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

Completed

• Conditions: Amyloidosis; AL Amyloidosis

• Registration Number: NCT02574676
• Lead Sponsor: Prothena Biosciences Ltd.

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 Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-14
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 343

Inclusion Criteria

• Patients must have AL Amyloidosis

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Psychometric evaluation of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in patients with AL Amyloidosis	Change from Baseline to 12 months
Psychometric evaluation of Hematology Patient Reported Symptom Screen (HPRSS) in patients with AL Amyloidosis	Change from Baseline to 12 months
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	Baseline- cross sectional	The comparison is made to other populations from the baseline cross-sectional measurements. There is no timeframe, except baseline
Psychometric evaluation of Patient Global Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis	Change from Baseline to 12 months
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	Baseline- cross sectional	The analysis is done atbaseline .
Psychometric evaluation of Work Productivity and Activity Questionnaire: Specific Health Problem V2.0 (WPAI:SHP) in patients with AL Amyloidosis	Change from Baseline to 12 months
Psychometric evaluation of MOS 6-Item Sleep Scale Standard in patients with AL Amyloidosis	Change from Baseline to 12 months
Psychometric evaluation of Patient Global Impression-Severity Scale (PGI-S) in patients with AL Amyloidosis	Change from Baseline to 12 months

Trial Locations

Locations (1)

Online registry; 🇺🇸 South San Francisco, California, United States