Health Insurance Literacy and Challenges in Accessing Health Services in Niemann-Pick

October 5, 2020 updated by: National Niemann-Pick Disease Foundation

Understanding Health Insurance Literacy and Challenges in Accessing Health Services in Niemann-Pick Disease Through the Eyes of Patients and Families

This study is a US based qualitative PRO research study to document the health insurance literacy as well as the patient experience in Niemann-Pick as it relates to accessing desired care, services and medications for patients.

The outcome of this research will be used to inform various other workstreams as NNPDF works to assist families.

The core research objectives are to understand the following from Niemann-Pick patients and their families in the US

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study is a US based qualitative PRO research study to document the health insurance literacy as well as the patient experience in Niemann-Pick as it relates to accessing desired care, services and medications for patients.

The outcome of this research will be used to inform various other workstreams as NNPDF works to assist families.

The core research objectives are to understand the following from Niemann-Pick patients and their families in the US;

  • Level of health insurance literacy through assessment of health insurance terminology, and self-reported insights regarding information seeking, document literacy and cognitive skills
  • If they have healthcare insurance, and if not, why not
  • Types (including name) of insurance by which Niemann-Pick families are covered
  • Information regarding Medicaid Waivers

  • Attributes of insurance plans including, but not limited to;

    • Deductible amounts for individual and family
    • Out of pocket maximums for individual and family
    • Insurance premiums
    • Associated Health Savings Accounts
    • Associated Cost Sharing requirements
    • Services, drugs and assistive devices covered
  • What the perceived out-of-pocket costs are for Niemann-Pick families (annually)
  • When out-of-pocket maximums are perceived to be met for Niemann-Pick families

  • Patient and HCP experience in terms of challenges with accessing desired care and coverage

    • Where are families experiencing challenges with accessing desired care and coverage? (drugs, assistive devices, services) Is it different for the different phenotypes of the disease?
    • What is the challenge? (financial, time, stress, others)
    • What is the life impact of that challenge? (work and educational impact, lack or delay of treatment, others)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

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
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Within the United States, patients or the parent/caregiver of patients who have been diagnosed with any of the 7 known subtypes of Niemann-Pick disease

Description

Inclusion Criteria:

  • Participant must be a person with Niemann-Pick disease who is 18 years or older or The parent/legal guardian of a person with Niemann-Pick disease. Please note: Parents whose child has passed on are able to participate in the RSVP. Parents whose child has passed on in the last two years are also able to participate in the interview. Please note that only one family member will be eligible to complete the RSVP and interview for one family.
  • Confirmed diagnosis of Niemann-Pick disease, confirmed by membership in the NNPDF or by provision of a proof of disease form
  • Able to read, write and communicate in English
  • Able to grant informed consent
  • Willing to complete a survey and RSVP, and to participate in a 30-minute telephone interview
  • Ability to view or receive a document from the interviewer before or during the interview (web browser, ability to receive a text, fax or document by mail)

Exclusion Criteria:

- Inability to meet any of the above 6 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Niemann-Pick Type A
Also referred to as Infantile Neurovisceral ASMD
Niemann-Pick Type A/B
Also referred to as Intermediate form or Chronic Neurovisceral ASMD
Niemann-Pick Type B
Also referred to as Chronic Visceral ASMD
Niemann-Pick Type C (Early Infantile)
Onset at less than 2 years of age
Niemann-Pick Type C (Late Infantile)
Neurodegenerative form (late-infantile) onset at 2-6 years of age
Niemann-Pick Type C (Juvenile)
Neurodegenerative form (juvenile) onset at 6-15 years of age
Niemann-Pick Type C (Adult)
Psychiatric neurodegenerative form (adult) onset at greater than 15 years of age

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health Insurance Literacy
Time Frame: July 2020- September
Health insurance literacy will be measured by a score on a brief quiz regarding health insurance key terms as well as self-ratings regarding various aspects of the participants' ability to navigate and understand insurance
July 2020- September
Health Insurance Coverage
Time Frame: July 2020- September
Health insurance coverage will be measured by the different multiple choice and open-ended questions based on the services available under the participants' insurance plan as well as their reported difficulty with navigating their plan and obtaining what they need for Niemann-Pick
July 2020- September

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Niemann-Pick Disease Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Icahn School of Medicine at Mount Sinai
Engage Health Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: George A Diaz, MD, PhD, Icahn School of Medicine at Mount Sinai
  • Study Chair: Justin Hopkin, MD, National Niemann-Pick Disease Board Chair

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NNPDF-BUR001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data for each question in the study will be analyzed and reported by Engage Health using descriptive statistics as appropriate for the nature of the data collected-frequency distributions, cross tabulations and measures of central tendency and dispersion.

IPD Sharing Time Frame

September 2020

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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