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National Survey of People With Haemophilia in Portugal

Sponsor
University of Minho (Other)
Overall Status
Completed
CT.gov ID
NCT02870114
Collaborator
Hospital Sao Joao (Other), Portuguese hemophilia association and other congenital coagulopathies (Other)
146
Enrollment
1
Location
8.6
Duration (Months)
16.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    146 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Sociodemographic, Clinic and Psychosocial Aspects of People With Haemophilia in Portugal: a National Survey
    Study Start Date :
    Sep 1, 2016
    Actual Primary Completion Date :
    May 22, 2017
    Actual Study Completion Date :
    May 22, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Health Related Quality of Life in Adults as assessed by A36Hemofilia-Qol [1 year]

    2. 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

    3. 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).

    4. 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).

    5. 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

    1. Total score of Haemophilia-related functional limitations as assessed by Haemophilia Activities List (HAL) and Pediatric HAL [1 year]

    2. Anxiety score as assessed by PROMIS-Anxiety Short Form v1.0 [1 week]

      Assessmet of Anxiety

    3. Depression score as assessed by PROMIS-Depression Short Form v1.0 [1 week]

    4. Illness Perception as assessed by IPQ-R [1 year]

    5. Pain Catastrophizing as assessed by CSQ - Catastrophizing Subscale [1 year]

    6. Number of Joint Bleeds [1 year]

    7. Presence of inibitors [1 year]

    8. Number of target joints [1 year]

    9. Type of sports practiced by PWH [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Haemophilia A or B

    • Portuguese nationality

    Exclusion Criteria:

    • Acquired Haemophilia

    • Psychiatric or neurological deficit

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Life and Health Sciences Research Institute Braga Portugal 4710-057

    Sponsors and Collaborators

    • University of Minho
    • Hospital Sao Joao
    • Portuguese hemophilia association and other congenital coagulopathies

    Investigators

    • Principal Investigator: Patrícia R Pinto, PhD, Life and Health Sciences Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Patrícia Ribeiro Pinto, Post-doctoral fellow, University of Minho
    ClinicalTrials.gov Identifier:
    NCT02870114
    Other Study ID Numbers:
    • 520101.ID1825
    First Posted:
    Aug 17, 2016
    Last Update Posted:
    May 24, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Patrícia Ribeiro Pinto, Post-doctoral fellow, University of Minho
    Haemophilia
    Quality of Life
    Distress
    Hemarthrosis
    Pain
    Additional relevant MeSH terms:
    Hemophilia A

    Study Results

    No Results Posted as of May 24, 2017