CFfone: A Cell Phone Support Program for Adolescents With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

CFfone: A Cell Phone Support Program for Adolescents With Cystic Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01183286
• Other study ID #: 5R44HL088826-03
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 13, 2010
• Last updated: August 16, 2010
• Start date: September 2010

Study information

• Verified date: August 2010
• Source: Dawkins Productions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Generations of patients with cystic fibrosis (CF) have spent their childhoods fighting for breath and losing. Until recently, CF patients succumbed to this fatal, inherited lung disease as infants, young children or adolescents. With cutting-edge research spurring medical advances, each decade has shown improved survival, from a median life expectancy of 5 years in 1960, to 16 years in 1970, to 35 years today. Yet, the disease remains complex and adolescents with CF experience challenges that can reduce their adherence to treatment regimens and undermine their long-term well-being.

Poor adherence to complicated life long treatments impacts a patient's health and burdens the medical system. Adolescents are particularly vulnerable to poor adherence and its high costs. Even adolescents who experience comparatively mild symptoms of CF must follow a 3-hour treatment regimen every day, and medical experts report that their adherence ranges from poor (50% doing less than prescribed airway clearance regimen) to very poor (30% not doing any prescribed treatments).

CF can cause a host of social-emotional stressors, including uncertainty about the future, poor self-image, low self-esteem, and frustration with delayed growth/maturation all of which can impede adherence. Absences from school, being teased, keeping their illness secret, and lack of access to peers with CF due to risk of infection leave many adolescents with CF feeling isolated and alone. Due to parent over-protection and medical services that focus on symptoms, these patients often lack supportive coaching on issues (e.g., alcohol-and tobacco-related risks, sexual health, infection control, pain control, career prospects) that can impact the quality of their life.

This Phase II Randomized Control Trial (study) will test the hypothesis that adolescents with cystic fibrosis (CF) ages 11-17 (adolescent participants) and young adults with CF, ages 18-20 (adult participants) who access a password-protected, secure mobile website (CFFONE), via a web capable cell phone and use the site's age appropriate medical and behavioral information, disease management tools and social networking features will demonstrate: (1) an increase in CF knowledge- the primary end point of the study; (2) improved treatment adherence and improved quality of life- the secondary end points of the study and; (3) enhanced social support- the exploratory end point of the study, when compared to control group adolescent participants and adult participants.

To test this hypothesis, a longitudinal experimental design will be carried out in which participants will be randomly assigned to one of two conditions: cell phone access to CFFONE; or registering with a CF-related educational website containing CF information and services relevant to adolescents.

A recent National Institutes for Health solicitation for research to improve self-management and quality of life in children and adolescents with chronic diseases stated that, "Children with a chronic disease face a lifetime of careful health management requirements and lifestyle adaptations to prevent or manage related health complications. Interventions that make a difference in childhood disease self-management may set the stage for health outcomes later in life." (2003) We believe that CFFONE, with its innovative approach for enhancing self-management, has the potential to make that kind of difference in the lives of adolescents with cystic fibrosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 20 Years

Eligibility

Inclusion Criteria:

• 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) -

Exclusion Criteria:

-Have a developmental disorder that would affect ability to respond to survey questions -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• CFFONE
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.
• CF website
A CF-related educational website which has some areas of CF information and services relevant to adolescents.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Dawkins Productions, Inc.	Children's Research Institute, Columbia University, University of Miami, University of Tennessee

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Cystic Fibrosis Questionnaire-Revised (CFQ-R)	To assess participants' quality of life the CFQ-R will be taken to measure the impact of CF on the participant's social functioning, respiratory symptoms and treatment burden. These three domains consist of 13 items. The adolescent/adult version will be used for participants 15-20 and the CFQ-R Older Child version will be used for participants ages 11-14.	The CFQ-R will be administered at baseline, month 3, month 6 and month 9.	No
Secondary	Pharmacy Refill Data	To measure treatment adherence a print out of CF related medications and refill data will be collected from participants' pharmacies. To obtain participant's prescription information in order to have adherence calculations for three month periods, the attending physician will fill out a prescribed treatment plan at every clinic visit during the study	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.	No