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

Overview

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.

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 2018

Interventions

  • Other: non-interventional

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients must have AL Amyloidosis Exclusion Criteria:

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prothena Biosciences Ltd.
  • Collaborator
    • Amyloidosis Research Consortium
  • Provider of Information About this Clinical Study
    • Sponsor

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