory Insufficiency in Children (HomeVENT Trial)

N/A
Recruiting
Led By Renee Boss, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months, 12 months
Awards & highlights

HomeVENT Trial Summary

This trial tests a support process to help families and clinicians make decisions about home ventilation for a child. Families and physicians will be surveyed at different points to assess how the process impacts decision-making.

Who is the study for?
This trial is for parents or primary caregivers over 18, who speak English or Spanish and are making decisions about home ventilation for their child. It's also for physicians involved in these decisions. Participants must be willing to follow the study procedures and be available throughout the study.Check my eligibility
What is being tested?
The HomeVENT decision support tool is being tested to see if it helps families make better-informed choices regarding chronic home ventilation for a child. Families will either receive usual care or use the intervention with guidance, followed by interviews and surveys.See study design
What are the potential side effects?
Since this trial involves a decision-making support process rather than medication, there are no direct medical side effects. However, participants may experience emotional or psychological impacts from discussing sensitive health decisions.

HomeVENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale.
Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale
Shared Decision Making among parents making decisions about home ventilation as assessed by the Consumer Assessment of Healthcare Providers and Systems (CAHPS-SDM) survey
+1 more
Secondary outcome measures
Change in Impact of decision about home on daily life of child/ family as assessed by a qualitative interview
Change in Quality of Life expected vs. actual, among parents who faced choice about home ventilation as assessed by the Pediatric Quality of Life Family Impact Module (PEDSQL) scale
Change in decision making regret among parents who chose for or against home ventilation as assessed by the Decision Regret Scale

HomeVENT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Will review a web-based decision-making tool with families and simultaneously interview family regarding website topics. Will interview families and clinicians at 1 month, and families again at 6 and 12 months
Group II: Usual CareActive Control1 Intervention
No alteration in care. Will interview families and clinicians at 1 month, and families again at 6 and 12 months

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,266 Previous Clinical Trials
14,836,897 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,197 Total Patients Enrolled
Renee Boss, MDPrincipal InvestigatorJohns Hopkins School of Medicine

Frequently Asked Questions

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

Is this research endeavor still open to enrollment?

"As indicated on clinicaltrials.gov, recruitment for this scientific trial concluded as of October 19th 2023; it had been posted since November 1st the same year. Nonetheless, 226 other trials are currently in search of patients to participate in their studies."

Answered by AI
~400 spots leftby Dec 2029