AL Amyloidosis, Amyloidosis
Conditions
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.
Interventions
OTHERnon-interventional
Sponsors
Amyloidosis Support Groups
Amyloidosis Research Consortium
Amyloidosis Foundation
Quality Metrics
Prothena Biosciences Ltd.
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have AL Amyloidosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychometric evaluation of short-form 36 (SF-36v2) in patients with AL Amyloidosis | Change from Baseline to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | — |
| 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 Hematology Patient Reported Symptom Screen (HPRSS) in patients with AL Amyloidosis | 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 | 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 Assessment of Functioning (GAF) Scale in patients with AL Amyloidosis | Change from Baseline to 12 months | — |
Countries
United States
Outcome results
None listed