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Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis
This study is currently recruiting participants.
Verified by Akron Children's Hospital, December 2007
Sponsored by: Akron Children's Hospital
Information provided by: Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00577252
  Purpose

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).


Condition
Cystic Fibrosis

Genetics Home Reference related topics: cystic fibrosis
MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Cross-Sectional
Official Title: Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis

Further study details as provided by Akron Children's Hospital:

Primary Outcome Measures:
  • Multiple measures of coping strategies in adolescents with cystic fibrosis. [ Time Frame: Single visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coping startegies will be correlated with measures of clinical illness. [ Time Frame: Single visit ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: April 2008
Groups/Cohorts
1
Adolescents with CF.

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:

  1. Subjects who score high on measures of positive coping will have greater levels of treatment compliance and psychological well-being.
  2. Subjects who score high on measures of negative coping will have lower levels of treatment compliance and psychological well-being.
  3. Subjects who score high on measures of positive religious coping will have greater levels of treatment compliance and psychological well being.
  4. Subjects who score high on measures of negative religious coping will have lower levels of treatment compliance and psychological well-being.
  5. 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.
  6. Subjects who score high on measures of treatment compliance will have higher levels of physical health.
  7. 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).
  8. 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.
  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adolescents age 13-19 with CF at a single CF center.

Criteria

Inclusion Criteria:

  • cystic fibrosis age 13-19 yrs

Exclusion Criteria:

  • acutely ill
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577252

Contacts
Contact: Nathan C Kraynack, MD 3305433249 nkraynack@chmca.org
Contact: Deborah Ouellette, RNC 3305433249 douellette@chmca.org

Locations
United States, Ohio
Akron Children's Hospital Recruiting
Akron, Ohio, United States, 44308
Principal Investigator: Nathan Kraynack, MD            
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Nathan C Kraynack, MD Akron Children's Hospital
  More Information

Responsible Party: Akron Children's Hospital ( Nathan Kraynack, MD )
Study ID Numbers: COPING1424, COPING1424
Study First Received: December 18, 2007
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00577252  
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
Cystic fibrosis
Adolescents
Coping Compliance
Adjustment

Study placed in the following topic categories:
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009