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

January 17, 2017 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

381

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult PWH
Other: No treatment given
Subject will only fill out a questionnaire

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

November 13, 2013

First Posted (Estimate)

November 20, 2013

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 17, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAEM-4073
  • U1111-1138-3464 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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