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OpenTrials
Completed

NCT Number: NCT03121651

Medication Management Among Individuals With Neurodevelopmental Disabilities

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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.

Primary outcomes

  1. 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

  1. Usefulness of the aspects of the RL-adaptive support

    Time frame: End of each phase, which lasts approximately 6 weeks

    Qualitative feedback

  2. Most and least helpful aspects of RL-adaptive support application

    Time frame: End of each phase, which lasts approximately 6 weeks

    Qualitative feedback

  3. Ease of use of RL-adaptive support application

    Time frame: End of each phase, which lasts approximately 6 weeks

    Qualitative feedback

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: M-MIND

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2017
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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