Ignite Creation Date:
2024-05-06 @ 4:01 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02432586
Status:
COMPLETED
Last Update Posted:
2017-06-23
First Post:
2015-03-10
Brief Title:
Pilot Study Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Pilot Study Intensive Education in a Residential Camp Setting for Families of Young Children With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2017-06
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:
TotCamp
Brief Summary:
18 preschool aged children and their families will attend structured multidisciplinary family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children A second booster session will be conducted 6 months later
Detailed Description:
We propose to deliver a structured multidisciplinary family-centered intervention over a 3-day weekend with a second similar booster session 6 months later The intervention will be based at our regional diabetes camp Camp Sweeney The proposed camp encounters aim to provide
An opportunity for intensive education beyond that achievable in a single class and without the unfavorable impacts of multiple weekday classes on family and work time
Varied educational modalities including didactic sessions practical demonstrations and role playing
Close observation of each child throughout the day and night by experienced diabetes counselors and medical staff to identify and help correct maladaptive family behaviors
A safe environment where parents can participate in group therapy sessions without child care worries
An opportunity for age-appropriate child-centered educational and therapeutic activities
An opportunity for families to form mutually-supportive friendships
Fun weekends away where the parents have help caring for their diabetic children
We will conduct this pilot study which will enroll 18 preschool children age 3-55 years with the goal of obtaining preliminary results for 15 subjects
The primary outcome to be determined approximately one month before and after each of the two camp sessions is improvement in Hemoglobin A1c HbA1c This outcome will be compared with that of historical controls
Exploratory Hypotheses
Compared with pretreatment baseline and historical controls subjects attending two 3-day sessions at a family diabetes camp will improve
HbA1c 3 months after the first camp session
Hypoglycemia frequency as measured by continuous glucose monitoring
Medical system utilization as measured by telephone call frequency and also by emergency room visits and hospitalizations
BehavioralQoL assessments including the parents of young children version of the hypoglycemia fear survey HFS-P-YC the Behavioral Pediatrics Feeding Assessment Scale BPFAS and the general and diabetes modules of the PedsQL
Diabetes knowledge assessed by questionnaire
Development of friendships between subject families assessed by questionnaire
An opportunity for intensive education beyond that achievable in a single class and without the unfavorable impacts of multiple weekday classes on family and work time
Varied educational modalities including didactic sessions practical demonstrations and role playing
Close observation of each child throughout the day and night by experienced diabetes counselors and medical staff to identify and help correct maladaptive family behaviors
A safe environment where parents can participate in group therapy sessions without child care worries
An opportunity for age-appropriate child-centered educational and therapeutic activities
An opportunity for families to form mutually-supportive friendships
Fun weekends away where the parents have help caring for their diabetic children
We will conduct this pilot study which will enroll 18 preschool children age 3-55 years with the goal of obtaining preliminary results for 15 subjects
The primary outcome to be determined approximately one month before and after each of the two camp sessions is improvement in Hemoglobin A1c HbA1c This outcome will be compared with that of historical controls
Exploratory Hypotheses
Compared with pretreatment baseline and historical controls subjects attending two 3-day sessions at a family diabetes camp will improve
HbA1c 3 months after the first camp session
Hypoglycemia frequency as measured by continuous glucose monitoring
Medical system utilization as measured by telephone call frequency and also by emergency room visits and hospitalizations
BehavioralQoL assessments including the parents of young children version of the hypoglycemia fear survey HFS-P-YC the Behavioral Pediatrics Feeding Assessment Scale BPFAS and the general and diabetes modules of the PedsQL
Diabetes knowledge assessed by questionnaire
Development of friendships between subject families assessed by questionnaire
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