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NCT02574676 Clinical Trial

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

Amyloidosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02574676
Other study ID # CO-083252
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date July 2018

Study information
Verified date April 2019
Source Prothena Therapeutics Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 343
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have AL Amyloidosis

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• non-interventional

Locations
Country Name City State
United States Online registry South San Francisco California

Sponsors (5)
Lead Sponsor Collaborator
Prothena Therapeutics Ltd. Amyloidosis Foundation, Amyloidosis Research Consortium, Amyloidosis Support Groups, Quality Metrics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis Change from Baseline to 12 months
Secondary 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 The comparison is made to other populations from the baseline cross-sectional measurements. There is no timeframe, except baseline Baseline- cross sectional
Secondary 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 The analysis is done atbaseline . Baseline- cross sectional
Secondary Psychometric evaluation of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in patients with AL Amyloidosis Change from Baseline to 12 months
Secondary Psychometric evaluation of Patient Global Impression-Severity Scale (PGI-S) in patients with AL Amyloidosis Change from Baseline to 12 months
Secondary Psychometric evaluation of Patient Global Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis Change from Baseline to 12 months
Secondary Psychometric evaluation of Hematology Patient Reported Symptom Screen (HPRSS) in patients with AL Amyloidosis Change from Baseline to 12 months
Secondary 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
Secondary Psychometric evaluation of MOS 6-Item Sleep Scale Standard in patients with AL Amyloidosis Change from Baseline to 12 months
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