Quality of Life (QOL) Registry for Patients With AL Amyloidosis
Prospective Observational Study Measuring the Short-Form36 ( SF-36v2) and Other QOL Tools in an AL Amyloidosis Population
1 other identifier
observational
343
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedApril 9, 2019
April 1, 2019
2.8 years
October 5, 2015
April 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis
Change from Baseline to 12 months
Secondary Outcomes (8)
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
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
Psychometric evaluation of Kansas City Cardiomyopathy Questionnaire (KCCQ-12) 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
Psychometric evaluation of Patient Global Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis
Change from Baseline to 12 months
- +3 more secondary outcomes
Interventions
Eligibility Criteria
Patients with Al Amyloidosis
You may qualify if:
- Patients must have AL Amyloidosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prothena Biosciences Ltd.lead
- Amyloidosis Research Consortiumcollaborator
- Amyloidosis Support Groupscollaborator
- Amyloidosis Foundationcollaborator
- Quality Metricscollaborator
Study Sites (1)
Online registry
South San Francisco, California, 94080, United States
Related Publications (1)
Bayliss M, McCausland KL, Guthrie SD, White MK. The burden of amyloid light chain amyloidosis on health-related quality of life. Orphanet J Rare Dis. 2017 Jan 19;12(1):15. doi: 10.1186/s13023-016-0564-2.
PMID: 28103898DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 14, 2015
Study Start
October 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
April 9, 2019
Record last verified: 2019-04