Medication Management Among Individuals With Neurodevelopmental Disabilities

Study Overview
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Brief Summary
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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
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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: young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team, young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and 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.

Official Title
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Medication Management Among Individuals With Neurodevelopmental Disabilities

Conditions
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Spina Bifida, Cerebral Palsy

Intervention / Treatment
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* Device: RL-adaptive application


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Unblinded pilot study with 1 intervention arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RL-adaptive application<br>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. | Device: RL-adaptive application<br>* Up 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: young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team, young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prefer to continue to use RL-adaptive support after study is over | Qualitative feedback | at least 18 weeks after beginning study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usefulness of the aspects of the RL-adaptive support | Qualitative feedback | End of each phase, which lasts approximately 6 weeks | 
| Most and least helpful aspects of RL-adaptive support application | Qualitative feedback | End of each phase, which lasts approximately 6 weeks | 
| Ease of use of RL-adaptive support application | Qualitative feedback | End of each phase, which lasts approximately 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile technology, Reinforcement-learning, Medication management