Patient Engagement With Digital Health Tools in Rheumatology

Rheumatic Disease Clinical Trial

Official title:

Patient Engagement With Digital Health Tools in Rheumatology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05465356
• Other study ID #: EDGE 147423
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: July 2025

Study information

• Verified date: July 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Nikita Arumalla, MBBS, BSc
• Phone: 07834958748
• Email: nikita.arumalla[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: July 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• PROM
• Rheumatic Disease
• Rheumatic Diseases

Intervention

Other:
• Questionnaire
Questionnaires completed as part of routine care - this is an observational study
• Semi-structured interview
Semi-structured interview to review factors involved in patients engaging or not-engaging with the digital tools

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Rate of response to digital questionnaires	Proportion of patients completing the new patient pre-appointment and follow-up remote monitoring questionnaires.	3 years
Secondary	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
Secondary	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