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Health-Related Quality of Life in Patients With Dupuytren's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00468949
First Posted: May 3, 2007
Last Update Posted: July 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
McMaster University
Information provided by:
McMaster University
  Purpose

Main Research Questions:

We want to measure the change in quality of life in Dupuytren's disease patients who do and do not undergo surgery. Also, we want to test the validity of health related quality of life measurements in patients with Dupuytren's disease.

Why is this research important? Some patients with Dupuytren's contracture require excision surgery or palmar fasciectomy. Other patient's with Dupuytren's contracture do not require surgery; however, these patients may need surgery in the future. No studies have reported the health-related quality of life of patients with Dupuytren's disease whether related to surgical intervention or not.

What is being studied? We are studying the difference and change in health-related quality of life in patients suffering from Dupuytren's disease who require excision surgery and do not require surgery.


Condition Phase
Dupuytren's Contracture Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-Related Quality of Life in Patients With Dupuytren's Disease: A Prospective Cohort Study.

Resource links provided by NLM:


Further study details as provided by McMaster University:

Enrollment: 51
Study Start Date: May 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients undergoing excision surgery for their dupuytren's contracture
2
Patients not undergoing surgery for their excision surgery

Detailed Description:
Previous research on Dupuytren's disease has not reported the health-related quality of life (HRQL) of patients' whether related to surgical intervention or not. The primary objective of this study is to measure the change in HRQL in Dupuytren's contracture patients who do and do not undergo palmar fasciectomy. Health related quality of life will be measured using the 1) Health Utilities Index Mark III (HUI3); 2) Short Form-36 (SF-36); and the 3) Michigan Hand Outcomes Questionnaire (MHQ). The secondary objective is to look at the measurement properties, including the reliability and responsiveness, of each of the three HRQL instruments when they are used in patients with Dupuytren's contracture. We will also assess the concurrent validity of each of the HRQL instruments.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with dupuytren's contracture
Criteria

Inclusion Criteria:

  • patients who have the diagnosis of Dupuytren's disease
  • able to comprehend English to complete the self-reported questionnaires
  • willing to provide informed consent.

Exclusion Criteria:

  • patients who have had previous Dupuytren's contracture surgery on the same hand
  • patients who have carpal tunnel syndrome, rheumatoid arthritis, connective tissue disorder, tenosynovitis, or another condition that could affect quality of life
  • patients who are under the age of 18 years.
  Contacts and Locations
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): NCT00468949


Locations
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster University
Investigators
Principal Investigator: Achilleas Thoma, MD MSC St. Josephs Hamilton Health Care / McMaster University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Achilleas Thoma, McMaster University
ClinicalTrials.gov Identifier: NCT00468949     History of Changes
Other Study ID Numbers: 06-2713
First Submitted: May 2, 2007
First Posted: May 3, 2007
Last Update Posted: July 28, 2011
Last Verified: July 2011

Keywords provided by McMaster University:
Health-Related Quality of Life
Dupuytren's Disease
Health Utilities Index
Short Form-36;
Michigan Hand Outcomes Questionnaire

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases