Patient Engagement With Digital Health Tools in Rheumatology

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05465356
Collaborator
(none)
3,000
36

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire
  • Other: Semi-structured interview

Detailed Description

The investigators plan to undertake a mixed methods study to investigate a digital algorithm to potentially inform triage of new patient referral to rheumatology services, as well as to inform follow up review schedules. Current practice at out hospital is to ask all newly referred patients to complete a pre-appointment digital questionnaire prior to their clinic visit. Patients who need follow up are then routinely invited to continue to return interval questionnaires related to their symptoms between clinic visits.

The investigators believe that the questionnaire responses could enable appropriate (and safe) allocation to a particular clinic (e.g. urgent early arthritis clinic or general rheumatology clinic for a new referral), or define an appropriate clinic follow up interval for a repeat visit for patients with a rheumatic disease.

Our study aims to evaluate these questionnaires using data collected from routine clinical practice, as well a series of semi-structured interviews with service users.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Patient Engagement With Digital Health Tools in Rheumatology
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
New patients

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

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

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

Follow-up patients

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Number of patients with a non-inflammatory diagnosis [3 years]

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

  2. Clinician assessed DAS-28 score for patients with rheumatoid arthritis [3 years]

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

  3. Clinician assessed PsARC score for patients with psoriatic arthritis [3 years]

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

  4. Rate of response to digital questionnaires [3 years]

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

Secondary Outcome Measures

  1. PHQ8 scores in new patients completing pre-appointment questionnaires [3 years]

    To estimate the prevalence of depression in new referrals to the rheumatology service. Score range 0 to 24, with higher score indicating more severe depression

  2. GAD7 scores in new patients completing pre-appointment questionnaires [3 years]

    To estimate the prevalence of anxiety in new referrals to the rheumatology service. Score range 0 to 21, with higher score indicating more severe anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria: quantitative phase:
  • Aged 18 years and above

  • Able to complete the questionnaire in English

  1. 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

  1. 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

Inclusion criteria: qualitative phase:
  • Aged 18 years and above
  1. 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

  1. 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

Exclusion Criteria: quantitative phase:
  • Under 18 years of age

  • Unable to complete study questionnaires

Exclusion criteria: qualitative phase:
  • Under 18 years of age

  • Patients lacking the capacity to consent for themselves for the semi-structured interview

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Study Chair: Toby Garrood, FRCP, PhD, Guy's and St Thomas' NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nikita Arumalla, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT05465356
Other Study ID Numbers:
  • EDGE 147423
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 19, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nikita Arumalla, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2022