- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00577252
Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis
November 23, 2009 updated by: Akron Children's Hospital
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).
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Akron, Ohio, United States, 44308
- Akron Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adolescents age 13-19 with CF at a single CF center.
Description
Inclusion Criteria:
- cystic fibrosis age 13-19 yrs
Exclusion Criteria:
- acutely ill
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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1
Adolescents with CF.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Multiple measures of coping strategies in adolescents with cystic fibrosis.
Time Frame: Single visit
|
Single visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Coping startegies will be correlated with measures of clinical illness.
Time Frame: Single visit
|
Single visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathan C Kraynack, MD, Akron Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
December 18, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 20, 2007
Study Record Updates
Last Update Posted (Estimate)
November 24, 2009
Last Update Submitted That Met QC Criteria
November 23, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPING1424
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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