Rheumatic DiseaseNCT05465356
Patient Engagement With Digital Health Tools in Rheumatology
An observational study of Rheumatic Disease and PROM, run by Guy's and St Thomas' NHS Foundation Trust.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Disease, PROM
- What is being tested?
- Questionnaire and Semi-structured interview
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All new patients referred to rheumatology outpatients + patients with inflammatory arthritis under follow up in rheumatology outpatients
Who may be able to join
- 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
Show all 15Show fewer
- 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
- 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
Who cannot join
- Under 18 years of age
- Unable to complete study questionnaires
- Under 18 years of age
- Patients lacking the capacity to consent for themselves for the semi-structured interview
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to evaluate the patient engagement with digital tools for diagnosis and monitoring of disease in rheumatology services
Read the 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.
- Conditions
- Rheumatic Disease, PROM
- Being tested
- Questionnaire, Semi-structured interview
- Keywords
- digital tools
- Medical subject headings
- Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaires completed as part of routine care - this is an observational study
Semi-structured interviewOther
Semi-structured interview to review factors involved in patients engaging or not-engaging with the digital tools
| Study group | Role | What they receive |
|---|---|---|
| New patients | All new referrals seen in the rheumatology outpatients department, completing pre-appointment digital questionnaires Receives: Other: Questionnaire; Other: Semi-structured interview | |
| Follow-up patients | Patient with inflammatory arthritis completing ePROMs [electronic Patient Reported Outcome Measures] through the remote monitoring platform Receives: Other: Questionnaire; Other: Semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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
Measured: 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
Measured: 3 years
Rate of response to digital questionnaires
Proportion of patients completing the new patient pre-appointment and follow-up remote monitoring questionnaires.
Measured: 3 years
Secondary outcomes (2)
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
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikita Arumalla, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- Toby Garrood, FRCP, PhD, Study chair, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465356
- Sponsor's protocol ID
- EDGE 147423
- Status last verified
- Jul 2022
- First submitted
- 22 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Engagement With Digital Health Tools in Rheumatology
- ClinicalTrials.gov ID
- NCT05465356
- Acronym / sponsor ID
- EDGE 147423
- Conditions
- Rheumatic Disease, PROM
- Keywords
- digital tools
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New patients | – | Other: Questionnaire, Other: Semi-structured interviewAll new referrals seen in the rheumatology outpatients department, completing pre-appointment digital questionnaires |
| Follow-up patients | – | Other: Questionnaire, Other: Semi-structured interviewPatient with inflammatory arthritis completing ePROMs [electronic Patient Reported Outcome Measures] through the remote monitoring platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All new patients referred to rheumatology outpatients + patients with inflammatory arthritis under follow up in rheumatology outpatients
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (4 listed)
- Under 18 years of age
- Unable to complete study questionnaires
- Under 18 years of age
- Patients lacking the capacity to consent for themselves for the semi-structured interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaires completed as part of routine care - this is an observational study | Other | Follow-up patients, New patients |
| Semi-structured interviewSemi-structured interview to review factors involved in patients engaging or not-engaging with the digital tools | Other | Follow-up patients, New patients |
Primary outcome
Number of patients with a non-inflammatory diagnosis
Time frame: 3 years
Clinician assessed diagnosis as categorised into inflammatory [e.g. rheumatoid arthritis] or non-inflammatory [e.g osteoarthritis or fibromyalgia]
Clinician assessed DAS-28 score for patients with rheumatoid arthritis
Time frame: 3 years
Clinician assessment of disease activity at next follow-up visit for remote monitoring questionnaires
Clinician assessed PsARC score for patients with psoriatic arthritis
Time frame: 3 years
Clinician assessment of disease activity at next follow-up visit for remote monitoring questionnaires
Rate of response to digital questionnaires
Time frame: 3 years
Proportion of patients completing the new patient pre-appointment and follow-up remote monitoring questionnaires.
2 secondary outcomes
PHQ8 scores in new patients completing pre-appointment questionnaires
Time frame: 3 years
GAD7 scores in new patients completing pre-appointment questionnaires
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toby Garrood, FRCP, PhD study chair
Guy's and St Thomas' NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Disease and PROM, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikita Arumalla, MBBS, BSc (07834958748, nikita.arumalla@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a non-inflammatory diagnosis (time frame: 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.