Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT00577252
First received: December 18, 2007
Last updated: November 23, 2009
Last verified: November 2009
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis

Resource links provided by NLM:


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 ]

Estimated Enrollment: 40
Study Start Date: October 2007
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577252

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

No publications provided

Responsible Party: Nathan Kraynack, MD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00577252     History of Changes
Other Study ID Numbers: COPING1424, COPING1424
Study First Received: December 18, 2007
Last Updated: November 23, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014