Health-related Quality of Life and Fatigue in Adult Patients With Primary Immune Thrombocytopenic Purpura (pITP)
1 other identifier
observational
424
1 country
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2011
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 12, 2012
CompletedFirst Posted
Study publicly available on registry
January 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJanuary 23, 2014
January 1, 2014
2.1 years
January 12, 2012
January 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of HRQOL of patients with pITP with that of a matched Italian population control Group.
By the end of the study.
Secondary Outcomes (4)
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.
Study Arms (3)
Newly Diagnosed pITP
Patients within 3 months from diagnosis.
Persistent pITP
Patients between 3 to 12 months from diagnosis; includes patients not reaching spontaneous remission or not maintaining complete response off therapy.
Chronic pITP
Patients with ITP lasting for more than 12 months.
Interventions
Patients will be asked to complete a Questionnaire (i.e. HRQOL Survey Packet) that will cover a number of issues. These will include socio-demographic aspects, HRQOL information, symptom burden, clinical decision-making, social support and psychological wellbeing. Most of these information will be collected through well known psychometrically sound questionnaires. The copyright for using standardized questionnaires will be obtained, from the appropriate copyright holders, for the purpose of this research. The Questionnaire properly formatted will be distributed to all participating Centers prior to study start.
Eligibility Criteria
Adult patients (18 years of age or older) with confirmed diagnosis of pITP in any phase of the disease
You may qualify if:
- A confirmed diagnosis of pITP in any phase of the disease;
- Patients aged at least 18 years;
- Informed consent provided
You may not qualify if:
- Participating in other HRQOL investigations that might interfere with this study
- Having any psychiatric condition or major cognitive impairment hampering self-reported HRQOL evaluation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Ospedale Generale Regionale "F. Miulli"
Acquaviva delle Fonti, Italy
Azienda Ospedaliero-Universitaria Policlinico Consorziale
Bari, Italy
Azienda Sanitaria Locale BA - Ospedale di Venere
Bari, Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy
Ospedale Binaghi
Cagliari, Italy
Ospedale Businco
Cagliari, Italy
U.O.C. di Onco-Ematologia - Centro di Ricerca e Formazione ad Alta tecnologia nelle Scienze Biomediche
Campobasso, Italy
US Dipartimentale - Centro per le malattie del sangue - Ospedale Civile - S.Giacomo
Castelfranco Veneto, Italy
Azienda Ospedaliero Universitaria
Foggia, Italy
Azienda Ospedaliera Universitaria San Martino
Genova, Italy
DIMI- Clinica Ematologica - Università degli studi di Genova
Genova, Italy
Ospedale Santa Maria Goretti
Latina, Italy
Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
Messina, Italy
Azienda Ospedaliera Universitaria - Policlinico "G. Martino"
Messina, Italy
Azienda Ospedaliero - Universitaria di Modena
Modena, Italy
Azienda Ospedaliera "S. Gerardo dei Tintori"
Monza, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy
Ospedale S. Luigi Gonzaga
Orbassano, Italy
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone
Palermo, Italy
Azienda Ospedaliero - Universitaria di Parma
Parma, Italy
Azienda Ospedaliera "Bianchi - Melacrino - Morelli"
Reggio Calabria, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
U.O.S.A. Ematologia ASL RMA Presidio Nuovo Regina Margherita
Roma, Italy
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Rome, Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, Italy
Azienda Ospedaliero - Universitaria "San Giovanni Battista"
Torino, Italy
Azienda Ospedaliera
Treviglio, Italy
ULSS N.6 Ospedale San Bortolo
Vicenza, Italy
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabio Efficace, PhD
GIMEMA DATA CENTER, ROME, ITALY
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2012
First Posted
January 18, 2012
Study Start
December 1, 2011
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
January 23, 2014
Record last verified: 2014-01