Immune Thrombocytopenia Clinical Trial
— HRQoLOfficial title:
A Multi-Center Prospective Study of Evaluating Health Related Quality of Life in Adult With Immune Thrombocytopenia in China Using Real-world Data
Immune thrombocytopenia (ITP) is a heterogeneous disorder with variable clinical symptomsHealth related quality of life (HRQoL) could be considered in ITP, as in numerous chronic diseases, as a method to provide information about the effects of medical interventions. Symptoms of ITP, such as spontaneous bruising, menorrhagia, mucosal bleeding and prolonged bleeding with injury, may significantly affect HRQoL in ITP subjects. Treatments for chronic ITP can also be associated with substantial side effects. Restoring and/or maintaining quality of life should be an important goal of treatment. We conducted a real-world multicenter study using SF-36 and ITP-PAQ questionnaires to assess the HRQoL in patients with ITP in the real world, and analyze the influencing factors of HRQoL so as to provide a sufficient basis for clinical decision making.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Meet the diagnostic criteria for immune thrombocytopenia. 2. aged of 14-80 years. 3. Need or do not need treatments. Exclusion Criteria: 1. Patients have any concomitant disease that could impact their quality of life significantly such as mental disorders 2. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 3. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. 4. Patients who are deemed unsuitable for the study by the investigator. |
Country | Name | City | State |
---|---|---|---|
China | Shandong University Qilu hospital | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University | Binzhou Medical University, Jining Medical University, Liaocheng People's Hospital, Linyi People's Hospital, Qilu Hospital of Shandong University (Qingdao), Shengli Oilfield Hospital, Weifang People's Hospital, Yantai Yuhuangding Hospital |
China,
Efficace F, Mandelli F, Fazi P, Santoro C, Gaidano G, Cottone F, Borchiellini A, Carpenedo M, Simula MP, Di Giacomo V, Bergamaschi M, Vincelli ID, Rodeghiero F, Ruggeri M, Scaramucci L, Rambaldi A, Cascavilla N, Forghieri F, Petrungaro A, Ditonno P, Caocci G, Cirrincione S, Mazzucconi MG. Health-related quality of life and burden of fatigue in patients with primary immune thrombocytopenia by phase of disease. Am J Hematol. 2016 Oct;91(10):995-1001. doi: 10.1002/ajh.24463. Epub 2016 Jul 14. — View Citation
Flores A, Klaassen RJ, Buchanan GR, Neunert CE. Patterns and influences in health-related quality of life in children with immune thrombocytopenia: A study from the Dallas ITP Cohort. Pediatr Blood Cancer. 2017 Aug;64(8). doi: 10.1002/pbc.26405. Epub 2017 Jan 23. — View Citation
Grace RF, Neunert C. Second-line therapies in immune thrombocytopenia. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):698-706. Review. — View Citation
Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17. Review. — View Citation
Mathias SD, Li X, Eisen M, Carpenter N, Crosby RD, Blanchette VS. A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Romiplostim on Health-Related Quality of Life in Children with Primary Immune Thrombocytopenia and Associated Burden in Their Parents. Pediatr Blood Cancer. 2016 Jul;63(7):1232-7. doi: 10.1002/pbc.25984. Epub 2016 Apr 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ITP-PAQ | ITP Patient Assessment Questionnaire (ITP-PAQ) was developed to assess disease-specific quality of life (QoL) in adults with ITP. It is a 44-item questionnaire that includes scales for physical health (symptoms, fatigue/sleep, bother, and activity), emotional health (psychological and fear), overall QoL, social activity, women's reproductive health, and work. | From date of randomization until the date of first documented progression,up to 12 months | |
Primary | SF-36 | Medical Outcomes Study Short Form 36 Health Survey (SF-36) is one of the most widely used universal HRQoL scales, and it is widely used in the HRQoL measurement of general population, evaluation of clinical trials and health policy evaluation. | From date of randomization until the date of first documented progression,up to 12 months | |
Secondary | bleeding score | From date of randomization until the date of first documented progression,up to 12 months |
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