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Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)

NCT01510873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 424

Last updated 2014-01-23

No results posted yet for this study

Summary

Symptoms of Primary Immune Thrombocytopenic Purpura (pITP), such as spontaneous bruising, menorrhagia, mucosal bleeding and other symptoms might significantly affect the HRQOL of pITP patients. However, very little evidence exists on HRQOL outcomes in patients diagnosed with pITP. The investigators project will aim at providing scientific community solid evidence based data on the extent to which HRQOL is compromised and in which specific area.

The purpose of this study is thus to compare generic Health-related Quality of Life (HRQOL) profiles of adult patients with primary Immune Thrombocytopenic Purpura (pITP) with that of a matched Italian population control Group.

Conditions

  • Immune Thrombocytopenic Purpura

Interventions

OTHER

HRQOL evaluation

Patients will be asked to complete a Questionnaire (i.e. HRQOL Survey Packet) that will cover a number of issues. These will include socio-demographic aspects, HRQOL information, symptom burden, clinical decision-making, social support and psychological wellbeing. Most of these information will be collected through well known psychometrically sound questionnaires. The copyright for using standardized questionnaires will be obtained, from the appropriate copyright holders, for the purpose of this research. The Questionnaire properly formatted will be distributed to all participating Centers prior to study start.

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Fabio Efficace, PhD · GIMEMA DATA CENTER, ROME, ITALY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01510873 on ClinicalTrials.gov