Medication Management Among Individuals With Neurodevelopmental Disabilities

Not Applicable

Completed

• Conditions: Spina Bifida; Cerebral Palsy
• Interventions: Device: RL-adaptive application

• Registration Number: NCT03121651
• Lead Sponsor: University of Michigan

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 Timeline

• Study Start: 2016-11-11
• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-20
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

For young adult:

• Diagnosed with cerebral palsy or spina bifida and previously enrolled in HUM00081812
• Age 18-26 years-old
• Having mild-moderate cognition based on consultation with the investigators and the results of the following tests: iBRIEF Metacognition index T-Score, CVLT List A Free Recall T Score, ReyO Organization T-Score, PPVT Scaled Score, Tower Scaled Score, TRAQ question 4: Do participants take medications correctly and on their own?
• Having adequate physical dexterity (to be able to open a pill box and use an iPad/tablet)
• Taking two or more routine oral medicines in pill formulation
• Being able to take capsules or tablets
• Still living at home with their parent/legal guardian
• Have Wi-Fi/Internet access at home

For parent/caregiver:

• Being the parent/legal guardian of a person with aforementioned disability
• Owning a cell phone
• Have Wi-Fi/Internet access at home

Read More

Exclusion Criteria

• Those who do not fulfill the inclusion criteria will be excluded from the study

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RL-adaptive application	RL-adaptive application	Dyad is comprised of individual with disability (spina bifida or cerebral palsy) and the respective parent/legal guardian (also referred to as caregivers). Young adult will use the RL-adaptive support application that the investigators are developing to help manage medications.

Primary Outcome Measures

Name	Time	Method
Prefer to continue to use RL-adaptive support after study is over	at least 18 weeks after beginning study	Qualitative feedback

Secondary Outcome Measures

Name	Time	Method
Most and least helpful aspects of RL-adaptive support application	End of each phase, which lasts approximately 6 weeks	Qualitative feedback
Usefulness of the aspects of the RL-adaptive support	End of each phase, which lasts approximately 6 weeks	Qualitative feedback
Ease of use of RL-adaptive support application	End of each phase, which lasts approximately 6 weeks	Qualitative feedback

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States