Medication Management Among Individuals With Neurodevelopmental Disabilities

NCT ID: NCT03121651

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-11
• Study Completion Date: 2018-12-31

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.

Conditions

Spina Bifida; Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

RL-adaptive application

Intervention Type: 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.

Interventions

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:

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Karen Farris, PhD.

Charles R. Walgreen III Professor of Pharmacy Administration

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen B Farris, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

90RE5012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HUM00107874 and HUM00139267

Identifier Type: -

Identifier Source: org_study_id