National Survey of People With Haemophilia in Portugal

Completed

• Conditions: Haemophilia

• Registration Number: NCT02870114
• Lead Sponsor: University of Minho

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.

Detailed 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).

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-17
• Study Start: 2016-09
• Status Verified: 2017-05
• Primary Completion: 2017-05-22
• Study Completion: 2017-05-22
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Haemophilia A or B
• Portuguese nationality

Exclusion Criteria

• Acquired Haemophilia
• Psychiatric or neurological deficit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool	1 year	Health Related Quality of Life in Children
Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol	1 year
Pain Location	1 year	Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Pain Intensity	1 year	Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).
Pain Duration	1 year	Pain Questionnaire developed specifically for this investigation to assess PWH (based on Wallny's Pain Questionnaire for PWH and Brief Pain Inventory).

Secondary Outcome Measures

Name	Time	Method
Presence of inibitors	1 year
Illness Perception as assessed by IPQ-R	1 year
Number of Joint Bleeds	1 year
Number of target joints	1 year
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	Assessmet of Anxiety
Type of sports practiced by PWH	1 year
Depression score as assessed by PROMIS-Depression Short Form v1.0	1 week
Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale	1 year

Trial Locations

Locations (1)

Life and Health Sciences Research Institute; 🇵🇹 Braga, Portugal