Clinical Trial: Quality of Life (QOL) Registry for Patients With AL Amyloidosis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

Official Title: Prospective Observational Study Measuring the Short-Form36 ( SF-36v2) and Other QOL Tools in an AL Amyloidosis Population

Brief Summary: This is an online registry to document the psychometric properties of SF-36v2 among patients with AL Amyloidosis, to document patients' burden of disease, to better understand the patient's experience and to follow quality of life issues using a variety of QOL measures.

Detailed Summary:
Sponsor: Prothena Therapeutics Ltd.

Current Primary Outcome: Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis [ Time Frame: Change from Baseline to 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Calculate burden of illness from participants using SF-36 Mental Component Score (MCS) and Physical Component Score (PCS) compared with sample from US general population and three other chronic conditions: Congestive Heart Failure, Lymphoma and COPD [ Time Frame: Baseline- cross sectional ]
    The comparison is made to other populations from the baseline cross-sectional measurements. There is no timeframe, except baseline
  • Assess the pathway to diagnosis and treatment through a disease history specific questionnaire collecting organ involvement, initial symptoms, diagnosis duration, treatment received and other disease characteristics [ Time Frame: Baseline- cross sectional ]
    The analysis is done atbaseline .
  • Psychometric evaluation of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in patients with AL Amyloidosis [ Time Frame: Change from Baseline to 12 months ]
  • Psychometric evaluation of Patient Global Impression-Severity Scale (PGI-S) in patients with AL Amyloidosis [ Time Frame: Change from Baseline to 12 months ]
  • Psychometric evaluation of Patient Global Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis [ Time Frame: Change from Baseline to 12 months ]
  • Psychometric evaluation of Hematology Patient Reported Symptom Screen (HPRSS) in patients with AL Amyloidosis [ Time Frame: Change from Baseline to 12 months ]
  • Psychometric evaluation of Work Productivity and Activity Questionnaire: Specific Health Problem V2.0 (WPAI:SHP) in patients with AL Amyloidosis [ Time Frame: Change from Baseline to 12 months ]
  • Psychometric evaluation of MOS 6-Item Sleep Scale Standard in patients with AL Amyloidosis [ Time Frame: Change from Baseline to 12 months ]


Original Secondary Outcome: Same as current

Information By: Prothena Therapeutics Ltd.

Dates:
Date Received: October 5, 2015
Date Started: October 2015
Date Completion: December 2016
Last Updated: September 26, 2016
Last Verified: September 2016