Medication Management Among Individuals With Neurodevelopmental Disabilities (M-MIND)

University of Michigan

Status: Completed

Conditions: Spina Bifida; Cerebral Palsy

Treatments: Device: RL-adaptive application

Study type: Interventional

Funder types: Other

Identifiers

NCT03121651

90RE5012 (Other Grant/Funding Number)

HUM00107874 and HUM00139267

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

RL-adaptive application

Experimental group

Description:

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.

Treatment:

Device: RL-adaptive application