Clinical trial NCT02870114: National Survey of People With Haemophilia in Portugal
Official title: Sociodemographic, Clinic and Psychosocial Aspects of People With Haemophilia in Portugal: a National Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemophilia
Keywords: Haemophilia
Quality of Life
Distress
Hemarthrosis
Pain
Lead sponsor: University of Minho
Sponsor class: OTHER
Collaborators: name: Hospital Sao Joao
name: Portuguese hemophilia association and other congenital coagulopathies
First posted: 2016-08-17
Enrollment: 146
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with Haemophilia A or B, of any age and gender, registered in the Portuguese Haemophilia Association

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).

Eligibility criteria: Inclusion Criteria:

* Haemophilia A or B
* Portuguese nationality

Exclusion Criteria:

* Acquired Haemophilia
* Psychiatric or neurological deficit

Primary outcomes:
measure: Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol
timeFrame: 1 year
measure: Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool
timeFrame: 1 year
measure: Pain Intensity
timeFrame: 1 year
measure: Pain Location
timeFrame: 1 year
measure: Pain Duration
timeFrame: 1 year
Secondary outcomes:
measure: Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL
timeFrame: 1 year
measure: Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0
timeFrame: 1 week
measure: Depression score as assessed by PROMIS-Depression Short Form v1.0
timeFrame: 1 week
measure: Illness Perception as assessed by IPQ-R
timeFrame: 1 year
measure: Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale
timeFrame: 1 year
measure: Number of Joint Bleeds
timeFrame: 1 year
measure: Presence of inibitors
timeFrame: 1 year
measure: Number of target joints
timeFrame: 1 year
measure: Type of sports practiced by PWH
timeFrame: 1 year
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Life and Health Sciences Research Institute
Study officials:
affiliation: Life and Health Sciences Research Institute
name: Patrícia R Pinto, PhD
role: PRINCIPAL_INVESTIGATOR
References: