Arthritis, RheumatoidNCT02402894
Follow-up of Person-centered Care of Young Adults With Rheumatic Disease
An observational study of Arthritis, Rheumatoid and Spondylarthritis, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
The purpose of the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. Read more about this study
- Who is it for?
- Ages 16 to 23 years
- Conditions the study is for
- Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic
- How many people
- 74 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2015to Dec 2022
- 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 16 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care. In total 100 patients, no healthy controls.
Who may be able to join
- 16-23 years
- newly diagnosed RA according to the ACR / EULAR 2010 criteria, SpA according to CASPAR criteria, or AS according to the ASAS criteria.
- Ability to understand the Swedish language in speech and writing.
Who cannot join
- Existing rheumatic disease
- Other healthcare demanding serious illness
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Reumatology, Sahlgrenska University Hospital, VastraGotaland
Gothenburg
About this study
Official title: Follow-up of Person-centered Care of Young Adults With Rheumatic Disease Uppföljning av Personcentrerat omhändertagande av Unga Vuxna Med Reumatisk Sjukdom (Unga-vuxna Studien) (Swedish)
The purpose of the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. Also included in the project is a long-term follow-up (up to 50 years) where the investigators want to investigate factors predicting good general health, low disease activity, good physical function, and comorbidity.
- Being tested
- no intervention
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
General health as measured by VAS
Measured: This study consists of a 1-year primary study and a long term follow-up (up to 50 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2021
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402894
- Sponsor's protocol ID
- 2014-10-08
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2015
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Person-centered Care of Young Adults With Rheumatic Disease Uppföljning av Personcentrerat omhändertagande av Unga Vuxna Med Reumatisk Sjukdom (Unga-vuxna Studien) (Swedish)
- ClinicalTrials.gov ID
- NCT02402894
- Acronym / sponsor ID
- 2014-10-08
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 30 Mar 2015 (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 the study is to study how a person-centered structured team caretaking of young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care affect and predict the patient's health and ability to manage their everyday lives. Also included in the project is a long-term follow-up (up to 50 years) where the investigators want to investigate factors predicting good general health, low disease activity, good physical function, and comorbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Young adults (16-23 years) with newly diagnosed rheumatoid arthritis (RA), spondartrit (SpA) and psoriasartrit (PsA) in routine clinical care. In total 100 patients, no healthy controls.
Key inclusion criteria (3 listed)
- 16-23 years
- newly diagnosed RA according to the ACR / EULAR 2010 criteria, SpA according to CASPAR criteria, or AS according to the ASAS criteria.
- Ability to understand the Swedish language in speech and writing.
Key exclusion criteria (2 listed)
- Existing rheumatic disease
- Other healthcare demanding serious illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention | Other | – |
Primary outcome
General health as measured by VAS
Time frame: This study consists of a 1-year primary study and a long term follow-up (up to 50 years)
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 24 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arthritis, Rheumatoid and Spondylarthritis, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 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 24 Apr 2024. 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 Sweden. 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?
General health as measured by VAS (time frame: This study consists of a 1-year primary study and a long term follow-up (up to 50 years)). 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 24 Apr 2024.