Follow-up of Person-centered Care of Young Adults With Rh... | NCT02402894

Studies
Follow-up of Person-centered Care of Young Adults With Rheumatic Disease

NCT02402894

Sponsor

Vastra Gotaland Region

Status

Completed

Last Update Posted

Apr 24, 2024Actual

Enrollment

74Actual

Phase

Not provided

Conditions

Arthritis, Rheumatoid
Spondylarthritis
Arthritis, Psoriatic

Interventions

no intervention

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Dec 2021Actual

Completion Date

Dec 2022Actual

First Submitted Date

Mar 25, 2015

First Submission Date that Met QC Criteria

Mar 27, 2015

First Posted Date

Mar 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2024

Last Update Posted Date

Apr 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
General health as measured by VAS		This study consists of a 1-year primary study and a long term follow-up (up to 50 years)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Existing rheumatic disease
Other healthcare demanding serious illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

23 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reumatology, Sahlgrenska University Hospital, VastraGotaland		Gothenburg			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D025241	Spondylarthritis
D015535	Arthritis, Psoriatic

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided