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Improving Medication Adherence in Pediatric Inflammatory Bowel Disease (TEAM)

24. januar 2020 opdateret af: Children's Hospital Medical Center, Cincinnati

Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease

The purpose of the study is to test an online behavioral intervention to improve medication adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be monitored for four weeks to determine how frequently their child's IBD medication is taken. Patient's taking less than 90% of medications will be randomized to one of two intervention conditions to complete intervention sessions online. The study consists of 4 online intervention sessions with topics differing by condition and 5 online assessments to complete quality of life questionnaires over a 14 month time frame.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The purpose of the study is to test the efficacy of a telehealth behavioral treatment (TBT) protocol to improve medication adherence in children and adolescents with IBD via a randomized controlled clinical trial. Participants in the TBT condition will be compared to those in an education only (EO) condition. In order to examine clinical significance of the intervention, treatment outcomes will include disease severity, HRQOL, and health care utilization. This randomized controlled clinical trial for nonadherence to medication randomizes participants to either the TBT or EO intervention condition, with assessments occurring at baseline, post-treatment, and 3-, 6-, and 12-month follow-up. Both conditions will participate in a self-guided educational intervention during week 6 of enrollment, with three intervention sessions at weeks 8, 10, and 12. A 4-week run-in phase immediately preceding randomization is utilized to establish participants' baseline adherence. Assessments will occur at week 5 (Baseline Assessment 1), week 14 (Post-treatment Assessment 2), and 3-, 6-, and 12-month post-treatment follow-up (Assessments 3, 4, and 5). Intervention topics will differ for each condition; however, the frequency of contact is equivalent across conditions.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

140

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
    • California
      • San Francisco, California, Forenede Stater, 94143
        • University of California San Francisco Benioff Children's Hospital
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06106
        • Connecticut Children's Medical Center
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108
        • Children's Mercy Hospitals and Clinics
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45221
        • University of Cincinnati
      • Columbus, Ohio, Forenede Stater, 43205
        • Nationwide Children's Hospital
    • Oklahoma
      • Stillwater, Oklahoma, Forenede Stater, 74074
        • Oklahoma State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Childrens Hospital Of Pittsburgh Of Upmc

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

11 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient is currently seen for care at one of the collaborating research sites: Cincinnati Children's Hospital Medical Center, Connecticut Children's Medical Center, Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of California San Francisco Benioff Children's Hospital, or Children's Mercy Hospitals and Clinics
  • Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis
  • Patient age between 11-18 years
  • Patient currently living at home
  • Patient currently prescribed at least one daily oral immunomodulator (e.g., 6-MP/azathioprine) and/or 5-ASA (e.g., mesalamine)in pill form
  • English fluency for patient and parents
  • Inclusion for Randomization: <90% adherence to immunomodulator and/or 5-ASA during four week run-in phase

Exclusion Criteria:

  • Diagnosis of pervasive developmental disorder in patient or parent
  • Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Telehealth Behavioral Treatment
Adfærdsmæssigt: Telehealth Behavioral Treatment (TBT)
Families in the TBT condition will receive three individually-tailored behavioral intervention sessions in addition to the online education intervention with 1) guided problem-solving and behavior management training tailored to the unique needs and/or barriers of the family, and 2) discussion of the patient's adherence since the previous session. In addition, patients in the TBT condition will be signed up for text message reminder service offered free of charge via www.mymedschedule.com. These are generic reminder text messages are used to assist with adherence in adolescents. Intervention sessions will be conducted via telehealth delivery with trained postdoctoral psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.
Aktiv komparator: Education Only
Adfærdsmæssigt: Education Only (EO)
Families in the EO condition will receive three individual sessions in addition to the online education intervention to review 1) online educational intervention material to answer questions participants have, 2) educational brochures from the Crohn's and Colitis Foundation of America (CCFA), which contain additional information (e.g., Guide for Parents, Living with IBD, Guide for Kids and Teenagers), and 3) general healthy lifestyle recommendations (e.g., sleep, exercise, etc.). Sessions will be conducted via telehealth delivery with trained postdoctoral clinical psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medication adherence
Tidsramme: 15 months
Medication adherence will be measured using electronic monitoring. The specific device is the MEMS TrackCap. Immunomodulators and/or mesalamine medications will be assessed.
15 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Health-related quality of life
Tidsramme: 15 months
The IMPACT III measure will be used for this assessment. This is an IBD-specific HRQOL assessment tool.
15 months
Disease Severity
Tidsramme: 15 months
The Pediatric Crohn's Disease Activity Index (PCDAI) and Partial Harvey-Bradshaw Index (PHBI) will be used to assess disease severity in patients with Crohn's disease. The Pediatric Ulcerative Colitis Index (PUCAI) will be used in patients with ulcerative colitis.
15 months
Health care utilization
Tidsramme: 15 months
Health care utilization will be assessed via medical chart review and all IBD-related hospital admissions, procedures, communications, clinic appointments, and other encounters with the health care system will serve as indicators of utilization.
15 months

Samarbejdspartnere og efterforskere

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Efterforskere

  • Ledende efterforsker: Kevin Hommel, Ph.D., Children's Hospital Medical Center, Cincinnati
  • Studiestol: Robert Baldassano, M.D., Children's Hospital of Philadelphia
  • Studiestol: Wallace Crandall, M.D., Nationwide Children's Hospital
  • Studiestol: Francisco Sylvester, M.D., Connecticut Children's Medical Center
  • Studiestol: Lee Denson, M.D., Children's Hospital Medical Center, Cincinnati
  • Studiestol: Michele Maddux, Ph.D., Children's Mercy Hospital Kansas City
  • Studiestol: Melvin Heyman, M.D., University of California San Francisco Benioff Children's Hospital
  • Studiestol: David Keljo, M.D., University of Pittsburgh

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. februar 2012

Primær færdiggørelse (Faktiske)

31. maj 2016

Studieafslutning (Faktiske)

31. maj 2016

Datoer for studieregistrering

Først indsendt

16. februar 2012

Først indsendt, der opfyldte QC-kriterier

21. februar 2012

Først opslået (Skøn)

22. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01HD067174 (U.S. NIH-bevilling/kontrakt)

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 .

Kliniske forsøg med Crohns sygdom

Kliniske forsøg med Telehealth Behavioral Treatment (TBT)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in New Zealand

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner