Nephrotic SyndromeNCT02190955
Assessment of the Educational Experiences for Patients Newly Diagnosed With Nephrotic Syndrome
An observational study of Nephrotic Syndrome, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this study is to learn about patient, caregiver and healthcare worker perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to participate in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2014
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients and caregivers were recruited from the Nephrotic Syndrome Study Network (NEPTUNE) Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and have already provided permission to be contacted for future research studies. The Contact Registry was created to inform patients and/or parents of patients with Nephrotic Syndrome of clinical research studies. Health professionals, including pediatric and internal medicine nephrologists and nephrology nurses will be recruited from the 18 NEPTUNE study network sites.
Who may be able to join
- Patient and Patient Caregiver:
- 18 years or older
- English literate
- History of Nephrotic Syndrome > 3 months or caregiver of a child diagnosed with Nephrotic Syndrome > 3 months prior to enrollment
- Informed Consent
- Healthcare Worker Inclusion Criteria:
Show all 10Show fewer
- Age > 18 years
- English literate
- Provides medical care for children or adults with Nephrotic Syndrome
- Informed Consent
Who cannot join
- Inability to provide informed consent and complete survey
- Other criteria as specified by Consortium and based on the data we collect in the Contact Registry
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida Data Management and Coordinating Center
Tampa, Florida, 33612
About this study
Official title: Assessment of the Educational Experience for Patients With Newly Diagnosed Nephrotic Syndrome
The purpose of this study is to learn about patient, caregiver and healthcare worker perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to participate in this study.
Read the detailed description
The survey included questions addressing the following areas: 1.) Information that is important to know when learning to manage Nephrotic Syndrome. 2.) Preferred resources for the education of patients and caregivers with newly-diagnosed Nephrotic Syndrome. 3.) The time frame required to acquire confidence in the management of Nephrotic Syndrome. 4.) Disease-specific information such as diagnosis, length of disease duration, medications used, need for kidney biopsy, dialysis and/or transplant. 5.) Demographic data such as race/ethnicity and educational background.
The survey data is stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected. Upon conclusion of the study period, the data will be sent to the NEPTUNE consortium lead at the University of Michigan.
- Conditions
- Nephrotic Syndrome
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| NEPTUNE contact registry patients | Patients and caregivers will be recruited from the Nephrotic Syndrome Study Network (NEPTUNE) Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and have already provided permission to be contacted for future research studies. Analysis of the one-time online questionnaire will be done in collaboration with investigators from the NEPTUNE Consortium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients
The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
Measured: 1 year after the study is closed to enrollment
Secondary outcomes (1)
Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome
The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
Measured: 1 year after the study is closed to enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 186 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Maine Medical Partners, C.S. Mott Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Marie Tanzer, MD, Study chair, Maine Medical PartnersDebbie Gipson, MD, Study chair, C.S. Mott Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190955
- Sponsor's protocol ID
- 6802
- Status last verified
- Jun 2014
- First submitted
- 30 May 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Educational Experience for Patients With Newly Diagnosed Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT02190955
- Acronym / sponsor ID
- 6802
- Conditions
- Nephrotic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Maine Medical Partners, C.S. Mott Children's Hospital
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about patient, caregiver and healthcare worker perspectives on educating patients with newly-diagnosed Nephrotic Syndrome. All patients enrolled in the Contact Registry with Nephrotic Syndrome will be invited via email to participate in this study.
Detailed description
The survey included questions addressing the following areas: 1.) Information that is important to know when learning to manage Nephrotic Syndrome. 2.) Preferred resources for the education of patients and caregivers with newly-diagnosed Nephrotic Syndrome. 3.) The time frame required to acquire confidence in the management of Nephrotic Syndrome. 4.) Disease-specific information such as diagnosis, length of disease duration, medications used, need for kidney biopsy, dialysis and/or transplant. 5.) Demographic data such as race/ethnicity and educational background.
The survey data is stored by the Rare Diseases Clinical Research Network's Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected. Upon conclusion of the study period, the data will be sent to the NEPTUNE consortium lead at the University of Michigan.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEPTUNE contact registry patients | – | –Patients and caregivers will be recruited from the Nephrotic Syndrome Study Network (NEPTUNE) Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and have already provided permission to be contacted for future research studies. Analysis of the one-time online questionnaire will be done in collaboration with investigators from the NEPTUNE Consortium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and caregivers were recruited from the Nephrotic Syndrome Study Network (NEPTUNE) Patient Contact Registry. Over 1000 patients and caregivers are members of the registry and have already provided permission to be contacted for future research studies. The Contact Registry was created to inform patients and/or parents of patients with Nephrotic Syndrome of clinical research studies. Health professionals, including pediatric and internal medicine nephrologists and nephrology nurses will be recruited from the 18 NEPTUNE study network sites.
Key inclusion criteria (10 listed)
- 18 years or older
- English literate
- History of Nephrotic Syndrome > 3 months or caregiver of a child diagnosed with Nephrotic Syndrome > 3 months prior to enrollment
- Informed Consent
- Age > 18 years
Key exclusion criteria (2 listed)
- Inability to provide informed consent and complete survey
- Other criteria as specified by Consortium and based on the data we collect in the Contact Registry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients
Time frame: 1 year after the study is closed to enrollment
The outcome measure(s) will be evaluated based on the cross-sectional online questionnaire. The questionnaire is the only study procedure for this online patient contact registry protocol and will be the sole analysis tool for both the primary and secondary outcome measures.
1 secondary outcome
Perspectives of patients/families with healthcare workers regarding educational needs of newly-diagnosed Nephrotic Syndrome
Time frame: 1 year after the study is closed to enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Tanzer, MD study chair
Maine Medical Partners
Debbie Gipson, MD study chair
C.S. Mott Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrotic Syndrome, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stakeholder perspectives about educational experiences of newly-diagnosed Nephrotic Syndrome patients (time frame: 1 year after the study is closed to enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2014.