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

29. mars 2019 oppdatert av: Karen Farris, PhD., University of Michigan
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

6

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prefer to continue to use RL-adaptive support after study is over
Tidsramme: at least 18 weeks after beginning study
Qualitative feedback
at least 18 weeks after beginning study

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Usefulness of the aspects of the RL-adaptive support
Tidsramme: End of each phase, which lasts approximately 6 weeks
Qualitative feedback
End of each phase, which lasts approximately 6 weeks
Most and least helpful aspects of RL-adaptive support application
Tidsramme: End of each phase, which lasts approximately 6 weeks
Qualitative feedback
End of each phase, which lasts approximately 6 weeks
Ease of use of RL-adaptive support application
Tidsramme: End of each phase, which lasts approximately 6 weeks
Qualitative feedback
End of each phase, which lasts approximately 6 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Michigan

Etterforskere

  • Hovedetterforsker: Karen B Farris, PhD, Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. november 2016

Primær fullføring (Faktiske)

1. desember 2018

Studiet fullført (Faktiske)

1. desember 2018

Datoer for studieregistrering

Først innsendt

7. april 2017

Først innsendt som oppfylte QC-kriteriene

19. april 2017

Først lagt ut (Faktiske)

20. april 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HUM00107874 and HUM00139267
  • 90RE5012 (Annet stipend/finansieringsnummer: NIDILRR)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

No plan to share IPD

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Cerebral parese

Kliniske studier på RL-adaptive application

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