Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 424
- Locations
- 29
- Primary Endpoint
- Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
Study Overview
Brief 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).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
Time Frame: By the end of the study.
Secondary Outcomes
- Patient-reported fatigue amongst the three different pITP groups(By the end of the study.)
- Patient-reported fatigue amongst the three different pITP groups.(By the end of the study.)
- Possible association between socio-demographic and clinical variables with patient reported health outcomes.(By the end of the study.)
- To assess patients' preferences for involvement in treatment decision-making.(By the end of the study.)