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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02870114
Other study ID # 520101.ID1825
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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