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| ID | Type | Description | Link |
|---|---|---|---|
| 90RE5012 | Other Grant/Funding Number | NIDILRR |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
The goal is to reduce the number of caregiver prompts necessary for the medication pillbox to be opened. |
| 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 |
| 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 |
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Inclusion Criteria:
For young adult:
For parent/caregiver:
Exclusion Criteria:
• Those who do not fulfill the inclusion criteria will be excluded from the study
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| Name | Affiliation | Role |
|---|---|---|
| Karen B Farris, PhD | Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
No plan to share IPD
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| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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Unblinded pilot study with 1 intervention arm
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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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |