Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273286
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2006-01-05
Brief Title:
Family Management of Type 1 Diabetes in Children
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Family Management of Childhood Diabetes Study
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None