- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00273286
Family Management of Type 1 Diabetes in Children
11 maj 2011 uppdaterad av: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
422
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32207-8426
- Nemours Children's Clinic
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60614
- Children's Memorial Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02215
- Joslin Diabetes Center
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Texas Children's Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
9 år till 14 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
glycemic control
Tidsram: 1/2006-3/2009
|
HbA1c
|
1/2006-3/2009
|
treatment adherence
Tidsram: 1/2006-3/2009
|
Diabetes Self Management Profile
|
1/2006-3/2009
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
quality of life
Tidsram: 1/2006-3/2009
|
PedsQL Diabetes
|
1/2006-3/2009
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Bruce Simons-Morton, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Temmen CD, Lu R, Gee BT, Chen Z, Nansel TR. Latent classifications of parental involvement in diabetes management for youth with type 1 diabetes: A randomized clinical trial. Pediatr Diabetes. 2022 Nov;23(7):1133-1142. doi: 10.1111/pedi.13397. Epub 2022 Aug 19.
- Nansel TR, Thomas DM, Liu A. Efficacy of a Behavioral Intervention for Pediatric Type 1 Diabetes Across Income. Am J Prev Med. 2015 Dec;49(6):930-4. doi: 10.1016/j.amepre.2015.05.006. Epub 2015 Jul 29.
- Nansel TR, Lipsky LM, Iannotti RJ. Cross-sectional and longitudinal relationships of body mass index with glycemic control in children and adolescents with type 1 diabetes mellitus. Diabetes Res Clin Pract. 2013 Apr;100(1):126-32. doi: 10.1016/j.diabres.2012.12.025. Epub 2013 Jan 20.
- Nansel TR, Iannotti RJ, Liu A. Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Pediatrics. 2012 Apr;129(4):e866-73. doi: 10.1542/peds.2011-2858. Epub 2012 Mar 5.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2006
Primärt slutförande (Faktisk)
1 mars 2009
Avslutad studie (Faktisk)
1 mars 2009
Studieregistreringsdatum
Först inskickad
5 januari 2006
Först inskickad som uppfyllde QC-kriterierna
5 januari 2006
Första postat (Uppskatta)
9 januari 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 maj 2011
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 maj 2011
Senast verifierad
1 april 2011
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FMOD
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Diabetes mellitus, typ 1
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.AvslutadDiabetes mellitus, typ 1 | Typ 1-diabetes | Diabetes typ 1 | Typ 1-diabetes mellitus | Autoimmun diabetes | Diabetes mellitus, insulinberoende | Ungdomsdiabetes | Diabetes, autoimmun | Insulinberoende diabetes mellitus 1 | Diabetes mellitus, insulinberoende, 1 | Diabetes mellitus, spröd | Diabetes mellitus, juvenil-debut och andra villkorFörenta staterna
-
University of California, San FranciscoJuvenile Diabetes Research FoundationAvslutadTyp 1-diabetes mellitus | Diabetes mellitus, typ I | Insulinberoende diabetes mellitus 1 | Diabetes mellitus, insulinberoende, 1 | IDDMFörenta staterna, Australien
-
Capillary Biomedical, Inc.AvslutadDiabetes mellitus, typ 1 | Typ 1-diabetes | Typ 1-diabetes mellitus | Diabetes mellitus, insulinberoende, 1Australien
-
SanofiAvslutadTyp 1-diabetes mellitus-typ 2-diabetes mellitusUngern, Ryska Federationen, Tyskland, Polen, Japan, Förenta staterna, Finland
-
Hanmi Pharmaceutical Company LimitedOkändTyp 2 diabetes mellitus | Typ 1 diabetes mellitusFörenta staterna
-
Joslin Diabetes CenterCambridge Medical Technologies, LLCAvslutadTyp 2-diabetes mellitus | Typ 1 diabetes mellitusFörenta staterna
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)AvslutadTyp 1-diabetes mellitus | T1DM | T1D | Nyuppkommen typ 1-diabetes mellitusFörenta staterna, Australien
-
Spiden AGDCB Research AGAvslutadTyp 1-diabetes mellitus | Typ 1-diabetes mellitus med hypoglykemi | Typ 1-diabetes mellitus med hyperglykemiSchweiz
-
HealthCore-NERIYale UniversityAvslutadTyp 1 diabetes | Typ 1 diabetes mellitusFörenta staterna
-
AstraZenecaAvslutadTyp 2-diabetes mellitus | Typ 1-diabetes mellitusFörenta staterna
Kliniska prövningar på family diabetes management intervention
-
Ersta Sköndal University CollegeAvslutad
-
Mental Health Services in the Capital Region, DenmarkTrygFonden, Denmark; Sektion for Tværsektoriel forskning - Region HovedstadenRekryteringBarn | Föräldraskap | Elasticitet | Mental sjukdom | Förebyggande | FamiljDanmark
-
Children's Hospital Medical Center, CincinnatiOffice of Head StartAvslutad
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)AvslutadTrotssyndrom | BeteendestörningKanada
-
IWK Health CentreMcGill University; Canadian Institutes of Health Research (CIHR); University... och andra samarbetspartnersAktiv, inte rekryterandeNeuropsykiatriska funktionsnedsättningar | BeteendestörningarKanada
-
Rahel NaefSwiss National Science FoundationAktiv, inte rekryterandeLivskvalité | Posttraumatisk stressyndrom | Depression, ångest | Postintensivvårdssyndrom | Familjemedlemmar | Familjens dynamikSchweiz
-
Columbia UniversityNew York State Psychiatric InstituteAvslutadBarn utveckling | Interaktion mellan mor och spädbarn | Diabetes mellitus, graviditetFörenta staterna
-
Joslin Diabetes CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) och andra samarbetspartnersAvslutad
-
VA Office of Research and DevelopmentAktiv, inte rekryterandeDemens familjevårdare börda och konfliktFörenta staterna
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA); American Academy of Child Adolescent...AvslutadCoping färdigheter | FamiljerelationFörenta staterna