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An Interactive Program to Improve Care for Children With CF

This study has been completed.
Information provided by:
Stanford University Identifier:
First received: September 12, 2005
Last updated: October 4, 2006
Last verified: September 2005
The purpose of this study is to evaluate the impact of an internet based program for children and families (CF.DOC) 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

Condition Intervention
Cystic Fibrosis Behavioral: CF. DOC

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: An Interactive Program to Improve Care for Children With Cystic Fibrosis

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Improvement in nutritional status
  • Improvement in CF related quality of life

Secondary Outcome Measures:
  • Phone utilization
  • COmponents of program liked and dis-liked

Estimated Enrollment: 60
Study Start Date: March 2004
Estimated Study Completion Date: September 2005
Detailed Description:
Subjects will be drawn from the pool of children who receive their care at the LPCH/Stanford 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 CF.DOC. 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 CF.DOC 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 2.0 CCC supplement ) and an CF.DOC 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 (e.g. attending camp or participating in sports) and to define health measures that will help monitor progress in meeting these goals e.g. weekly weights or pulmonary function. Subjects in the intervention group will be asked to log onto CF.DOC at least one time per month.

Ages Eligible for Study:   1 Month to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Patients with Cystic Fibrosis diagnosed by a sweat chloride analysis and/or testing for the CF gene between the ages of 1 month and 21 years of age. Patients must also be English speaking -

Exclusion Criteria: Non-English speaking patients

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00185549

United States, California
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Principal Investigator: David A Bergman, MD Stanford University
  More Information Identifier: NCT00185549     History of Changes
Other Study ID Numbers: 78910
Study First Received: September 12, 2005
Last Updated: October 4, 2006

Keywords provided by Stanford University:
Cystic Fibrosis;
patient education,

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on September 21, 2017