Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT05465356
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2022-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Engagement With Digital Health Tools in Rheumatology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012216', 'term': 'Rheumatic Diseases'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-15', 'studyFirstSubmitDate': '2022-06-22', 'studyFirstSubmitQcDate': '2022-07-15', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with a non-inflammatory diagnosis', 'timeFrame': '3 years', 'description': 'Clinician assessed diagnosis as categorised into inflammatory \\[e.g. rheumatoid arthritis\\] or non-inflammatory \\[e.g osteoarthritis or fibromyalgia\\]'}, {'measure': 'Clinician assessed DAS-28 score for patients with rheumatoid arthritis', 'timeFrame': '3 years', 'description': 'Clinician assessment of disease activity at next follow-up visit for remote monitoring questionnaires'}, {'measure': 'Clinician assessed PsARC score for patients with psoriatic arthritis', 'timeFrame': '3 years', 'description': 'Clinician assessment of disease activity at next follow-up visit for remote monitoring questionnaires'}, {'measure': 'Rate of response to digital questionnaires', 'timeFrame': '3 years', 'description': 'Proportion of patients completing the new patient pre-appointment and follow-up remote monitoring questionnaires.'}], 'secondaryOutcomes': [{'measure': 'PHQ8 scores in new patients completing pre-appointment questionnaires', 'timeFrame': '3 years', 'description': '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'}, {'measure': 'GAD7 scores in new patients completing pre-appointment questionnaires', 'timeFrame': '3 years', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['digital tools'], 'conditions': ['Rheumatic Disease', 'PROM']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the patient engagement with digital tools for diagnosis and monitoring of disease in rheumatology services', 'detailedDescription': '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.\n\nThe 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.\n\nOur study aims to evaluate these questionnaires using data collected from routine clinical practice, as well a series of semi-structured interviews with service users.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All new patients referred to rheumatology outpatients + patients with inflammatory arthritis under follow up in rheumatology outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: quantitative phase:\n\n* Aged 18 years and above\n* Able to complete the questionnaire in English\n\n 1\\. New patient pre-appointment questionnaires\n* 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\n* Electronic patient notes recorded between 01/01/2019 to 01/10/2024\n\n 2\\. Follow up patients PROM questionnaires\n* 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\n* Electronic patient notes recorded between 01/01/2019 to 01/10/2024\n\nInclusion criteria: qualitative phase:\n\n* Aged 18 years and above\n\n 1\\. New patient pre-appointment questionnaires\n* 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\n* Able to communicate in English or any language offered for audio interpreting by the LanguageLine service\n\n 2\\. Follow up patients PROM questionnaires\n* 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\n* Able to communicate in English or any language offered for audio interpreting by the LanguageLine service\n\nExclusion Criteria: quantitative phase:\n\n* Under 18 years of age\n* Unable to complete study questionnaires\n\nExclusion criteria: qualitative phase:\n\n* Under 18 years of age\n* Patients lacking the capacity to consent for themselves for the semi-structured interview"}, 'identificationModule': {'nctId': 'NCT05465356', 'briefTitle': 'Patient Engagement With Digital Health Tools in Rheumatology', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Patient Engagement With Digital Health Tools in Rheumatology', 'orgStudyIdInfo': {'id': 'EDGE 147423'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New patients', 'description': 'All new referrals seen in the rheumatology outpatients department, completing pre-appointment digital questionnaires', 'interventionNames': ['Other: Questionnaire', 'Other: Semi-structured interview']}, {'label': 'Follow-up patients', 'description': 'Patient with inflammatory arthritis completing ePROMs \\[electronic Patient Reported Outcome Measures\\] through the remote monitoring platform', 'interventionNames': ['Other: Questionnaire', 'Other: Semi-structured interview']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaires completed as part of routine care - this is an observational study', 'armGroupLabels': ['Follow-up patients', 'New patients']}, {'name': 'Semi-structured interview', 'type': 'OTHER', 'description': 'Semi-structured interview to review factors involved in patients engaging or not-engaging with the digital tools', 'armGroupLabels': ['Follow-up patients', 'New patients']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nikita Arumalla, MBBS, BSc', 'role': 'CONTACT', 'email': 'nikita.arumalla@gstt.nhs.uk', 'phone': '07834958748'}], 'overallOfficials': [{'name': 'Toby Garrood, FRCP, PhD', 'role': 'STUDY_CHAIR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Nikita Arumalla', 'investigatorAffiliation': "Guy's and St Thomas' NHS Foundation Trust"}}}}