- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01536509
Improving Medication Adherence in Pediatric Inflammatory Bowel Disease (TEAM)
24. januar 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
140
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
San Francisco, California, Forente stater, 94143
- University of California San Francisco Benioff Children's Hospital
-
-
Connecticut
-
Hartford, Connecticut, Forente stater, 06106
- Connecticut Children's Medical Center
-
-
Missouri
-
Kansas City, Missouri, Forente stater, 64108
- Children's Mercy Hospitals and Clinics
-
-
Ohio
-
Cincinnati, Ohio, Forente stater, 45229
- Cincinnati Children's Hospital Medical Center
-
Cincinnati, Ohio, Forente stater, 45221
- University of Cincinnati
-
Columbus, Ohio, Forente stater, 43205
- Nationwide Children's Hospital
-
-
Oklahoma
-
Stillwater, Oklahoma, Forente stater, 74074
- Oklahoma State University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
-
Pittsburgh, Pennsylvania, Forente stater, 15224
- Childrens Hospital Of Pittsburgh Of Upmc
-
-
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
11 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Telehealth Behavioral Treatment
|
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
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: 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
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. februar 2012
Primær fullføring (Faktiske)
31. mai 2016
Studiet fullført (Faktiske)
31. mai 2016
Datoer for studieregistrering
Først innsendt
16. februar 2012
Først innsendt som oppfylte QC-kriteriene
21. februar 2012
Først lagt ut (Anslag)
22. februar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R01HD067174 (U.S. NIH-stipend/kontrakt)
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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