Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340938
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Brief Title:
Family Management of Childhood Diabetes Study
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Family Management of Childhood Diabetes Study
Status:
COMPLETED
Status Verified Date:
2019-11-01
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 study will test the effectiveness of a practical low-cost problem-solving method called WE CAN that can be taught to families at diabetes clinics The goal is to see if this teaching and support can help with controlling the level of blood sugar in children with type 1 diabetes as they approach adolescence Attention would go to young peoples completion of tasks necessary to manage diabetes quality of life and psychological adjustments plus the role of the family in these situations Type 1 diabetes mellitus accounting for less than 10 of the disease cases is marked by the inability of the pancreas to secrete insulin People who have it must consistently manage their disease Successful disease management for children depends on the familys adaptation to treatment demands Yet maintaining acceptable blood sugar control becomes more difficult for adolescents owing to changes in the body during that period of life Also early adolescence is a vital time in peoples development of health outcomes The title WE CAN is a way to remember the steps of the problem-solving method
Work together to set goals
Explore barriers and solutions
Choose the best solutions
Act on your plan
Note the results
Children who have reached age 9 but are not yet 145 years who have had type 1 diabetes for at least 1 year and who have had at least two visits to diabetes clinics at one of four clinical sites may be eligible for this study A total of 120 children will participate in clinic visits once every 3 months
Participants and their families will attend diabetes clinic visits once every 3 months They will be assigned to one of two groups standard care or WE CAN Those in the WE CAN group will have visits about 15 to 45 minutes longer than those involved in the standard care group All participants will have two home visits at the beginning and at 6 months There will also be telephone interviews about 20 minutes long once every 3 months with the children and their parents Medical data will be collected during each visit to the clinic including blood samples A health advisor will work with the families Questionnaires given to parents and children separately will measure diabetes-related family conflict parent child sharing of responsibilities for the disease attitudes and emotions about diabetes and impact of the disease on the childs life Also parents and children together will take part in a 10-minute discussion of a diabetes-related issue that has caused friction among family members They will discuss the problem come up with possible solutions and to try to decide on a solution within 10 minutes Family discussions will be videotaped at the first home visit and at the 6-month home visit
Families in both groups will receive more detailed monitoring of family diabetes management than is usually the case Those in the WE CAN group may be able to control diabetes more effectively during the childs early adolescence though that result is not guaranteed If the family guidance and support provided by the WE CAN health advisor is effective children in that group may have better results in blood sugar than they would if they did not participate in the study Each family member completing the first and 6-month visits and completing each telephone interview will receive payment for participating
Work together to set goals
Explore barriers and solutions
Choose the best solutions
Act on your plan
Note the results
Children who have reached age 9 but are not yet 145 years who have had type 1 diabetes for at least 1 year and who have had at least two visits to diabetes clinics at one of four clinical sites may be eligible for this study A total of 120 children will participate in clinic visits once every 3 months
Participants and their families will attend diabetes clinic visits once every 3 months They will be assigned to one of two groups standard care or WE CAN Those in the WE CAN group will have visits about 15 to 45 minutes longer than those involved in the standard care group All participants will have two home visits at the beginning and at 6 months There will also be telephone interviews about 20 minutes long once every 3 months with the children and their parents Medical data will be collected during each visit to the clinic including blood samples A health advisor will work with the families Questionnaires given to parents and children separately will measure diabetes-related family conflict parent child sharing of responsibilities for the disease attitudes and emotions about diabetes and impact of the disease on the childs life Also parents and children together will take part in a 10-minute discussion of a diabetes-related issue that has caused friction among family members They will discuss the problem come up with possible solutions and to try to decide on a solution within 10 minutes Family discussions will be videotaped at the first home visit and at the 6-month home visit
Families in both groups will receive more detailed monitoring of family diabetes management than is usually the case Those in the WE CAN group may be able to control diabetes more effectively during the childs early adolescence though that result is not guaranteed If the family guidance and support provided by the WE CAN health advisor is effective children in that group may have better results in blood sugar than they would if they did not participate in the study Each family member completing the first and 6-month visits and completing each telephone interview will receive payment for participating
Detailed Description:
This protocol describes 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
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-CH-N030 | None | None | None |