National Survey of People With Haemophilia in Portugal

Haemophilia Clinical Trial

Official title:

Sociodemographic, Clinic and Psychosocial Aspects of People With Haemophilia in Portugal: a National Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870114
• Other study ID #: 520101.ID1825
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: May 23, 2017
• Start date: September 2016
• Est. completion date: May 22, 2017

Study information

• Verified date: May 2017
• Source: University of Minho
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a cross-sectional design investigation focused on the socio-demographic, clinical and psychosocial characterization of Portuguese people with haemophilia (PWH). All PWH, registered in the Portuguese Hemophilia Association (APH) will be identified in APH registries and contacted through mail, in order to be invited to participate in the first Portuguese survey on haemophilia. In case of acceptance, patients must sign the Informed Consent, fill in the questionnaires and send both back to the investigation team through a pre-paid envelope in the national mail system.

PWH of all ages are invited to participate in this survey. Adults (aged 18 and over) and children/youth from 10 to 17 will answer the questionnaires by self report. Parents of small children (0 to 9) will fill in the proxy versions. All questionnaires are adapted for the specific age groups.

This study will comply with ethic guidelines and was approved by the Life Sciences and Health Ethics Subcommittee (University of Minho) and is registered on the Portuguese authority for data collection (CNPD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 22, 2017
• Est. primary completion date: May 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Haemophilia A or B

• Portuguese nationality

Exclusion Criteria:

• Acquired Haemophilia

• Psychiatric or neurological deficit

Related Conditions & MeSH terms

• Haemophilia
• Hemophilia A

Locations

Country	Name	City	State
Portugal	Life and Health Sciences Research Institute	Braga

Sponsors (3)

Lead Sponsor	Collaborator
University of Minho	Hospital Sao Joao, Portuguese hemophilia association and other congenital coagulopathies

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol		1 year
Primary	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
Primary	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
Primary	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
Primary	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	Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL		1 year
Secondary	Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0	Assessmet of Anxiety	1 week
Secondary	Depression score as assessed by PROMIS-Depression Short Form v1.0		1 week
Secondary	Illness Perception as assessed by IPQ-R		1 year
Secondary	Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale		1 year
Secondary	Number of Joint Bleeds		1 year
Secondary	Presence of inibitors		1 year
Secondary	Number of target joints		1 year
Secondary	Type of sports practiced by PWH		1 year