CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 1,298 enrolled
Drug / intervention
Blood testingprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00340938
NCT00340938Phase 1Completed

Family Management of Childhood Diabetes Study

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·interventional·Posted Jun 21, 2006·Updated Dec 17, 2019

In Brief

A Phase 1 clinical trial evaluating Blood testing for Diabetes and Type 1 Diabetes. Completed, enrolled 1,298 participants across 3 sites.

Detailed 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 people's 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 family's 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 people's 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 14.5 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 child's 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 child's 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 21, 2006
Enrollment StartNov 8, 2004
Primary CompletionMar 1, 2009
Study CompletionAug 20, 2009
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.0 years ago

Interventions

Blood testingprocedure