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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01988532

First Posted: November 20, 2013

Last Update Posted: January 18, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novo Nordisk A/S

Purpose

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.

Condition	Intervention
Congenital Bleeding Disorder Haemophilia A Haemophilia A With Inhibitors Haemophilia B Haemophilia B With Inhibitors	Other: No treatment given


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia

Resource links provided by NLM:

Genetics Home Reference related topics: hemophilia

Genetic and Rare Diseases Information Center resources: Hemophilia Hemophilia A Hemophilia B

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

Prevalence of acute (bleed-related) pain (percentage) [ Time Frame: At the first visit (only one study visit) ]
Prevalence of chronic (arthritic) pain (percentage) [ Time Frame: At the first visit (only one study visit) ]


Enrollment:	381
Study Start Date:	October 2013
Study Completion Date:	October 2014
Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Adult PWH	Other: No treatment given Subject will only fill out a questionnaire

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No
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.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988532

Locations


United States, New Jersey
Novo Nordisk Investigational Site
Plainsboro, New Jersey, United States, 08536

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Publications:

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

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


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01988532 History of Changes
Other Study ID Numbers:	HAEM-4073 U1111-1138-3464 ( Other Identifier: WHO )
First Submitted:	October 17, 2013
First Posted:	November 20, 2013
Last Update Posted:	January 18, 2017
Last Verified:	January 2017

Additional relevant MeSH terms:


Hemophilia A Hemophilia B Blood Coagulation Disorders Hemostatic Disorders Blood Coagulation Disorders, Inherited Hematologic Diseases	Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked Vascular Diseases Cardiovascular Diseases

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