Patient Engagement With Digital Health Tools in Rheumatology

Not yet recruiting

• Conditions: Rheumatic Disease; PROM
• Interventions: Other: Questionnaire; Other: Semi-structured interview

• Registration Number: NCT05465356
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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

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 Timeline

• Study First Submitted: 2022-06-22
• Status Verified: 2022-07
• Study Start: 2022-07
• Study First Submitted QC: 2022-07-15
• Last Update Submitted: 2022-07-15
• Study First Posted: 2022-07-19
• Last Update Posted: 2022-07-19
• Primary Completion: 2024-10
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
New patients	Semi-structured interview	All new referrals seen in the rheumatology outpatients department, completing pre-appointment digital questionnaires
Follow-up patients	Questionnaire	Patient with inflammatory arthritis completing ePROMs \[electronic Patient Reported Outcome Measures\] through the remote monitoring platform
New patients	Questionnaire	All new referrals seen in the rheumatology outpatients department, completing pre-appointment digital questionnaires
Follow-up patients	Semi-structured interview	Patient with inflammatory arthritis completing ePROMs \[electronic Patient Reported Outcome Measures\] through the remote monitoring platform

Primary Outcome Measures

Name	Time	Method
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
Rate of response to digital questionnaires	3 years	Proportion of patients completing the new patient pre-appointment and follow-up remote monitoring questionnaires.
Number of patients with a non-inflammatory diagnosis	3 years	Clinician assessed diagnosis as categorised into inflammatory \[e.g. rheumatoid arthritis\] or non-inflammatory \[e.g osteoarthritis or fibromyalgia\]
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

Secondary Outcome Measures

Name	Time	Method
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
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