Evaluation of HRQoL in Adult With Immune Thrombocytopenia in China

NCT03324087 | Unknown DMC

• 1 other identifier: ITP-HRQoL
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Keywords

HRQoL; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• bleeding score

  From date of randomization until the date of first documented progression,up to 12 months

Study Arms (1)

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

Interventions

HRQoL DIAGNOSTIC_TEST

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.

Adult patients with ITP

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Meet the diagnostic criteria for immune thrombocytopenia.
• aged of 14-80 years.
• Need or do not need treatments.

You may not qualify if:

• Patients have any concomitant disease that could impact their quality of life significantly such as mental disorders
• 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)
• 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.
• Patients who are deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Shandong University: lead
• Qilu Hospital of Shandong University (Qingdao): collaborator
• Jining Medical University: collaborator
• Liaocheng People's Hospital: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Binzhou Medical University: collaborator
• Weifang People's Hospital: collaborator
• Linyi People's Hospital: collaborator
• Shengli Oilfield Hospital: collaborator

Study Sites (1)

Shandong University Qilu hospital

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 28416506 BACKGROUND

• Grace RF, Neunert C. Second-line therapies in immune thrombocytopenia. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;2016(1):698-706. doi: 10.1182/asheducation-2016.1.698.

  PMID: 27913549 BACKGROUND

• 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.

  PMID: 28111877 BACKGROUND

• 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.

  PMID: 27351715 BACKGROUND

• 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.

  PMID: 27037553 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Ming Hou

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou

CONTACT

+86-18560087007; houming@medmail.com.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: October 27, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 27, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)