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Personlig mobil sundhedsplatform til fremme af fysisk aktivitet hos unge og unge voksne med cystisk fibrose (NUDGE)

4. november 2026 opdateret af: David Fedele, Nemours Children's Clinic

The goal of this clinical trial is to help adolescents and young adults between the ages of 13-25 with Cystic Fibrosis (CF), medically stable, able to speak and read English, and are not experiencing a CF - related exacerbation, who are already active to remain, or gradually encourage them to increase their levels of physical activity

Participants will be asked to utilize a smartphone program, called NUDGE that we have developed. NUDGE is a chatbot with evidence-based features known to help teens make progress toward health goal:

  • Set and review goals
  • Self-monitor progress
  • Provide feedback on goal attainment
  • Revise future goals

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The goal of this study is to conduct a 6-month delayed treatment pilot Trial with adolescents and young adults (AYA) ages 13-25 with Cystic Fibrosis (CF) or a CF related disorder) to establish feasibility and obtain data necessary to inform a Phase III efficacy trial. AYAs 18 years-old and caregivers of AYAs 13-17 years-old will complete the informed consent process. AYAs 13-17 years-old will be asked to assent to participate in the study. After completion of the baseline study measures and return of actigraphy monitors, staff will notify AYAs of their randomized assignment. AYAs receiving NUDGE will then begin receiving intervention content for 6 months. AYAs randomized to control will receive NUDGE at the conclusion of the Month 3 study visit. Study visits will occur at Months 0, 3, and 6 with staff masked to treatment assignment.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32207
        • Nemours Childrens Health

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

13 år til 25 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. 13-25 years old
  2. Has a verified CF diagnosis or CF-related disorder
  3. Medically stable (i.e., FEV1>30%, not experiencing a CF-related exacerbation)
  4. Speaks and reads English

Exclusion Criteria:

  1. Have a comorbidity limiting PA participation (e.g., neurological condition)
  2. Have a significant cognitive impairment that interferes with study completion
  3. Have any oxygen, CPAP or BiPAP requirement

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Uddannelse
Andet: Education

Individuals will receive educational materials about how to increase physical activity
Eksperimentel: NUDGE
Adfærdsmæssigt: NUDGE

Individuals in this condition will receive intervention content to promote physical activity.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment
Tidsramme: Baseline

Recruitment: Our recruitment goal is 30 AYAs with CF.
Baseline
Retention
Tidsramme: 3-month

Retention: Our criterion for success is no more than 20% attrition.
3-month
Engagement
Tidsramme: 3-month

Engagement: We will be considered engagement a success if AYAs in NUDGE respond to an average of 4/7 (57%) messages each week during the first 3 months that a participant uses NUDGE.
3-month
Acceptability
Tidsramme: 3-month

Acceptability: We will consider NUDGE acceptable if users report a satisfaction rating of ≥3 (mostly satisfied) on our modified Client Satisfaction Questionnaire and rate it as usable as ≥70% of other computerized systems on the System Usability Scale. We will also be attentive to themes in relation to the barriers and facilitators of using NUDGE and its success in promoting PA in interviews.
3-month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Actigraphy
Tidsramme: Baseline, 3-month, and 6-month

We will objectively measure AYA's moderate-to-vigorous PA for 7-days via ActiGraph wGT3X-BT accelerometers. All data will be processed using Actilife software. We will remove periods of non-wear and sleep; days with >10-hours of valid data during waking hours will be retained. Data will be binned into 15 second epochs and processed using the Chandler algorithm.
Baseline, 3-month, and 6-month
Lung Functioning
Tidsramme: Baseline, 3-month, and 6-month

Lung function will be assessed for 7-days via the AM1+ portable spirometer. AYAs will undergo a standardize training and complete three maximal effort blows every morning and evening. The main outcomes will be forced expiratory volume in one second (FEV1) percent predicted.
Baseline, 3-month, and 6-month
CF Quality of Life
Tidsramme: Baseline, 3-month, and 6-month

AYA CF-related quality of life will be assessed via the Cystic Fibrosis Questionnaire-Revised.
Baseline, 3-month, and 6-month

Samarbejdspartnere og efterforskere

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

Sponsor

Nemours Children's Clinic

Samarbejdspartnere

Cystic Fibrosis Foundation

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 (Faktiske)

18. februar 2025

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

20. september 2024

Først indsendt, der opfyldte QC-kriterier

25. september 2024

Først opslået (Faktiske)

27. september 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2158063
  • 003780A122 (Andet bevillings-/finansieringsnummer: Cystic Fibrosis Foundation)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Plans to share IPD will need to be discussed with the IRB.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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