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Medsma℞t Mobile Ed

7. oktober 2026 opdateret af: Olufunmilola Abraham

Implementering af Medsma-familier i akuttafdelingens indstilling: En spilbaseret tilgang til forbedring af opioidsikkerhed blandt unge og forældre

The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is:

• Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone?

Participants will, in addition to receiving opioid counseling:

  • Join an online meeting with research staff to test the smartphone-based intervention
  • Report demographic information
  • Complete surveys about opioids
  • Complete a family medication safety plan
  • Complete surveys after 3, 6, and 9 months

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

244

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Illinois
      • Rockford, Illinois, Forenede Stater, 61104
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Allie Hurst, MD
      • Madison, Wisconsin, Forenede Stater, 53718
        • East Madison Hospital
        • Kontakt:
        • Kontakt:
          • Kayla Zubke
          • Telefonnummer: 608-421-7367

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adults who receive an opioid prescription from a study Emergency Department, AND
  • who report having an adolescent, aged 12-18, living at home, AND
  • who speak and understand English
  • Each participant must have the ability to provide informed consent

Exclusion Criteria:

  • Adults who do not receive an opioid prescription from a study Emergency Department AND/OR
  • who do not have an adolescent, aged 12-18, living at home, AND/OR
  • who do not speak or understand English
  • Adults and/or adolescents who do not have the ability to provide informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention

This group will receive the intervention of interest, MedSMA℞T Mobile, in addition to standard opioid-related counseling. MedSMA℞T Mobile is a serious game (intended to educate while entertaining) focused on opioid safety.

MedSMA℞T Mobile is an innovative mobile digital health intervention that integrates technology-based learning to facilitate family communication and creation of a personalized Family Medication Safety Plan. The Family Medication Safety Plan (FMSP) is a tool for families to record important information about their medications and create a plan for safe use, storage, and disposal. Participants will play MedSMA℞T Mobile for up to 30 minutes at the first study visit.

Ingen indgriben: Control

This group will receive the standard opioid-related counseling that all patients receive when newly prescribed opioids in the emergency department.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Adolescent Opioid Safety and Learning (AOSL) scale score over 9 month study
Tidsramme: Baseline, 3, 6, and 9 months.

The fourth factor of the Adolescent Opioid Safety and Learning (AOSL) scale, Opioid Harm, measures understanding of negative social and professional effects of opioid misuse. Scores range from 3-15, where 3 indicates the lowest level of overall opioid harm awareness and 15 is the highest level.

Baseline, 3, 6, and 9 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Safe Opioid Storage Behaviour over 9 months
Tidsramme: Baseline, 3, 6, and 9 months.

This outcome contains 4 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, comprised of yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid storage behaviour) and the maximum is 4 (indicating most safe opioid storage behaviour).

Baseline, 3, 6, and 9 months.
Change in Opioid Disposal Behaviour over 9 months
Tidsramme: Baseline, 3, 6, and 9 months.

This outcome contains 6 items from the Wisconsin Strategic Prevention Framework Partnerships for Success Community Survey - V02, and includes yes/no questions. The minimum score for this scale is 0 (indicating least safe opioid disposal behaviour) and the maximum is 6 (indicating most safe opioid disposal behaviour).

Baseline, 3, 6, and 9 months.
Change in Medication Understanding and Use Self-Efficacy (MUSE) scale scores over 9 months
Tidsramme: Baseline, 3, 6, and 9 months.

This section covers the second factor, Learning About Medication, of the Medication Understanding and Use Self-Efficacy (MUSE) scale. This factor is comprised of 4 items, each scored 1-4. The minimum score is 4, and the maximum is 16. A score of 4 indicates lower understanding and self-efficacy in opioid use, whereas a score of 16 indicates highest level of understanding and self-efficacy in opioid use.

Baseline, 3, 6, and 9 months.
Change in Family Communication Behaviour Patterns over 9 months
Tidsramme: Baseline, 3, 6, and 9 months.

This includes both the parent and child versions of the 26-item, 2-factor scales. The first factor, Conversation orientation, contains 15 items. The second factor, Conformity orientation, contains 11 items. Items are scored from 1-5, where 1 is "Disagree Strongly" and 5 is "Agree Strongly". Scale scores are averages for the two scales, with each item contributing equally. The minimum and maximum average scores, therefore, cannot exceed 1 and 5, respectively.

Baseline, 3, 6, and 9 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Olufunmilola Abraham, PhD, University of Kentucky College of Pharmacy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2027

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

21. februar 2025

Først indsendt, der opfyldte QC-kriterier

21. februar 2025

Først opslået (Faktiske)

27. februar 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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