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Evaluation of HRQoL in Adult With Immune Thrombocytopenia in China (HRQoL)

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ClinicalTrials.gov Identifier: NCT03324087
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Qilu Hospital of Shandong University (Qingdao)
Jining Medical University
Liaocheng People's Hospital
Yantai Yuhuangding Hospital
Binzhou Medical University
Weifang People's Hospital
Linyi People's Hospital
Shengli Oilfield Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
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.

Condition or disease Intervention/treatment
Immune Thrombocytopenia Diagnostic Test: HRQoL

Detailed Description:

Immune thrombocytopenia (ITP) is an autoimmune thrombocytopenic syndrome characterized by decreased platelet count and an increased risk of bleeding.The pathogenesis of ITP has been considered as autoantibody-mediated and cell-mediated platelet over-destruction. The estimated prevalence for ITP in the China is 5-10/100,000. Adult women are disproportionately affected by the disorder, with a female to male ratio of nearly two to one. The disorder rarely remits spontaneously in adult subjects. The mortality rate is relatively low (< 1%) in adults less than 65 years of age. Morbidity increases above age 65, primarily as a result of an increase in age-related major bleeding events.

The decision to treat and the type of treatment are controversial, since among the different medications available, none has proven its superiority regarding reduction in bleeding complications or transition to chronic ITP. Furthermore, profound thrombocytopenia, the risk of intracranial bleeding, and the appearance of bruises may seriously influence lifestyle, school functioning and physical activities and frequently result in anxiety in children and adults. Therefore, since the benefit-risk ratio of current medications is unclear and as the psychological and the physical burden of the disease is highly variable, it appears necessary to develop new tools to better understand the exact impact of the disease on daily life. Although treatment decision making depends essentially on the physician's experience, it seems of interest to include in this reflection a measurement of quality of life. In this context, evaluation of health 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. In addition, subjects who are resistant to current therapies are likely to experience an even greater decrement to their HRQoL than responders to treatment. Thus, restoring and/or maintaining quality of life should be an important goal of treatment.

HRQoL can be analyzed by universal or disease specific scales, the latter usually have better reactivity. 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. The ITP Participants 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. The reliability and validity of these scales have been confirmed by a number of studies at home and abroad.

Therefore, the investigators conducted a real-world multicenter study using SF-36 and ITP-PAQ questionnaires to assess the HRQoL in participants with ITP in the real world, and analyze the influencing factors of HRQoL so as to provide a sufficient basis for clinical decision making.


Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Center Prospective Study of Evaluating Health Related Quality of Life in Adult With Immune Thrombocytopenia in China Using Real-world Data
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018


Group/Cohort Intervention/treatment
Adult patients with ITP
The investigators are undertaking a multi-center, prospective trail of 1000 adult ITP patients and use 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.
Diagnostic Test: HRQoL
use 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.




Primary Outcome Measures :
  1. ITP-PAQ [ Time Frame: From date of randomization until the date of first documented progression,up to 12 months ]
    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.

  2. SF-36 [ Time Frame: From date of randomization until the date of first documented progression,up to 12 months ]
    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.


Secondary Outcome Measures :
  1. bleeding score [ Time Frame: From date of randomization until the date of first documented progression,up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
From January 2016 to December 2018, ITP patients aged above 14 years will be enrolled in this study. They will be recruited in ten hospitals of Shandong province, China. Patients were eligible if they can finish the questionares correctly by themselves. Patients were excluded if they have any concomitant disease that could impact their quality of life significantly.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324087


Contacts
Contact: Ming Hou +86-18560087007 houming@medmail.com.cn

Locations
China, Shandong
Shandong University Qilu hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou       qlhouming@sina.com   
Sponsors and Collaborators
Shandong University
Qilu Hospital of Shandong University (Qingdao)
Jining Medical University
Liaocheng People's Hospital
Yantai Yuhuangding Hospital
Binzhou Medical University
Weifang People's Hospital
Linyi People's Hospital
Shengli Oilfield Hospital
Investigators
Principal Investigator: Ming Hou Qilu hospital, Shandong University

Publications:
Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT03324087     History of Changes
Other Study ID Numbers: ITP-HRQoL
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ming Hou, Shandong University:
HRQoL
Immune Thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms