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| Sponsored by: |
Hamilton Health Sciences |
|---|---|
| Information provided by: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT00468949 |
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.
| Study Type: | Observational |
| Study Design: | Longitudinal, Defined Population, Prospective Study |
| Official Title: | Health-Related Quality of Life in Patients With Dupuytren's Disease: A Prospective Cohort Study. |
| Estimated Enrollment: | 66 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | June 2008 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Achilleas Thoma, MD MSc FRCSC | 905-523-0019 | athoma@mcmaster.ca |
| Contact: Leslie McKnight, MSc | 905-522-1155 ext 35877 | mcknig@mcmaster.ca |
| Canada, Ontario | |
| St. Joseph's Healthcare | Recruiting |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Contact: Achilleas Thoma, MD MSc FRCSC 905-523-0019 athoma@mcmaster.ca | |
| Contact: Leslie McKnight, MSc 905-522-1155 ext 35877 mcknig@mcmaster.ca | |
| Principal Investigator: Achilleas Thoma, MD,MSC,FRCSC | |
| Principal Investigator: | Achilleas Thoma, MD MSC | St. Josephs Hamilton Health Care / McMaster University |
More Information
| Study ID Numbers: | 06-2713 |
| Study First Received: | May 2, 2007 |
| Last Updated: | July 31, 2007 |
| ClinicalTrials.gov Identifier: | NCT00468949 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Health-Related Quality of Life Dupuytren's Disease Health Utilities Index Short Form-36; Michigan Hand Outcomes Questionnaire |
|
Muscular Diseases Musculoskeletal Diseases Contracture Joint Diseases |
Connective Tissue Diseases Quality of Life Dupuytren's Contracture |
|
Muscular Diseases Musculoskeletal Diseases Contracture |
Joint Diseases Connective Tissue Diseases Dupuytren's Contracture |
