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Family Management of Type 1 Diabetes in Children

Family Management of Childhood Diabetes Study

This is a multi-center, randomized controlled trial to test whether a clinic-integrated, low intensity, multi-component behavioral intervention is effective in preventing the deterioration in glycemic control, treatment adherence, and quality of life that commonly occur during late childhood and early adolescence in youth with type 1 diabetes. The study will also examine mechanisms and processes that influence the effectiveness of family management of diabetes during this developmental period.

Studieoversikt

Detaljert beskrivelse

The purpose of this study is to test the effectiveness of a practical, low-cost, low-intensity behavioral intervention that can be integrated directly into diabetes clinic routines. The goal of the intervention is to prevent the deterioration in glycemic control, treatment adherence, and quality of life that often occur during the transition to adolescence in families of youth with type 1 diabetes. Four-hundred and eighty families (120 from each of the four sites) will be randomly assigned by the coordinating center to intervention or standard care conditions. Standard care will be the multidisciplinary management of type 1 diabetes as currently practiced at the clinical sites. Randomization will be stratified by main versus recent-onset subgroup, age, and for the main subgroup, baseline glycosylated hemoglobin level. Families will remain in their respective experimental conditions for 24 months. A trained health advisor will be responsible for interactions with parents and patients prior to each diabetes clinic visit (preparation phase), at the time of the diabetes clinic visit (consolidation phase) and by phone, e-mail, etc. after the clinic visit (follow-up phase). Using educational modules developed for the study, families will be engaged in problem identification and solving activities to foster improved disease management capabilities and improved parent-youth communication around and sharing of responsibility for diabetes management. Families will be assessed at home three times and in the clinic four times over the course of the study. Measures include parent, child, and family characteristics that may affect intervention effectiveness, targeted mediators, family interaction, management practices, and glycosylated hemoglobin (HbA1c). Primary outcomes are diabetes management adherence and metabolic control; secondary outcomes are quality of life, health status, and psychosocial status.

Studietype

Intervensjonell

Registrering (Faktiske)

422

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

    • Florida
      • Jacksonville, Florida, Forente stater, 32207-8426
        • Nemours Children's Clinic
    • Illinois
      • Chicago, Illinois, Forente stater, 60614
        • Children's Memorial Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02215
        • Joslin Diabetes Center
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Texas Children's Hospital

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

9 år til 14 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Child Inclusion Criteria:

  • Age 9.0 to <14.5.
  • Type 1 diabetes diagnosis (diagnosed by ADA criteria) for a minimum of 1 year for the main subgroup or 3 months for the recent onset subgroup.
  • Insulin dose greater than or equal to 0.5 u/kg/day for the main subgroup or 0.2 u/kg/day for the recent onset subgroup; with 2 or more daily injections or use of insulin pump.
  • Most recent A1c is >6.0% and <13.0%; <12.0% for those diagnosed for less than 1 year.
  • Willing to provide informed assent.

Parent/Family Environment Inclusion Criteria

  • Child lives in geographically stable home, no multiple foster homes, boarding school, or institutions expected in next 2 years.
  • The same 1 or 2 adult caregivers have accompanied the child to every diabetes clinic visit in the past year, and at least 1 caregiver agrees to participate in all aspects of the protocol (single-parent families, blended families, and separated parents will be eligible).
  • Home has telephone access.
  • Child had at least 2 clinic visits within last 12 months.
  • Parent and child willing to come to clinic every 3 months for duration (2 years) of study.
  • If a family has more than one eligible child, all qualifying children who provide consent/assent will participate in assessment and intervention or control activities; however, only the oldest qualifying child will be included in statistical analyses.

Child Exclusion Criteria:

  • Presence of a major chronic diseases (except well-controlled thyroid, asthma, celiac).
  • Presence of a major visual/auditory impairments.
  • Child is in a self-contained special education class throughout the school day.
  • Record of inpatient hospitalization for mental disorder in past six months including substance abuse rehabilitation, eating disorder units or day treatment programs. Current diagnosis of eating disorder. History of anti-psychotic medications for the past 6 months.
  • Diagnosis of mental retardation.
  • Unable to read and write English at 2nd grade level.
  • Children who are currently enrolled in any intervention study are not eligible for enrollment. Those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. However, children who were in a standard care control group in an intervention study are eligible once they have completed all scheduled study follow-ups. Children cannot enroll in another intervention study during the course of this study. Enrollment of children who are currently participating in another observational study will be at the discretion of the site principal investigator.

Parent/Family Environment Exclusion Criteria

  • Family has plans to re-locate out of area within the next 2 years of the study.
  • Participating caretaker is currently undergoing treatment for substance abuse.
  • Participating caretaker has been hospitalized in past 6 months for mental disorder.
  • Participating caretaker has history of psychosis.
  • Families who are currently enrolled in any intervention study are not eligible for enrollment. Those who have been in an intervention arm of a trial of a behavioral, psychological or psychoeducational intervention and concluded their study follow-up within the past 12 months are also ineligible to participate. However, families who were in a standard care control group in an intervention study are eligible once they have completed all scheduled study follow-ups. Families cannot enroll in another intervention study during the course of this study. Enrollment of families who are currently participating in another observational study will be at the discretion of the site principal investigator.

The family must reside within 90 miles (one-way) of the clinic (main or satellite), or agree to meet at a mutually agreed upon closer location for conduct of the home assessment.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: family diabetes management intervention
A trained health advisor will be responsible for interactions with parents and patients prior to each diabetes clinic visit (Preparation Phase), at the time of the diabetes clinic visit (Consolidation Phase) and by phone, e-mail, etc. after the clinic visit (Follow-up Phase). Using educational modules developed for the study, families will be engaged in problem identification and solving activities to improve shared parent-youth responsibility for diabetes management and foster increased adolescent's independent management capabilities.
a clinic-integrated, low intensity, multi-component behavioral intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
glycemic control
Tidsramme: 1/2006-3/2009
HbA1c
1/2006-3/2009
treatment adherence
Tidsramme: 1/2006-3/2009
Diabetes Self Management Profile
1/2006-3/2009

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
quality of life
Tidsramme: 1/2006-3/2009
PedsQL Diabetes
1/2006-3/2009

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Bruce Simons-Morton, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

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. januar 2006

Primær fullføring (Faktiske)

1. mars 2009

Studiet fullført (Faktiske)

1. mars 2009

Datoer for studieregistrering

Først innsendt

5. januar 2006

Først innsendt som oppfylte QC-kriteriene

5. januar 2006

Først lagt ut (Anslag)

9. januar 2006

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

13. mai 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2011

Sist bekreftet

1. april 2011

Mer informasjon

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. .

Kliniske studier på Diabetes mellitus, type 1

Kliniske studier på family diabetes management intervention

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