Clinical Trials Directory

Trials / Completed

CompletedNCT03121651

Medication Management Among Individuals With Neurodevelopmental Disabilities

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
6 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

This is a pilot study to develop a reinforcement learning (RL)-adaptive visual and interactive support application (hereafter RL-adaptive support) to help young adults with spina bifida or cerebral palsy become more independent with medication management. Individuals with disabilities who are empowered to manage several aspects of their lives can ultimately be better integrated into and contribute more to society.

Detailed description

In this study, an application will be iteratively developed and tested using RL-adaptive support for young adults with disabilities, with the goal to promote the transition to independent self-medication administration among young adults with cerebral palsy and spina bifida. Stochastic mathematical models of how individuals with varying levels of executive function and psychomotor skills will respond to the interventions (i.e. the different types and formats of messages) of the RL-adaptive support will be developed. Up to 6 dyads of individuals with disabilities and their caregivers were intended to be recruited to collaborate in defining the features and content of the RL-adaptive support. The investigators recruited 3 dyads. The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each: 1. young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team, 2. young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and 3. young adult uses the electronic medication pillbox + the RL-adaptive support including push notifications in the form of text messages + caregiver uses the pillbox opening notification app The goal was to reduce the number of caregiver prompts necessary for the medication pillbox to be opened. Using these data, the number and type of prompts necessary for the caregiver to open the electronic pillbox can be determined. In case the young adult does not open the electronic pillbox within two hours, the caregiver will be notified so that pills are not missed. In each step, the useful features of the system will be determined via qualitative and quantitative feedback with specific suggestions about how to improve this supportive system.

Conditions

Interventions

TypeNameDescription
DEVICERL-adaptive applicationUp to 6 dyads of individuals with disabilities and their caregivers will be recruited to collaborate in defining the features and content of the RL-adaptive support. The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each: 1. young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team, 2. young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and 3. young adult uses the electronic medication pillbox + the RL-adaptive support including push notifications in the form of text messages + caregiver uses the pillbox opening notification app. The goal is to reduce the number of caregiver prompts necessary for the medication pillbox to be opened.

Timeline

Start date
2016-11-11
Primary completion
2018-12-01
Completion
2018-12-01
First posted
2017-04-20
Last updated
2019-04-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03121651. Inclusion in this directory is not an endorsement.