Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01974830 |
| Other study ID # |
CT-10-04 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2013 |
| Est. completion date |
September 6, 2019 |
Study information
| Verified date |
September 2019 |
| Source |
Coram Clinical Trials |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
This is a longitudinal, observational, non-interventional registry study, designed to collect
both retrospective and prospective real world data, on patients receiving Alpha-1
augmentation therapy in the home through Coram Specialty Infusion.The data will be collected
from standard Coram homecare forms, as well as patient reported case forms.
Description:
This is a longitudinal, observational, non-interventional registry study, designed to collect
both retrospective and prospective data, in order to acquire real-world data on product
prescribing, product use by patients, and product performance for patients receiving α1-PI
therapy in a homecare and/or a Coram ambulatory infusion suite. There is no limit on the
number of subjects that may participate in the registry. The AL1TER Registry will be overseen
by the Principal Investigator listed on the first page of this protocol. No less than 40
physicians in the US will participate in this registry; there will be no upper limit to this
number. All patients ≥18 years old, not members of a vulnerable study population, and who
require α1-PI therapy may be invited to participate in this study.
Participation in the AL1TER Registry will continue as long as the subject is:
Being treated with α1-PI therapy using Coram's infusion services, Using an insurance carrier
for which Coram is an approved provider, Willing to participate in this registry, and Until
the Sponsor, Principal Investigator or subject decides to terminate their participation.
The data collection for this study differs from other registries in that data going into the
AL1TER Registry is being collected by homecare agency personnel (i.e., pharmacists and
nurses). The data will be collected from standard Coram homecare forms. AL1TER Registry data
will be entered into Coram's standard patient database and processed in the same manner as
for non-registry patients but will be extracted in a systematic fashion for incorporation
into the AL1TER Registry. Data collected from the St. George Respiratory Questionnaire
(SGRQ), and the Life Quality index Questionnaire (LQIQ), and subject medical chart review may
also be entered into the AL1TER Registry database. All data will be de-identified for use
when reporting results of the database.
All subjects participating in the AL1TER Registry will be informed about the Registry by the
submitting investigators, or their designee. Additionally with physician permission, registry
staff can contact patients via mail and phone to consent, only after patients have been
accepted on Coram's service and agreed to start therapy. Collection of subject data for
incorporation into the AL1TER Registry will begin only after the subject signs the informed
consent form.
In addition to the standard visit/data collection already carried out by Coram, subjects will
also be asked to complete two short quality of life questionnaires every six months beginning
with 30 days after the date subject signs informed consent.
This registry study will continue until such time as the sponsor, Coram Clinical Trials,
makes the decision to terminate data collection. At such time all submitting investigators,
subjects and the IRB will be notified of study termination. Subject participation will begin
from the date they sign informed consent and will continue until the sponsor, Principal
Investigator, submitting investigator, or subject decides to terminate their participation or
the registry itself is terminated. The authorization by a subject for use of their Protected
Health Information (PHI) for the AL1TER Registry has no expiration date.
The AL1TER Registry involves compilation of the standard data collected for all patients
receiving α1-PI therapy within the Coram system; data collected from the SGRQ and LQIQI, and
relevant items from patient medical history, including pulmonary function tests. Since the
registry is both retrospective and prospective, forms from the start of the patients care,
through to the end of their care will be made available for entry into the registry, even
forms that predate the signing of the ICF. Sample forms of the standard data collected for
Coram patients are included in the appendices. The information that is captured for each
α1-PI patient using Coram's standard forms may include:
Patient Start of Care:
Patient information (contact, date of birth, height, weight, gender, tobacco/alcohol/drug
use) Age at time of development of symptoms, and age at time of diagnosis Medical/surgical
history Alpha-1 Genotype Baseline FEV1 value Therapy and safety review (diagnosis, therapy,
administration method, PICC length, date of insertion, etc.) Care plan
Ongoing Patient Assessment:
Patient information Changes in dosing Infections/illness Antibiotic use Primary care
physician visits Emergency room visits Hospitalizations Effects from infusions Other changes
in health Care plan update(s) Clinical monitoring (lab values, weight, nutrition screen, FEV1
values.)
Home Visit Assessments:
Patient information Therapy information Medical history and medications (initial and ongoing)
Vital signs/weight Patient/home safety Access device for infusion therapy Nursing
interventions Assessments: respiratory, cardiovascular, gastrointestinal, genitourinary,
musculoskeletal, neurosensory, integumentary, endocrine, pain Medication administration
information Teaching and compliance Insurance Information Insurance carriers Insurance
coverage Reimbursement variances
