Overview

This trial is active, not recruiting.

Conditions al amyloidosis, amyloidosis
Treatment non-interventional
Sponsor Prothena Therapeutics Ltd.
Collaborator Amyloidosis Research Consortium
Start date October 2015
End date December 2016
Trial size 343 participants
Trial identifier NCT02574676, CO-083252

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective prospective

Primary Outcomes

Measure
Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis
time frame: Change from Baseline to 12 months

Secondary Outcomes

Measure
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
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients must have AL Amyloidosis Exclusion Criteria:

Additional Information

Official title Prospective Observational Study Measuring the Short-Form36 ( SF-36v2) and Other QOL Tools in an AL Amyloidosis Population
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Prothena Therapeutics Ltd..