NCT04341233

Brief Summary

The 19.5 months project will pilot the introduction of a hospital-based, nurse-led ankylosing spondylitis (AS) and psoriatic arthritis (PsA) service for patients being initiated on biologic therapy in NHS Lothian Edinburgh Western General Hospital. It is anticipated that this new model of care will improve:

  1. 1.The time from referral for biologic therapy to initiation of treatment with a biological therapy due to the dedicated nurse to see patients
  2. 2.The management and monitoring of AS and PsA patients post commencement of treatment , in line with The National Institute for Health and Care Excellence (NICE) guidelines

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

April 7, 2020

Last Update Submit

February 11, 2025

Conditions

Spondylitis, AnkylosingPsoriatic Arthritis

Keywords

Nurse-Led ServiceEnhanced Clinics

Outcome Measures

Primary Outcomes (8)

  • Setup a nurse-led clinic

    Appointing a nurse and training in biologic and DMARD counselling, clinical measures and clinic administration.

    3 months

  • Develop and setup a tool, an NHS Lothian Excel database

    Database enables trust to record data on the time taken to commence treatment with a biologic therapy from the point of initial referral to biologic therapy.

    19.5 months

  • Develop and setup a tool, an NHS Lothian Excel database

    Database enables trust to audit the results of the existing service for AS and PsA patients within the department (based on a cohort of 60 patients most recently initiated on biologics treatment within the department).

    19.5 months

  • Develop and setup a tool, an NHS Lothian Excel database

    Database enables trust to audit the results of the implementation of the clinic within the department.

    19.5 months

  • Develop and setup a tool, an NHS Lothian Excel database

    Database enables trust to assist with demonstrating that the care of patients within the clinic is in accordance with the NICE clinical guidelines and that there has been a reduction in the time to initiate biologic therapy at the end of the project against the baseline assessment.

    19.5 months

  • Develop and setup a tool, an NHS Lothian Excel database

    Database enables trust to develop a patient referral pathway into a new model of AS and PsA patient care, specifically in the nurse-led clinic.

    19.5 months

  • Develop and setup a tool, an NHS Lothian Excel database

    Database enables trust to utilise the new nurse-led clinic to improve consistency of care by reviewing and optimising biologic therapy for all new AS and PsA patients within the department according to NICE guideline recommendations.

    19.5 months

  • Develop and setup a tool, an NHS Lothian Excel database

    Database enables trust to use the evaluated model of care to enable NHS Lothian to build an informed business case to fund the continuation of this service in the future and expand it to all patients in their current service.

    19.5 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a diagnosis of ankylosing spondylitis or psoriatic arthritis requiring initiation of biologic therapy.

You may qualify if:

  • Clinical diagnosis of AS or PsA
  • Referral for initiation of biological therapy by patients regular consultant
  • Age 18 years or older
  • Willing and able to give informed consent

You may not qualify if:

  • · Unable to comply with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Spondylitis, AnkylosingArthritis, Psoriatic

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritisPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Neil McKay, Dr

    NHS Lothian

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 10, 2020

Study Start

August 1, 2020

Primary Completion

February 28, 2022

Study Completion

February 28, 2023

Last Updated

February 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share