CFfone: A Cell Phone Support Program for Adolescents With Cystic Fibrosis
1 other identifier
interventional
146
0 countries
N/A
Brief Summary
Adolescents with cystic fibrosis are particularly vulnerable to poor adherence, which negatively impacts their health status, quality of life and long term survival. CFFONE: A Cell Phone Support Program for Adolescents with Cystic Fibrosis, will make use of cutting-edge technology- a broadband capable, cellular telephone keyed into a highly-interactive informational web site. This web site will provide engaging online learning activities and resources specific to adolescents with cystic fibrosis. We believe the information and activities contained in CFFONE will improve adolescents knowledge, attitudes, and practices around cystic fibrosis and that adolescents exposed to the CFFONE program will demonstrate an increase in adherence to their treatment regimens and related improvements in their health status and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2010
CompletedFirst Posted
Study publicly available on registry
August 17, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedAugust 17, 2010
August 1, 2010
1.6 years
August 13, 2010
August 16, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Cystic Fibrosis Knowledge Questionnaire (CFK)
The CFK assess participants' CF-related knowledge. The CFK consists of 42 multiple-choice items, with scores reported as percentage correct.
The CFK will be administered at baseline, month 3, month 6 and month 9.
Secondary Outcomes (2)
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
The CFQ-R will be administered at baseline, month 3, month 6 and month 9.
Pharmacy Refill Data
Pharmacy Refill Data will be collected at baseline for the 12 months prior to enrollment; and again after the 9 month clinic visit for the 9 months of the study. The Prescribed Treatment Plan will be collected at baseline, month 3, month 6 and month 9.
Study Arms (2)
CFFONE
ACTIVE COMPARATORCF website
PLACEBO COMPARATORInterventions
A password-protected, secure website, which can be accessed via a web capable cell phone. The website contains age appropriate medical and behavioral information, disease management tools and social networking features for adolescents and young people who have Cystic Fibrosis.
A CF-related educational website which has some areas of CF information and services relevant to adolescents.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of Cystic Fibrosis
- Be within the target age range of 11-20 years old at enrollment -Have regular access to an internet connected computer that does not prevent access to websites (i.e. a firewall) -
You may not qualify if:
- Have a developmental disorder that would affect ability to respond to survey questions -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dawkins Productions, Inc.lead
- University of Miamicollaborator
- Columbia Universitycollaborator
- University of Tennesseecollaborator
- Children's National Research Institutecollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 13, 2010
First Posted
August 17, 2010
Study Start
September 1, 2010
Primary Completion
April 1, 2012
Last Updated
August 17, 2010
Record last verified: 2010-08