Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185549
Status:
COMPLETED
Last Update Posted:
2006-10-05
First Post:
2005-09-12
Brief Title:
An Interactive Program to Improve Care for Children With CF
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
An Interactive Program to Improve Care for Children With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2005-09
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:
The purpose of this study is to evaluate the impact of an internet based program for children and families CFDOC with Cystic Fibrosis on health outcomes The program provides for virtual visits a personal health record messaging with clinicians and several tools for monitoring self-care behaviors We anticipate that this intervention will provide for more intensive monitoring and feedback of self-care behaviors and will lead to improved health status and in particular nutritional status
Detailed Description:
Subjects will be drawn from the pool of children who receive their care at the LPCHStanford Cystic Fibrosis Center A letter will be sent to all eligible patients inviting them to participate in the study This letter will also be available in the CF clinic All subjects who agree to participate in the study will have the study described to them by a research assistant either in person or over the phone Informed consent will be obtained all on subjects Subject who elect to participate will be randomized into either an intervention group or a control group Subjects in the intervention group will be given Internet Access to the program CFDOC They will also be given training in how to use the program for communication with their clinicians participating in a virtual visit and using online forms and surveys Subjects in the control group will be advised that they will receive usual care and will have access to CFDOC at the completion of the study At the beginning of the study and at 3 month intervals subjects will be asked to complete a cystic fibrosis Quality of life survey At the beginning and end of the study all subjects will complete a patient experience questionnaire CAPHS 20 CCC supplement and an CFDOC evaluation survey As part of their regular care all subjects will also have their nutritional status measured and pulmonary function assessed subjects in the intervention group will asked to define treatment goals that are important to them eg attending camp or participating in sports and to define health measures that will help monitor progress in meeting these goals eg weekly weights or pulmonary function Subjects in the intervention group will be asked to log onto CFDOC at least one time per month
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