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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Spina Bifida
• Intervention / Treatment: Device: RL-adaptive application

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: RL-adaptive application; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Karen B Farris, PhD, Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 19, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Mobile technology; Medication management; Reinforcement-learning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Brain Damage, Chronic; Nervous System Malformations; Neural Tube Defects; Cerebral Palsy; Spinal Dysraphism
• Other Study ID Numbers: HUM00107874 and HUM00139267; 90RE5012 (Other Grant/Funding Number: NIDILRR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No