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

Dupuytren's Contracture Clinical Trial

Official title:

Health-Related Quality of Life in Patients With Dupuytren's Disease: A Prospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00468949
• Other study ID #: 06-2713
• Status: Completed
• Phase: Phase 1
• First received: May 2, 2007
• Last updated: July 27, 2011
• Start date: May 2007
• Est. completion date: July 2011

Study information

• Verified date: July 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren's Contracture

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation	McMaster University

Country where clinical trial is conducted

Canada,