National Survey of People With Haemophilia in Portugal

May 23, 2017 updated by: Patrícia Ribeiro Pinto, University of Minho

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Braga, Portugal, 4710-057
        • Life and Health Sciences Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Haemophilia A or B
  • Portuguese nationality

Exclusion Criteria:

  • Acquired Haemophilia
  • Psychiatric or neurological deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol
Time Frame: 1 year
1 year
Health Related Quality of Life in Children as assessed by Canadian Haemophilia Outcomes-Kids Life Assessment Tool
Time Frame: 1 year
Health Related Quality of Life in Children
1 year
Pain Intensity
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL
Time Frame: 1 year
1 year
Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0
Time Frame: 1 week
Assessmet of Anxiety
1 week
Depression score as assessed by PROMIS-Depression Short Form v1.0
Time Frame: 1 week
1 week
Illness Perception as assessed by IPQ-R
Time Frame: 1 year
1 year
Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale
Time Frame: 1 year
1 year
Number of Joint Bleeds
Time Frame: 1 year
1 year
Presence of inibitors
Time Frame: 1 year
1 year
Number of target joints
Time Frame: 1 year
1 year
Type of sports practiced by PWH
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Collaborators

Hospital Sao Joao
Portuguese hemophilia association and other congenital coagulopathies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ACTUAL)

May 22, 2017

Study Completion (ACTUAL)

May 22, 2017

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (ESTIMATE)

August 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 520101.ID1825

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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