Patient Engagement With Digital Health Tools in Rheumatology

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatic Disease; PROM
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Nikita Arumalla, MBBS, BSc; Phone Number: 07834958748; Email: nikita.arumalla@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

  2. 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

  2. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ8 scores in new patients completing pre-appointment questionnaires	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	3 years
GAD7 scores in new patients completing pre-appointment questionnaires	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	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2022
• Primary Completion (ANTICIPATED): October 1, 2024
• Study Completion (ANTICIPATED): July 1, 2025

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (ACTUAL): July 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 15, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: digital tools
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: EDGE 147423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No