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A Randomized Trial Examining the Effectiveness of Mobile-Based Asthma Action Plans vs. Paper Asthma Action Plans (PEAK2)

The purpose of this study is to see if using a mobile phone application asthma action plan will help improve asthma management.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

The investigators propose to conduct a randomized trial to examine the effectiveness of a mobile-based Asthma Action Plan that will meet the national guidelines recommendation for individualized Asthma Action Plan treatment plans. The mobile app will provide immediate instructions and feedback once data is entered by the participants. This is an randomized trial which will be compared with an paper asthma action plan. Participants will be randomized through a statistical table. The mobile app will be password and Health Information Portability and Protection Act protected.

Studietype

Intervensjonell

Registrering (Faktiske)

34

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Arkansas
      • Little Rock, Arkansas, Forente stater, 72202
        • Arkansas Children's Hospital Research Institute

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

12 år til 17 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age ≥ 12 and ≤ 17 years.
  • Access to Apple or Android based smart phone
  • Mild to severe persistent asthma or poorly controlled asthma (see definitions below).

    o A different assessment of eligibility will be performed depending on whether or not the parent reports use of a preventive asthma medication at baseline. This is consistent with 2007 National Asthma Education Prevention Program recommendations that make a strong distinction between classifying asthma severity (for children not using preventive medications) and assessing control (for children using preventive medications). If a child has used a preventive medication in the past, but reports no use of the medication in the prior 3 months, we will assess severity.)

  • Children not using a preventive medication at baseline: Assess for mild persistent to severe persistent asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine severity:

    • An average of >2 days per week with asthma symptoms
    • >2 days per week with rescue medication use
    • ≥2 nights per month awakened with nighttime symptoms
    • Minor limitation of activity
    • ≥2 episodes of asthma during the past year that have required systemic corticosteroids
  • Children using a preventive medication at baseline: Assess for poorly controlled asthma. Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting room) will determine control:

    • An average of >2 days per week with asthma symptoms
    • >2 days per week with rescue medication use
    • ≥2 nights per month awakened with nighttime symptoms
    • Some limitation of activity
    • ≥2 episodes of asthma during the past year that have required systemic corticosteroids.

Exclusion Criteria:

  • Significant underlying respiratory disease other than asthma (such as cystic fibrosis or chronic lung disease) that could potentially interfere with asthma-related outcome measures.
  • Significant co-morbid conditions (such as moderate to severe developmental delay, i.e. special education classroom or diagnosis) that could preclude participation in an education-based intervention.
  • Inability to speak or understand English (child or parent).
  • Children in foster care or other situations in which consent cannot be obtained from a guardian.
  • Prior enrollment in 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: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Paper Asthma Action Plan
Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.
Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.
Eksperimentell: Mobile Phone
Participants will record asthma symptoms, medication usage, and peak flow data on their phones.
Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.
Andre navn:
  • IPhone and Android mobile phones

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Asthma Control Test Scores
Tidsramme: Baseline and Six months
The Asthma Control Test™ (ACT) is a 5 question health survey used to measure asthma control in individuals 12 years of age and older. The total sum scores range from 5-25. Higher scores mean that asthma is more controlled. The ACT is an efficient, reliable, and valid method of measuring asthma control, with or without, lung functioning measures such as spirometry. ACT helps identify and detect asthma patients who are not well controlled. ACT scores were examined pre- and post-intervention. A score total of 19 or less means asthma may not be well controlled. The timeframe is during the past 4 weeks. The scale range for Question 1 is "all the time" (1) to "none of the time" (5); Question 2 range: "more than once a day" (1) to "not at all" (5); Question 3 range: "4 or more nights a week" (1) to "not at all" (5); Question 4 range: "3 or more times per day" (1) to "not at all" (5); Question 5 range: "not controlled at all" (1) to "completely controlled" (5).
Baseline and Six months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Asthma Self-Efficacy Scores
Tidsramme: Baseline and Six months
The Child Self-Efficacy instrument is a 14 item validated questionnaire designed to measure the child's self-efficacy with regard to attack prevention and attack management. The child will be required to select one of 5 responses ranging from "not at all sure" (1 point); "a little bit sure" (2 points); "fairly sure" (3 points); "quite sure" (4 points) to "completely sure" (5 points). Total score range from 14-70. The attack prevention scale range from 6-30 and attack management range from 8-40. The higher score represent a greater degree of self-efficacy. The Cronbach's α reliability = 0.75. The child self-efficacy questionnaire will be administered at baseline (pre-intervention) and at the end of the intervention (post-intervention).
Baseline and Six months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Comparison of Participant Usage Rates Between Mobile and Paper Asthma Action Plans
Tidsramme: Six months
We measured the participant usage rates by frequency of a mobile asthma action plan compared to usage rates of a paper asthma action plan. No mobile usage data was collected for the paper asthma plan group; and no paper usage data was collected for mobile phone group.
Six months

Samarbeidspartnere og etterforskere

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

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Tamara T Perry, MD,FAAP, University of Arkansas

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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

1. mars 2014

Primær fullføring (Faktiske)

1. april 2015

Studiet fullført (Faktiske)

1. april 2015

Datoer for studieregistrering

Først innsendt

14. januar 2014

Først innsendt som oppfylte QC-kriteriene

17. mars 2014

Først lagt ut (Anslag)

19. mars 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. juni 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. juni 2018

Sist bekreftet

1. juni 2018

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

There is no plan to share individual participant data.

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. .

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