Developing A Validated Measure of the Impact of Psoriasis on Chronic Quality of Life
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Purpose
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.
| Condition |
|---|
|
Psoriasis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Developing A Validated Measure of the Impact of Psoriasis on Chronic Quality of Life |
- Chronic Quality of Life (CQOL) survey validation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Skin carotenoid levels [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Psoriasis patients aged 18 and older
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
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital CURTIS | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Alexa Kimball, MD, MPH | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Alexandra Kimball, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00823914 History of Changes |
| Other Study ID Numbers: | 2008P002090 |
| Study First Received: | January 14, 2009 |
| Last Updated: | May 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Psoriasis Quality of Life |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013