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HELPix Care Plan for Medical Complexity in Children
N/A
Recruiting
Led By Alexander F Glick, MD, MS
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The individual's child is ≤18 years old
The individual's child was discharged home or is expected be discharged home on ≥1 daily medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 4 (day 30-45)
Awards & highlights
Study Summary
This trial is testing an app designed to help parents of children with medical complexity care for their children and reduce the chance of bad outcomes after leaving the hospital.
Who is the study for?
This trial is for parents or legal guardians who are the primary caregivers of children with complex medical needs, such as chronic conditions in multiple body systems, reliance on technology like respiratory equipment, or serious progressive illnesses. The child must be under 18 years old and discharged home on medication. Caregivers must speak English or Spanish and be willing to participate fully in the study.Check my eligibility
What is being tested?
The HELPix Care Plan is being tested to see if it helps parents manage their children's care after leaving the hospital. It aims to reduce complications that could lead to readmission by providing better support during this transition period.See study design
What are the potential side effects?
Since this intervention involves a care plan rather than a drug, there aren't typical side effects. However, there may be unforeseen issues related to the implementation of the plan that could affect its effectiveness or family stress levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is 18 years old or younger.
Select...
My child is on or will be on daily medication after discharge.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visit 4 (day 30-45)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 4 (day 30-45)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of CMC with any type of post-discharge morbidity
Parent Adherence to Discharge Instructions
Parent Comprehension of Discharge Instructions
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
75 participants will be randomized to receive behavioral intervention, consisting of discharge counseling using the health literacy-informed discharge instructions
Group II: Usual CareActive Control1 Intervention
75 participants will receive standard care, consisting of verbal discharge counseling given by doctors and nurses supplemented by written instructions (all unstandardized).
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,515 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,353 Total Patients Enrolled
Alexander F Glick, MD, MSPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My caregiver is under 18 years old.I speak English or Spanish.My child is 18 years old or younger.I am the primary caregiver of a child with severe chronic conditions affecting multiple body systems.I am willing to be assigned to a treatment group by chance.I have trouble hearing.I am a parent.My child is on or will be on daily medication after discharge.I am willing and able to follow the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom does this clinical trial offer the opportunity to participate?
"Eligible candidates are those with CMC-diagnosed children, ranging in age from 18 to 99. This trial is currently accepting a cohort of 282 patients."
Answered by AI
Is the eligibility criterion for this research study restricted to adults aged 18 or above?
"This clinical trial is taking applications from individuals who are aged 18 and above, up until the age of 99."
Answered by AI
What is the scope of this research project in terms of participant numbers?
"Affirmative. Records located on clinicaltrials.gov affirm that this investigation is recruiting patients, having been posted on July 23rd 2021 and most recently amended a month ago in March 15th 2022. The trial requires 282 participants from just one medical centre to be enrolled."
Answered by AI
Are there slots available for volunteers in this clinical experiment?
"Yes, the information on clinicaltrials.gov attests to this medical trial's recruitment efforts. The study was first advertised on July 23rd 2021 and has most recently been revised on March 15th 2022. This research effort requires 282 volunteers from one facility."
Answered by AI
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