NCT01510873

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 424 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: The primary objective is to compare HRQOL of patients with pITP with that of a matched Italian population control Group. Secondary objectives include evaluation of: * Patient-reported fatigue amongst the three different pITP groups. * Social support and psychological wellbeing as a possible determinant of HRQOL. * Possible association between socio-demographic (e.g., age, living arrangements, education and employment status) and clinical variables (e.g., time from diagnosis, and current treatment if any) with patient reported health outcomes (e.g., HRQOL, fatigue, and social support). * To assess patients' preferences for involvement in treatment decision-making and the relationships between preferences and patient characteristics and to compare patient's stated preferences for involvement in treatment decision with the perceptions of their treating physicians (only for Newly Diagnosed pITP).

Conditions

• Immune Thrombocytopenic Purpura

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2012-01-18
• Last updated: 2014-01-23

Locations

29 sites across 1 country: Italy