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

NCT ID: NCT01988532

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

381 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adult PWH

No treatment given

Intervention Type OTHER

Subject will only fill out a questionnaire

Interventions

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No treatment given

Subject will only fill out a questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Plainsboro, New Jersey, United States

Site Status

Countries

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United States

References

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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

Reference Type 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

Reference Type RESULT

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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U1111-1138-3464

Identifier Type: OTHER

Identifier Source: secondary_id

HAEM-4073

Identifier Type: -

Identifier Source: org_study_id

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