- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03414177
Telehealth Enhanced Asthma Management (TEAM)
6. oktober 2020 opdateret af: Arkansas Children's Hospital Research Institute
This study will conduct a 12-month randomized trial with 48 pediatric patients (aged 6-18 years) with persistent asthma to compare outcomes among patients with follow-up visits managed via telemedicine (TM) vs. in-person (IP) visits.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The overarching hypothesis is that utilization of TM for asthma follow-up will result in improved clinical outcomes such as Asthma Control Test (ACT) scores, lung function and medication adherence compared to participants receiving IP follow-up care.
The Investigator also hypothesize that TM follow-up will result in higher caregiver satisfaction because families will be able to receive quality subspecialty care in their community (TM) compared to those who travel a distance to receive care (IP).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Arkansas
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Little Rock, Arkansas, Forenede Stater, 72202
- Arkansas Children's Hospital Research Institute
-
-
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
6 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- age ≥6- and ≤18 years
- persistent asthma as defined by national guidelines standards
- receives care at an ACH asthma subspecialty clinic
- reside ≤1.5 hour drive from Jonesboro, Springdale, Texarkana, or Fort Smith, AR
Exclusion Criteria:
- Significant underlying respiratory disease other than asthma, such as cystic fibrosis
- significant co-morbid conditions, such as individuals with developmental or physical impairments that could interfere with the ability to communicate via interactive video
- current smoker
- severe asthma exacerbation requiring intubation in the past 12 months
- no access to a smartphone or internet
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Telemedicine Group
Telemedicine participants will have asthma subspecialty follow-up visits conducted via real-time audio and video conferencing in conjunction with electronic examination peripherals and remote pulmonary function testing (PFT).
Participants will receive a survey link to complete an electronic survey to assess Asthma Control Test (ACT) score, healthcare utilization, and satisfaction.
|
Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
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Aktiv komparator: In-Person Group
In-Person participants will have asthma subspecialty follow-up visits at a subspecialty clinic.
They will receive pulmonary function testing (PFT).
Participants will receive a survey link to complete an electronic survey to assess Asthma Control Test (ACT) score, healthcare utilization, and satisfaction.
|
Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean difference in ACT score at the final assessment (12 months) after adjusting for baseline
Tidsramme: At baseline and 12 months
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ACT is used for symptoms monitoring as per guidelines and has been identified as an appropriate asthma control composite score in clinical research.
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At baseline and 12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Routine Follow up Asthma Visit
Tidsramme: At baseline, 4 months, 8 months, 12 months
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Physical examination to assess current asthma problems, symptoms, medication and the child's overall health.
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At baseline, 4 months, 8 months, 12 months
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Lung Function via Spirometry
Tidsramme: Baseline and 12 months
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Spirometry
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Baseline and 12 months
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Airway Inflammation via Spirometry
Tidsramme: Baseline and 12 months
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Spirometry
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Baseline and 12 months
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Healthcare Utilization
Tidsramme: At baseline, 4 months, 8 months, 12 months
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Patient report of the number of acute exacerbation in the past 12 months resulting in hospitalizations, emergency room or sick visits or steroid use.
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At baseline, 4 months, 8 months, 12 months
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Medication Adherence
Tidsramme: At baseline, 4 months, 8 months, 12 months
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Adherence will be defined as receiving ≥3 controller medication refills/6 months or achieving an Asthma Medication Ratio (AMR) of ≥0.5 based on national asthma guidelines.
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At baseline, 4 months, 8 months, 12 months
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Rescue Medication Use
Tidsramme: At baseline, 4 months, 8 months, 12 months
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Assessment of rescue medication use by caregiver report.
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At baseline, 4 months, 8 months, 12 months
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Clinic Visit Attendance Rate
Tidsramme: At baseline, 4 months, 8 months, 12 months
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Participant clinic attendance / Completion rate for Telemedicine and In-Person group.
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At baseline, 4 months, 8 months, 12 months
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Visit Satisfaction
Tidsramme: At baseline, 4 months, 8 months, 12 months
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Participant report of satisfaction with asthma follow up visit
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At baseline, 4 months, 8 months, 12 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Tamara T. Perry, MD, Arkansas Children's Research Institute
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)
6. marts 2018
Primær færdiggørelse (Faktiske)
8. august 2019
Studieafslutning (Faktiske)
1. oktober 2019
Datoer for studieregistrering
Først indsendt
9. januar 2018
Først indsendt, der opfyldte QC-kriterier
22. januar 2018
Først opslået (Faktiske)
29. januar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. oktober 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. oktober 2020
Sidst verificeret
1. oktober 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 207015
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