Cystic FibrosisNCT00577252
Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Akron Children's Hospital at 1 site in United States.
Trial summary
In this research, we will use established surveys to look at the relationship between various styles of coping with a disease, religious coping styles, treatment compliance, locus of control, broad measures of mental health and adjustment, and basic health data (e.g., PFTs, recent hospitalizations or antibiotics… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2008
- Phase
- Observational
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Adolescents age 13-19 with CF at a single CF center.
Who may be able to join
- cystic fibrosis age 13-19 yrs
Who cannot join
- acutely ill
Trial locations and contacts
1 site in 1 country.
About this study
In this research, we will use established surveys to look at the relationship between various styles of coping with a disease, religious coping styles, treatment compliance, locus of control, broad measures of mental health and adjustment, and basic health data (e.g., PFTs, recent hospitalizations or antibiotics within the past year, lung microbiology, CFTR mutations, and co-morbid conditions such as diabetes, depression, and liver disease). While the research is correlational, it should suggest relationships (both positive and negative) between various coping styles and desired outcomes (compliance and well-being).
Read the detailed description
OVERVIEW: We anticipate that the data we collect will help us better understand some of the factors associated with improved coping, treatment compliance, and emotional adjustment, which, in turn, may suggest possible interventions to improve compliance, emotional adjustment, and general physical health. Specific hypotheses include the following:
- Subjects who score high on measures of positive coping will have greater levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of negative coping will have lower levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of positive religious coping will have greater levels of treatment compliance and psychological well being.
- Subjects who score high on measures of negative religious coping will have lower levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of internal locus of control will have higher levels of treatment compliance and psychological well-being compared to subjects who score low on measures of internal locus of control.
- Subjects who score high on measures of treatment compliance will have higher levels of physical health.
- We do not anticipate a positive correlation between positive coping mechanisms and general physical health; however, subjects who score high on measures of negative coping may have lower levels of general physical health (e.g., lower PFTs, increased rates and lengths of hospitalizations) probably due to third variables (e.g., if someone uses denial as a coping mechanism, it may lead to poor treatment compliance, which may lead to declines in physical health).
- Anecdotal evidence suggests that parental education may be positively correlated with treatment compliance, but this has not been evaluated. Likewise, anecdotal evidence suggest that marital status may be correlated with treatment compliance (probably because of third variables, e.g., if, as much research suggests, divorce is related to lower SES and fewer social supports, these factors may in turn interfere with treatment compliance). Two questions on the demographic sheet will allow us to explore whether or not this may be worth exploring further.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Adolescents, Coping Compliance, Adjustment
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adolescents with CF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple measures of coping strategies in adolescents with cystic fibrosis.
Measured: Single visit
Secondary outcomes (1)
Coping startegies will be correlated with measures of clinical illness.
Measured: Single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startOct 2007
- Study completionApr 2008
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Nathan C Kraynack, MD, Principal investigator, Akron Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577252
- Sponsor's protocol ID
- COPING1424
- Other IDs
- COPING1424
- Status last verified
- Nov 2009
- First submitted
- 18 Dec 2007
- Last updated
- 24 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00577252
- Acronym / sponsor ID
- COPING1424
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Adolescents, Coping Compliance, Adjustment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Apr 2008 (actual)
- First posted
- 20 Dec 2007 (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.
In this research, we will use established surveys to look at the relationship between various styles of coping with a disease, religious coping styles, treatment compliance, locus of control, broad measures of mental health and adjustment, and basic health data (e.g., PFTs, recent hospitalizations or antibiotics within the past year, lung microbiology, CFTR mutations, and co-morbid conditions such as diabetes, depression, and liver disease). While the research is correlational, it should suggest relationships (both positive and negative) between various coping styles and desired outcomes (compliance and well-being).
Detailed description
OVERVIEW: We anticipate that the data we collect will help us better understand some of the factors associated with improved coping, treatment compliance, and emotional adjustment, which, in turn, may suggest possible interventions to improve compliance, emotional adjustment, and general physical health. Specific hypotheses include the following:
- Subjects who score high on measures of positive coping will have greater levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of negative coping will have lower levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of positive religious coping will have greater levels of treatment compliance and psychological well being.
- Subjects who score high on measures of negative religious coping will have lower levels of treatment compliance and psychological well-being.
- Subjects who score high on measures of internal locus of control will have higher levels of treatment compliance and psychological well-being compared to subjects who score low on measures of internal locus of control.
- Subjects who score high on measures of treatment compliance will have higher levels of physical health.
- We do not anticipate a positive correlation between positive coping mechanisms and general physical health; however, subjects who score high on measures of negative coping may have lower levels of general physical health (e.g., lower PFTs, increased rates and lengths of hospitalizations) probably due to third variables (e.g., if someone uses denial as a coping mechanism, it may lead to poor treatment compliance, which may lead to declines in physical health).
- Anecdotal evidence suggests that parental education may be positively correlated with treatment compliance, but this has not been evaluated. Likewise, anecdotal evidence suggest that marital status may be correlated with treatment compliance (probably because of third variables, e.g., if, as much research suggests, divorce is related to lower SES and fewer social supports, these factors may in turn interfere with treatment compliance). Two questions on the demographic sheet will allow us to explore whether or not this may be worth exploring further.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adolescents with CF. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Adolescents age 13-19 with CF at a single CF center.
Key inclusion criteria (1 listed)
- cystic fibrosis age 13-19 yrs
Key exclusion criteria (1 listed)
- acutely ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Multiple measures of coping strategies in adolescents with cystic fibrosis.
Time frame: Single visit
1 secondary outcome
Coping startegies will be correlated with measures of clinical illness.
Time frame: Single visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2009.
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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.
Nathan C Kraynack, MD principal investigator
Akron Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Akron Children's Hospital at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 24 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Multiple measures of coping strategies in adolescents with cystic fibrosis. (time frame: Single visit). 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 24 Nov 2009.