Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Coping Compliance and Adjustment in Adolescents With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577252
• Other study ID #: COPING1424
• Secondary ID: COPING1424
• Status: Completed
• Phase: N/A
• First received: December 18, 2007
• Last updated: November 23, 2009
• Start date: October 2007
• Est. completion date: April 2008

Study information

• Verified date: November 2009
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• cystic fibrosis age 13-19 yrs

Exclusion Criteria:

• acutely ill

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple measures of coping strategies in adolescents with cystic fibrosis.		Single visit	No
Secondary	Coping startegies will be correlated with measures of clinical illness.		Single visit	No