- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00273286
Family Management of Type 1 Diabetes in Children
11. Mai 2011 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
422
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Florida
-
Jacksonville, Florida, Vereinigte Staaten, 32207-8426
- Nemours Children's Clinic
-
-
Illinois
-
Chicago, Illinois, Vereinigte Staaten, 60614
- Children's Memorial Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Vereinigte Staaten, 02215
- Joslin Diabetes Center
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- Texas Children's Hospital
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
9 Jahre bis 14 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
glycemic control
Zeitfenster: 1/2006-3/2009
|
HbA1c
|
1/2006-3/2009
|
treatment adherence
Zeitfenster: 1/2006-3/2009
|
Diabetes Self Management Profile
|
1/2006-3/2009
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
quality of life
Zeitfenster: 1/2006-3/2009
|
PedsQL Diabetes
|
1/2006-3/2009
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Bruce Simons-Morton, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2006
Primärer Abschluss (Tatsächlich)
1. März 2009
Studienabschluss (Tatsächlich)
1. März 2009
Studienanmeldedaten
Zuerst eingereicht
5. Januar 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. Januar 2006
Zuerst gepostet (Schätzen)
9. Januar 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
13. Mai 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Mai 2011
Zuletzt verifiziert
1. April 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- FMOD
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Diabetes mellitus, Typ 1
-
SanofiAbgeschlossenDiabetes mellitus Typ 1 – Diabetes mellitus Typ 2Ungarn, Russische Föderation, Deutschland, Polen, Japan, Vereinigte Staaten, Finnland
-
Spiden AGDCB Research AGAbgeschlossenDiabetes mellitus Typ 1 | Diabetes mellitus Typ 1 mit Hypoglykämie | Diabetes mellitus Typ 1 mit HyperglykämieSchweiz
-
University of California, San FranciscoJuvenile Diabetes Research FoundationAbgeschlossenDiabetes mellitus Typ 1 | Diabetes mellitus, Typ I | Insulinabhängiger Diabetes mellitus 1 | Diabetes mellitus, insulinabhängig, 1 | IDDMVereinigte Staaten, Australien
-
Capillary Biomedical, Inc.BeendetDiabetes Typ 1 | Diabetes mellitus Typ 1 | Diabetes mellitus, Typ I | Diabetes mellitus, insulinabhängig, 1 | IDDMÖsterreich
-
Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute of Biocybernetics...UnbekanntDiabetes mellitus Typ 1 mit Hyperglykämie | Diabetes mellitus Typ 1 mit HypoglykämiePolen
-
Capillary Biomedical, Inc.AbgeschlossenDiabetes mellitus, Typ 1 | Diabetes Typ 1 | Diabetes mellitus Typ 1 | Diabetes mellitus, insulinabhängig, 1Australien
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)AbgeschlossenDiabetes mellitus Typ 1 | T1DM | T1D | Neu aufgetretener Diabetes mellitus Typ 1Vereinigte Staaten, Australien
-
Shanghai Changzheng HospitalRekrutierungSpröder Diabetes mellitus Typ 1China
-
AstraZenecaAbgeschlossenTyp 2 Diabetes mellitus | Diabetes mellitus Typ 1Vereinigte Staaten
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.AbgeschlossenDiabetes mellitus, Typ 1 | Diabetes Typ 1 | Diabetes Typ1 | Diabetes mellitus Typ 1 | Autoimmundiabetes | Diabetes mellitus, insulinabhängig | Jugenddiabetes | Diabetes, Autoimmun | Insulinabhängiger Diabetes mellitus 1 | Diabetes mellitus, insulinabhängig, 1 | Diabetes mellitus, spröde | Diabetes mellitus... und andere BedingungenVereinigte Staaten
Klinische Studien zur family diabetes management intervention
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Rekrutierung
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD)RekrutierungTyp 2 DiabetesVereinigte Staaten
-
Children's Hospital Medical Center, CincinnatiOffice of Head StartAbgeschlossenEntwicklungsverzögerungVereinigte Staaten
-
Columbia UniversityNew York State Psychiatric InstituteBeendetEntwicklung des Kindes | Mutter-Kind-Interaktion | Diabetes mellitus, SchwangerschaftVereinigte Staaten
-
VA Office of Research and DevelopmentAktiv, nicht rekrutierendBelastung und Konflikte für pflegende Angehörige bei DemenzVereinigte Staaten
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)AbgeschlossenOppositionelles Trotzverhalten | VerhaltensstörungKanada
-
Children's National Research InstituteNational Institute of Nursing Research (NINR); National Institutes of Health... und andere MitarbeiterAktiv, nicht rekrutierend
-
Northwell HealthAbgeschlossenPostpartale Depression | Verdacht auf nicht näher bezeichnete Kindesmisshandlung | Nicht näher bezeichnete Kindesmisshandlung, bestätigtVereinigte Staaten
-
Mental Health Services in the Capital Region, DenmarkTrygFonden, Denmark; Sektion for Tværsektoriel forskning - Region HovedstadenRekrutierungKind | Erziehung | Widerstandsfähigkeit | Psychische Störung | Verhütung | FamilieDänemark
-
Northern Jiangsu Province People's HospitalRekrutierungVorhofflimmern | TelemedizinChina