- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01183286
CFfone: A Cell Phone Support Program for Adolescents With Cystic Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
Placebo Comparator: CF website
|
A CF-related educational website which has some areas of CF information and services relevant to adolescents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cystic Fibrosis Knowledge Questionnaire (CFK)
Time Frame: The CFK will be administered at baseline, month 3, month 6 and month 9.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time Frame: The CFQ-R will be administered at baseline, month 3, month 6 and month 9.
|
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.
|
Pharmacy Refill Data
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R44HL088826-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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