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Teen Asthma Control Encouraging a Healthier Lifestyle (TAC)

2. august 2018 opdateret af: Christine Joseph, Henry Ford Health System

Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents

Little guidance is given to physicians caring for obese adolescents with asthma, however, findings suggest that interventions designed to achieve asthma control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g., low self-esteem, depression, and low quality of life) successful interventions should incorporate a patient-centered approach. The proposed study design is a clinic-based, randomized controlled trial (RCT) in teens with a history of asthma and who are overweight or obese.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Asthma that has persisted in adolescents is likely to persist into adulthood. For 25-30% of Americans, adolescence is also the period at which they experience their greatest weight gain, particularly as they approach the final stages of puberty. Asthma management may be more of a challenge in the overweight adolescent compared to a normal weight youth. Asthma related morbidity is increased in overweight patients, reflected in higher health care utilization for this subgroup. Little guidance is given to physicians caring for obese adolescents with asthma, but findings suggest that interventions designated to achieve control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g. low self-esteem, depression and low quality of life) successful interventions should incorporate a patient-centered approach.

Patient-centered care (or patient focused care) involves a partnership between the patient and the physician, shared discussion making, as well as productive communication and health promotion. The objective of this project is to collect the information necessary to develop a tailored discussion guide for use by the physician caring for the obese teen with asthma. Project results will provide an evidence base for the development and evaluation of additional patient-centered health interventions for obese adolescents with asthma. The investigators will conduct this study among patients whom eligibility can be determined using the electronic medical record (EMR). The specific aims of this proposal are to:

Qualitatively collect information on outcomes important to obese adolescents with asthma:

Create a tailored discussion guide that incorporates patient preferences and treatment goals that can be used by providers caring for overweight adolescents with asthma:

Conduct a randomized trial to determine if patient-centered and clinical outcomes improve for patients whose physicians use the tailored discussion guide compared to those who do not.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

44

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
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford System

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 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • BMI >85th Percentile & Diagnosed with asthma; using a modification of Healthcare Effectiveness Data and Information Set (HEDIS) criteria:
  • At least one emergency department visit with a principal diagnosis of asthma, or
  • At least one acute inpatient claim/encounter with asthma as the principal diagnosis or at least four outpatient visits with an asthma diagnosis and at least or
  • At least four asthma four outpatient visit with an asthma diagnosis and at least two asthma medications dispensed, or
  • At least four asthma medications dispensed in the last 12 month

Exclusion Criteria:

  • Does not meet eligibility criteria for weight and/or asthma;
  • Currently enrolled in another investigational asthma management /education/weight management trial.

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Standard Control
Teens in the control group will receive standard or usual care as provided by their physician.
Andet: Standard Control
Teens in the control group will receive standard or usual care as provided by their physician.
Andet: Intervention
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
Adfærdsmæssigt: a provider administered, tailored discussion guide
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Asthma Control Test
Tidsramme: 12 months of enrollment
A validated measure of asthma control
12 months of enrollment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body Mass Index (BMI)
Tidsramme: 12 months of enrollment
changes in participant weight
12 months of enrollment

Samarbejdspartnere og efterforskere

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

Sponsor

Henry Ford Health System

Efterforskere

  • Ledende efterforsker: Christine Joseph, PhD, Henry Ford Health System

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. august 2015

Primær færdiggørelse (Faktiske)

1. februar 2018

Studieafslutning (Faktiske)

1. februar 2018

Datoer for studieregistrering

Først indsendt

12. oktober 2015

Først indsendt, der opfyldte QC-kriterier

13. oktober 2015

Først opslået (Skøn)

14. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 8298 (CTEP)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Uafklaret

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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