Congenital Bleeding Disorder Clinical Trial
Official title:
Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia
| Verified date | January 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study is conducted in the United States of America (USA). The aim of the study is to assess the impact of pain on functional impairment and quality of life in adult persons with hemophilia (PWH) with and without inhibitors with joint bleeding.
| Status | Completed |
| Enrollment | 381 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Adult males able to provide consent and complete a survey in English - Congenital hemophilia A or B with or without inhibitors with any history of joint bleeding or joint pain - Presentation at the treatment center for a comprehensive annual visit where joint range of motion will be obtained - Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol) Exclusion Criteria: - Previous participation in this study |
| Country | Name | City | State |
|---|---|---|---|
| United States | Novo Nordisk Investigational Site | Plainsboro | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
United States,
Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Wang M., Buckner T., Cooper D. Functional Impairment, Pain, and Pain Management in Adult People with Haemophilia (PWH): Initial Lessons from the Pain Functional Impairment and Quality of Life (P-FIQ
Wang M., Baumann K., Akins S., Funk S., Hernandez G., Kempton C., Buckner T., Cooper D. Pain, Functional Impairment, and Quality of Life (P-FIQ): Reliability of Patient-Reported Outcome (PRO) Instruments Assessing Pain and Function in US Adult People With
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of acute (bleed-related) pain (percentage) | At the first visit (only one study visit) | ||
| Primary | Prevalence of chronic (arthritic) pain (percentage) | At the first visit (only one study visit) |
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