Developing A Validated Measure of the Impact of Psoriasis on Chronic Quality of Life

Psoriasis Clinical Trial

Official title:

Developing A Validated Measure of the Impact of Psoriasis on Chronic Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823914
• Other study ID #: 2008P002090
• Status: Completed
• Phase: N/A
• First received: January 14, 2009
• Last updated: March 23, 2017
• Start date: December 2008
• Est. completion date: December 2013

Study information

• Verified date: March 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective of the study is to create and validate Chronic Quality of Life (CQOL) index that explores habits, career paths and other life choices psoriasis patients make as a result of coping with their disease that may not be impacted by therapy implemented at a given point in time.

• The investigators think this data will show that patients who were diagnosed at a young age will have worse chronic quality of life.

Description:

As a visible disease, psoriasis can be embarrassing and psychosocially stressful in addition to physically uncomfortable. Patients' lives are affected in physical, psychological, social, sexual and occupational aspects. These burdens may cause patients to assume maladaptive habits and coping mechanisms, leading to a downward spiral in functioning within society, prohibiting patients from achieving their highest potential quality of life.

The investigators' study goal is to create and validate Chronic Quality of Life (CQOL) index that explores habits, career paths and other life choices psoriasis patients make as a result of coping with their disease that may not be impacted by therapy implemented at a given point in time. In creating this questionnaire and validating it the investigators will collect preliminary data. The investigators think this data will show that patients who were diagnosed at a young age will have worse chronic quality of life. In the long run, the investigators will use the CQOL index in studies in which patients are treated for psoriasis to determine which treatments can change a psoriasis patient's chronic quality of life. This information will be used to create guidelines for treatment focused on achieving a patient's optimal quality of life.

Another aspect that the investigators would like to look at is the skin carotenoid levels in the psoriasis population. Previous studies showed that psoriasis patients had lower levels of skin carotenoids when compared to healthy volunteers. This observation was not statistically significant perhaps due to a small sample size (21 subjects in the psoriasis group and 35 subjects in the control group). Skin carotenoid levels measurement is optional for study subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to understand and sign informed consent

• Able to read English

• Able to comply with study procedure

• Male or female of at least 18 years of age

• Has a diagnosis of psoriasis

Exclusion Criteria:

• Has any medical condition that might interfere with ability to complete CQOL survey

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital CURTIS	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Quality of Life (CQOL) survey validation.		1 year
Secondary	Skin carotenoid levels		1 year