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

April 7, 2019 updated by: Prothena Biosciences Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

343

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • South San Francisco, California, United States, 94080
        • Online registry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with Al Amyloidosis

Description

Inclusion Criteria:

  • Patients must have AL Amyloidosis

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The comparison is made to other populations from the baseline cross-sectional measurements. There is no timeframe, except baseline
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
The analysis is done atbaseline .
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
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
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
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
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
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
Change from Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prothena Biosciences Ltd.

Collaborators

Amyloidosis Research Consortium
Amyloidosis Support Groups
Amyloidosis Foundation
Quality Metrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

October 5, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 7, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CO-083252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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