Cystic FibrosisPhase 2NCT01183286
CFfone: A Cell Phone Support Program for Adolescents With Cystic Fibrosis
A Phase 2 study testing CFFONE and CF website in people with Cystic Fibrosis, run by Dawkins Productions, Inc..
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… Read more about this study
- Who is it for?
- Ages 11 to 20 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- CFFONE and CF website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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) -
Who cannot join
- -Have a developmental disorder that would affect ability to respond to survey questions -
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- CFFONE, CF website
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFFONEBehavioural
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 websiteBehavioural
A CF-related educational website which has some areas of CF information and services relevant to adolescents.
| Study group | Role | What they receive |
|---|---|---|
| CFFONE | Active comparator | Not described Receives: Behavioral: CFFONE |
| CF website | Placebo comparator | Not described Receives: Behavioral: CF website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The CFK will be administered at baseline, month 3, month 6 and month 9.
Secondary outcomes (2)
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.
Measured: The CFQ-R will be administered at baseline, month 3, month 6 and month 9.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dawkins Productions, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, Columbia University, University of Tennessee, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183286
- Sponsor's protocol ID
- 5R44HL088826-03
- Status last verified
- Aug 2010
- First submitted
- 13 Aug 2010
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CFfone: A Cell Phone Support Program for Adolescents With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01183286
- Acronym / sponsor ID
- 5R44HL088826-03
- Conditions
- Cystic Fibrosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Dawkins Productions, Inc.University, hospital or other
- Collaborators
- University of Miami, Columbia University, University of Tennessee, Children's National Research Institute
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (estimated)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFFONE | Active comparator | Behavioral: CFFONE |
| CF website | Placebo comparator | Behavioral: CF website |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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) -
Key exclusion criteria (1 listed)
- -Have a developmental disorder that would affect ability to respond to survey questions -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CFFONEA 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. | Behavioural | CFFONE |
| CF websiteA CF-related educational website which has some areas of CF information and services relevant to adolescents. | Behavioural | CF website |
Primary outcome
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.
2 secondary outcomes
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2010.
Related trials for Cystic Fibrosis
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 2
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Not yet recruitingPhase 4
Iron Repletion in Cystic Fibrosis
Cystic Fibrosis, Iron Deficiencies
Recruiting
Diagnostic Value of Oropharyngeal Suction and Effect of Respiratory Physiotherapy on the Detection of Microorganisms in the Pediatric Patient
Cystic Fibrosis (CF), Bronchiectasis, Non-Cystic Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CFFONE and CF website in people with Cystic Fibrosis, run by Dawkins Productions, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystic Fibrosis Knowledge Questionnaire (CFK) (time frame: The CFK will be administered at baseline, month 3, month 6 and month 9.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2010; AzTrials last refreshed its copy on 31 Oct 2026.