Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

NCT01988532 | Completed

• 2 other identifiers: HAEM-4073U1111-1138-3464
• Study Type: observational
• Target: 381
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia A With Inhibitors; Haemophilia B; Haemophilia B With Inhibitors

Outcome Measures

Primary Outcomes (2)

• Prevalence of acute (bleed-related) pain (percentage)

  At the first visit (only one study visit)

• Prevalence of chronic (arthritic) pain (percentage)

  At the first visit (only one study visit)

Study Arms (1)

Adult PWH

Other: No treatment given

Interventions

No treatment given OTHER

Subject will only fill out a questionnaire

Adult PWH

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult PWH in the United States of America (USA) willing to consent to participation who have any history of joint bleeding or joint pain presenting for a comprehensive care visit during which joint range of motion will be assessed.

You may qualify if:

• 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)

You may not qualify if:

• Previous participation in this study

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Plainsboro, New Jersey, 08536, United States

Location

Related Publications (2)

• 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 Hemophilia (PWH). 14th WFH International Musculoskeletal Congress 2015; : Abstract number: P-224 Country: Northern Ireland City: Belfast

  RESULT

• 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) Study. 14th WFH International Musculoskeletal Congress 2015; : Abstract number: MP-209 Country: Northen Ireland City: Belfast

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: November 20, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)