Recruiting

AUM

Sponsor:

Northwell Health

Code:

NCT06986863

Conditions

Intellectual and Developmental Disabilities

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Always Uniquely Me mobile phone application

Study Details

Brief summary:

The purpose of this research study is to compare the Always Uniquely Me (AUM) mobile application to regular medical care. The investigators want to know if AUM is helpful at decreasing use of restraints and improving experience in the emergency department (ED) for people with intellectual and developmental disabilities (PWIDD). The investigators will also be looking at how certain characteristics of the PWIDD participants may affect those outcomes.

Conditions

Intellectual and Developmental Disabilities

Study ID

NCT06986863

Start date

Sep 24, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria for primary participant/PWIDD (person with intellectual and/or developmental disability):

  • have visited a Northwell Health Emergency Department in the last 12 months
  • have a confirmed intellectual and/or developmental disability
  • must be 18 years of age or older at enrollment
  • have a smart phone or tablet that connects to the internet
  • have a preferred language of English

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Standard Care

This arm will not be given any interventions.

experimental: Always Uniquely Me (AUM) arm

Participants will receive access to the Always Uniquely Me app.

Interventions

Always Uniquely Me mobile phone application

The app will allow the user to organize their healthcare information and personal needs which can help improve communication with doctors, clinicians and first responders.

Primary outcome measure

  • Use of physical and/or chemical restraints during ED visits [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Sophia Jan Division Chief, MD, MSHP

(516) 465-4377sjan1@northwell.edu

Caren Steinway, LMSW, MPH

(516) 316-2530csteinway@northwell.edu

Locations

Cohen Children's Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Sophia Jan, MD, MSHP

516-465-5308sjan1@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • Intellectual and developmental disabilities
  • emergency department
  • restraint
  • restraint, physical
  • emergency department visits

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-05-19.