National Survey of People With Haemophilia in Portugal

NCT02870114 | Completed

• 1 other identifier: 520101.ID1825
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to implement a national survey to collect information regarding Portuguese people with haemophilia (PWH) on socio-demographic, clinical and psychosocial factors.

Conditions

Haemophilia

Keywords

Haemophilia; Quality of Life; Distress; Hemarthrosis; Pain

Outcome Measures

Primary Outcomes (5)

• Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol

  1 year

• Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool

  Health Related Quality of Life in Children

  1 year

• Pain Intensity

  Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).

  1 year

• Pain Location

  Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).

  1 year

• Pain Duration

  Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).

  1 year

Secondary Outcomes (9)

• Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL

  1 year

• Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0

  1 week

• Depression score as assessed by PROMIS-Depression Short Form v1.0

  1 week

• Illness Perception as assessed by IPQ-R

  1 year

• Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale

  1 year

Eligibility Criteria

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

Study Population

People with Haemophilia A or B, of any age and gender, registered in the Portuguese Haemophilia Association

You may qualify if:

• Haemophilia A or B
• Portuguese nationality

You may not qualify if:

• Acquired Haemophilia
• Psychiatric or neurological deficit

Sponsors & Collaborators

• University of Minho: lead
• Hospital Sao Joao: collaborator
• Portuguese hemophilia association and other congenital coagulopathies: collaborator

Study Sites (1)

Life and Health Sciences Research Institute

Braga, 4710-057, Portugal

Location

MeSH Terms

Conditions

Hemophilia A; Hemarthrosis; Pain

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; Joint Diseases; Musculoskeletal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Patrícia R Pinto, PhD

  Life and Health Sciences Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral fellow

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 17, 2016
• Study Start: September 1, 2016
• Primary Completion: May 22, 2017
• Study Completion: May 22, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)