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

29 mars 2019 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

6

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Michigan
      • Ann Arbor, Michigan, Förenta staterna, 48109
        • University of Michigan

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Enhetens genomförbarhet
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Prefer to continue to use RL-adaptive support after study is over
Tidsram: at least 18 weeks after beginning study
Qualitative feedback
at least 18 weeks after beginning study

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Usefulness of the aspects of the RL-adaptive support
Tidsram: 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
Tidsram: 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
Tidsram: End of each phase, which lasts approximately 6 weeks
Qualitative feedback
End of each phase, which lasts approximately 6 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Michigan

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 november 2016

Primärt slutförande (Faktisk)

1 december 2018

Avslutad studie (Faktisk)

1 december 2018

Studieregistreringsdatum

Först inskickad

7 april 2017

Först inskickad som uppfyllde QC-kriterierna

19 april 2017

Första postat (Faktisk)

20 april 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 april 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 mars 2019

Senast verifierad

1 mars 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • HUM00107874 and HUM00139267
  • 90RE5012 (Annat bidrag/finansieringsnummer: NIDILRR)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

No plan to share IPD

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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