---
title: Medication Management Among Individuals With Neurodevelopmental Disabilities
nct_id: NCT03121651
overall_status: COMPLETED
phase: NA
sponsor: University of Michigan
study_type: INTERVENTIONAL
primary_condition: Spina Bifida
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03121651.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03121651"
ct_last_update_post_date: 2019-04-02
last_seen_at: "2026-05-12T06:23:59.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Medication Management Among Individuals With Neurodevelopmental Disabilities

**NCT ID:** [NCT03121651](https://clinicaltrials.gov/study/NCT03121651)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 6
- **Lead Sponsor:** University of Michigan
- **Conditions:** Spina Bifida, Cerebral Palsy
- **Start Date:** 2016-11-11
- **Completion Date:** 2018-12
- **CT.gov Last Update:** 2019-04-02

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 99 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **RL-adaptive application** (EXPERIMENTAL) — 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.

## Interventions

- **RL-adaptive application** (DEVICE) — 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:

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.

## Primary Outcomes

- **Prefer to continue to use RL-adaptive support after study is over** _(time frame: at least 18 weeks after beginning study)_ — Qualitative feedback

## Secondary Outcomes

- **Usefulness of the aspects of the RL-adaptive support** _(time frame: End of each phase, which lasts approximately 6 weeks)_
- **Most and least helpful aspects of RL-adaptive support application** _(time frame: End of each phase, which lasts approximately 6 weeks)_
- **Ease of use of RL-adaptive support application** _(time frame: End of each phase, which lasts approximately 6 weeks)_

## Locations (1)

- University of Michigan, Ann Arbor, Michigan, United States

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of michigan|ann arbor|michigan|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03121651.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03121651*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*