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

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status: Completed

Conditions: Immune Thrombocytopenic Purpura

Treatments: Other: HRQOL evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT01510873

QoL-ITP0411

Details and patient eligibility

About

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.

Full 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).

Enrollment: 424 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A confirmed diagnosis of pITP in any phase of the disease;
• Patients aged at least 18 years;
• Informed consent provided

Exclusion criteria

• Participating in other HRQOL investigations that might interfere with this study
• Having any psychiatric condition or major cognitive impairment hampering self-reported HRQOL evaluation.

Trial design

424 participants in 3 patient groups

Newly Diagnosed pITP

Description:

Patients within 3 months from diagnosis.

Treatment:

Other: HRQOL evaluation

Persistent pITP

Description:

Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy.

Treatment:

Other: HRQOL evaluation

Chronic pITP

Description:

Patients with ITP lasting for more than 12 months.

Treatment:

Other: HRQOL evaluation