Clinical trial NCT05465356: Patient Engagement With Digital Health Tools in Rheumatology
Official title: Patient Engagement With Digital Health Tools in Rheumatology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatic Disease
PROM
Keywords: digital tools
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All new patients referred to rheumatology outpatients + patients with inflammatory arthritis under follow up in rheumatology outpatients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with a non-inflammatory diagnosis
timeFrame: 3 years
measure: Clinician assessed DAS-28 score for patients with rheumatoid arthritis
timeFrame: 3 years
measure: Clinician assessed PsARC score for patients with psoriatic arthritis
timeFrame: 3 years
measure: Rate of response to digital questionnaires
timeFrame: 3 years
Secondary outcomes:
measure: PHQ8 scores in new patients completing pre-appointment questionnaires
timeFrame: 3 years
measure: GAD7 scores in new patients completing pre-appointment questionnaires
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Toby Garrood, FRCP, PhD
role: STUDY_CHAIR
References: