Questionnaire Follow=up Study Sonia 2 (QSonia)

May 27, 2022 updated by: Emily Luangrath, Liverpool University Hospitals NHS Foundation Trust
Survey of health of patients completing SONIA 2 study: A cross-sectional analysis by questionnaire

Study Overview

Detailed Description

The Liverpool site will post the once only, short questionnaire (in the correct language using translated documents as appropriate) to the address of those patients who completed SONIA 2. Hospital approved translation services will be used. A return-addressed stamped envelope for ease of return will also be provided. Those who received nitisinone will be sent the nitisinone-administration questionnaire and those who did not receive nitisinone will be sent a no-nitisinone questionnaire

Study Type

Observational

Enrollment (Anticipated)

3

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

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

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cross-sectional cohort who completed SONIA 2 Study

Description

Inclusion Criteria:

- Documented diagnosis of AKU. Age ≥16 years.

Exclusion Criteria:

- Not completed SONIA 2 study for the full 4-year duration.

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: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to collect information on their health status since completing participation in SONIA 2
Time Frame: 12 months
All of the SONIA 2 completed questionnaire data collection is completed by 2 Sept 2020
12 months

Collaborators and Investigators

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

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)

September 19, 2019

Primary Completion (Anticipated)

June 19, 2023

Study Completion (Anticipated)

June 19, 2023

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

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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