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

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ClinicalTrials.gov Identifier: NCT00823914
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital

Brief 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.


Condition or disease
Psoriasis

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.


Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing A Validated Measure of the Impact of Psoriasis on Chronic Quality of Life
Study Start Date : December 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis




Primary Outcome Measures :
  1. Chronic Quality of Life (CQOL) survey validation. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Skin carotenoid levels [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alexandra Kimball, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00823914     History of Changes
Other Study ID Numbers: 2008P002090
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017

Keywords provided by Alexandra Kimball, Massachusetts General Hospital:
Psoriasis
Quality of Life

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases