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

This study has been completed.
Sponsor:
Collaborator:
McMaster University
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00468949
First received: May 2, 2007
Last updated: July 27, 2011
Last verified: July 2011
  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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by McMaster University

Additional 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
Study First Received: May 2, 2007
Last Updated: July 27, 2011
Health Authority: Canada: Ethics Review Committee

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
Connective Tissue Diseases
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 24, 2014