Evaluation of health-related quality of life impairment and associated factors in Japanese patients with chronic immune thrombocytopenia using patient-reported outcomes (EQUITY-J (Evaluating the QUality of life of patients with chronic Immune ThrombocYtopenia in Japan))
- Conditions
- chronic immune thrombocytopenia
- Registration Number
- jRCT1030240721
- Lead Sponsor
- Novartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 110
- Patients who provide written informed consent before study entry
- Male and female adult patients 18 years of age or older at the time of enrollment
- Patients with a documented physician diagnosis of ITP at least 1 year prior to the enrollment
- Patients who have been prescribed with the same drug(s) for the treatment of ITP for at least 3 months prior to the enrollment; patients with a decrease in the daily dose of medication during the 3 months are considered stable and therefore are eligible
- Number of platelets count within 3 months prior to the enrollment is available
- Past medical history is available; at least for 3 months prior to the enrollment at V1
- Patients with a documented physician diagnosis of secondary ITP prior to the enrollment
- Patients diagnosed with Evans syndrome or other forms of thrombocytopenia
- Patients with history of splenectomy; patients with history of partial splenic embolization are also considered ineligible
- Patients who have participated in any clinical trial for ITP within 3 months prior to the enrollment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SF-36 scores The scores of all the eight domains of SF-36 of Japanese patients with chronic ITP under continuous treatment with any pharmacotherapies for chronic ITP, in comparison to those of healthy Japanese subjects.
- Secondary Outcome Measures
Name Time Method Patient-reported outcomes questionnaires V1, the timing of enrollment The scores from patient-reported outcomes using the following questionnaires of patients with chronic ITP:
- Immune Thrombocytopenic Purpura Patient Assessment Questionnaire (ITP-PAQ)
- The ITP Life Quality Index (ILQI)
- EuroQoL-5Dimention-5Level (EQ-5D-5L)
- Work Productivity and Activity Impairment (WPAI)
- Patient Health Questionnaire-9 (PHQ-9)
- PRO measurement information system Short Form v1.0 Fatigue-13a (PROMIS SF v1.0 Fatigue-13a)
- Functional Assessment of Cancer Therapy - General item GP5 (FACT-GP5)Past medical history Prior to the enrollment Past medical history of patients with chronic ITP during the observation period (prior to the enrollment):
- HCRU-related parameters of patients with chronic ITP
- Number of outpatient visits (ITP-related and non-ITP related)
- Number of operative procedures (ITP-related and non-ITP related)
- Number of ER visit (ITP-related and non-ITP related)
- Number of hospitalization (ITP-related and non-ITP related; number and the length of stay [days per one hospitalization])
- Number of platelet transfusion
- Any pharmacotherapies (for ITP and not for ITP; daily dose and treatment duration of each medication)
- Number of serious bleeding symptoms (ITP-related)
- Blood test value (e.g., platelet count, hemoglobin, white blood count, red blood cell count)
- Duration of ITP since initial diagnosis