NCT05465356

Brief Summary

The purpose of this study is to evaluate the patient engagement with digital tools for diagnosis and monitoring of disease in rheumatology services

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Status
unknown

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

June 22, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

June 22, 2022

Last Update Submit

July 15, 2022

Conditions

Keywords

digital tools

Outcome Measures

Primary Outcomes (4)

  • Number of patients with a non-inflammatory diagnosis

    Clinician assessed diagnosis as categorised into inflammatory \[e.g. rheumatoid arthritis\] or non-inflammatory \[e.g osteoarthritis or fibromyalgia\]

    3 years

  • Clinician assessed DAS-28 score for patients with rheumatoid arthritis

    Clinician assessment of disease activity at next follow-up visit for remote monitoring questionnaires

    3 years

  • Clinician assessed PsARC score for patients with psoriatic arthritis

    Clinician assessment of disease activity at next follow-up visit for remote monitoring questionnaires

    3 years

  • Rate of response to digital questionnaires

    Proportion of patients completing the new patient pre-appointment and follow-up remote monitoring questionnaires.

    3 years

Secondary Outcomes (2)

  • PHQ8 scores in new patients completing pre-appointment questionnaires

    3 years

  • GAD7 scores in new patients completing pre-appointment questionnaires

    3 years

Study Arms (2)

New patients

All new referrals seen in the rheumatology outpatients department, completing pre-appointment digital questionnaires

Other: QuestionnaireOther: Semi-structured interview

Follow-up patients

Patient with inflammatory arthritis completing ePROMs \[electronic Patient Reported Outcome Measures\] through the remote monitoring platform

Other: QuestionnaireOther: Semi-structured interview

Interventions

Questionnaires completed as part of routine care - this is an observational study

Follow-up patientsNew patients

Semi-structured interview to review factors involved in patients engaging or not-engaging with the digital tools

Follow-up patientsNew patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All new patients referred to rheumatology outpatients + patients with inflammatory arthritis under follow up in rheumatology outpatients

You may qualify if:

  • Aged 18 years and above
  • Able to complete the questionnaire in English
  • \. New patient pre-appointment questionnaires
  • Referred as a new patient to the rheumatology outpatient department at Guys and St Thomas' Trust between 01/01/2019 to 01/10/2023 and sent a digital pre-appointment questionnaire
  • Electronic patient notes recorded between 01/01/2019 to 01/10/2024
  • \. Follow up patients PROM questionnaires
  • Patients under followup of the rheumatology department at Guys and St Thomas' Trust with a diagnosis of rheumatoid arthritis, psoriatic arthritis or axial spondyloarthropathy who have been added to the remote monitoring program between 01/01/2019 to 01/10/2023
  • Electronic patient notes recorded between 01/01/2019 to 01/10/2024
  • Aged 18 years and above
  • \. New patient pre-appointment questionnaires
  • Referred as a new patient to the rheumatology outpatient department at Guys and St Thomas' Trust between 01/01/2019 to 01/10/2023 and sent a digital pre-appointment questionnaire
  • Able to communicate in English or any language offered for audio interpreting by the LanguageLine service
  • \. Follow up patients PROM questionnaires
  • Patients under followup of the rheumatology department at Guys and St Thomas' Trust with a diagnosis of rheumatoid arthritis, psoriatic arthritis or axial spondyloarthropathy who have been added to the remote monitoring program between 01/01/2019 to 01/10/2023
  • Able to communicate in English or any language offered for audio interpreting by the LanguageLine service

You may not qualify if:

  • Under 18 years of age
  • Unable to complete study questionnaires
  • Under 18 years of age
  • Patients lacking the capacity to consent for themselves for the semi-structured interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rheumatic Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Toby Garrood, FRCP, PhD

    Guy's and St Thomas' NHS Foundation Trust

    STUDY CHAIR

Central Study Contacts

Nikita Arumalla, MBBS, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 22, 2022

First Posted

July 19, 2022

Study Start

July 1, 2022

Primary Completion

October 1, 2024

Study Completion

July 1, 2025

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share