Spina BifidaM-MINDNCT03121651
Medication Management Among Individuals With Neurodevelopmental Disabilities
A study testing RL-adaptive application in people with Spina Bifida and Cerebral Palsy, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Spina Bifida, Cerebral Palsy
- What is being tested?
- RL-adaptive application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- Those who do not fulfill the inclusion criteria will be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- 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.
- Conditions
- Spina Bifida, Cerebral Palsy
- Being tested
- RL-adaptive application
- Keywords
- Mobile technology, Reinforcement-learning, Medication management
- Medical subject headings
- Spinal Dysraphism, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RL-adaptive applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RL-adaptive application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prefer to continue to use RL-adaptive support after study is over
Qualitative feedback
Measured: at least 18 weeks after beginning study
Secondary outcomes (3)
Usefulness of the aspects of the RL-adaptive support
Qualitative feedback
Measured: End of each phase, which lasts approximately 6 weeks
Most and least helpful aspects of RL-adaptive support application
Qualitative feedback
Measured: End of each phase, which lasts approximately 6 weeks
Ease of use of RL-adaptive support application
Qualitative feedback
Measured: End of each phase, which lasts approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start11 Nov 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Unblinded pilot study with 1 intervention arm
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Farris, PhD., University of Michigan
- Investigators
- Karen B Farris, PhD, Principal investigator, Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121651
- Sponsor's protocol ID
- HUM00107874 and HUM00139267
- Other IDs
- 90RE5012
- Acronym
- M-MIND
- Status last verified
- Mar 2019
- First submitted
- 7 Apr 2017
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Management Among Individuals With Neurodevelopmental Disabilities
- ClinicalTrials.gov ID
- NCT03121651
- Acronym / sponsor ID
- M-MIND / HUM00107874 and HUM00139267
- Conditions
- Spina Bifida, Cerebral Palsy
- Keywords
- Mobile technology, Reinforcement-learning, Medication management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 20 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Unblinded pilot study with 1 intervention arm
| Arm | Type | Receives |
|---|---|---|
| RL-adaptive application | Experimental | Device: RL-adaptive applicationDyad 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not fulfill the inclusion criteria will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RL-adaptive applicationUp 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. | Device | RL-adaptive application |
Primary outcome
Prefer to continue to use RL-adaptive support after study is over
Time frame: at least 18 weeks after beginning study
Qualitative feedback
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- Individual participant dataSharing planned: No. No plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen B Farris, PhD principal investigator
Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RL-adaptive application in people with Spina Bifida and Cerebral Palsy, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prefer to continue to use RL-adaptive support after study is over (time frame: at least 18 weeks after beginning study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.