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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00823914
First received: January 14, 2009
Last updated: June 25, 2013
Last verified: June 2013
  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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Chronic Quality of Life (CQOL) survey validation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Psoriasis patients aged 18 and older

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823914

Locations
United States, Massachusetts
Massachusetts General Hospital CURTIS
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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: June 25, 2013
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 April 21, 2014