Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03121651
Brief 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.
Study:
NCT03121651
Study Brief:
Protocol Section:
NCT03121651