Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-30 @ 3:02 AM
Study NCT ID:
NCT04885868
Status:
UNKNOWN
Last Update Posted:
2021-05-13
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Acceptability of Autonomous Telemedicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-12', 'releaseDate': '2022-11-01'}], 'estimatedResultsFirstSubmitDate': '2022-11-01'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058442', 'term': 'Capsule Opacification'}], 'ancestors': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-05-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-09', 'studyFirstSubmitDate': '2021-04-29', 'studyFirstSubmitQcDate': '2021-05-09', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A score out of 10 rating the autonomous system', 'timeFrame': 'It is anticipated the study will occur over 3 months', 'description': 'The patient will score the autonomous system out of 10 and a subsection of patients will have qualitative interviews.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract After']}, 'descriptionModule': {'briefSummary': 'Patients will have an automated call supervised by a human clinician to check how they are after uncomplicated cataract surgery as part of their standard of care. The study aims to evaluate the acceptability of this system through a net promoter score and for a subsection of patients using a qualitative interview.', 'detailedDescription': "The study will be a qualitative cohort design. The target will be to recruit 1000 patients who meet the inclusion criteria and provide consent following the process set out below. This represents recruiting 75% of the total projected number of patients who will undergo cataract surgery during the trial period.\n\nCurrently at Buckinghamshire Healthcare NHS Trust patients who have uncomplicated cataract surgery are given post-op instructions and assessed for their suitability to undergo telephone follow-up by the nursing team in the discharge lounge. If deemed suitable for a telephone call (equivalent to the criteria for inclusion in this study, including the capacity to consent) a date to expect a telephone follow-up call is given. During the study these patients will also be given an information leaflet and information relating to the study by the nursing team.\n\nThe post-op telephone call occurs three weeks later and at the start of this call patients will be asked if they consent to take part as well as if they have any further questions. If they agree to participate in the study their follow-up will be conducted by the autonomous human supervised system as well as additional questions to determine the acceptability of the system. If they decline to participate or are unable to consent (for example, the unlikely event that their capacity has become impaired following surgery), they will have their follow-up conducted by a human clinician as per the current standard of care.\n\nFor those patients who provide consent the autonomous human supervised system comprises several conversational elements which occur in order:\n\n1. Greeting and introduction\n2. Identification of patient\n3. Cataract follow-up symptom questions\n4. Patient's queries and frequently asked questions\n5. Acceptability questions\n6. Closure of call\n\nIf all of the questions aren't asked by the autonomous system or the human supervisor feels additional information is required they can ask these at the end of the call. The patient may withdraw from the automated call at any point.\n\nUp to 50 patients (5% of total recruited) who consent to participate will be invited to take part in a subsequent structured telephone interview with a researcher to explore in greater depth their experience of using the system. The interview will last no more that 30 minutes and will be conducted within one week of the follow-up call.\n\nAnonymised data from the patient ratings will undergo standard statistical analysis. The qualitative responses to the reasons why they gave their score as well as the answers to the in-depth interviews will undergo thematic analysis to understand patients' perceptions of having the follow-up conducted by the autonomous human supervised system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing uncomplicated cataract surgery who are suitable for telephone follow up', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Routine, first or second eye cataract surgery with intraocular lens implantation without complications.\n* Above the age of 16.\n* Capacity to give consent\n* Access to a phone number.\n* Satisfactory command of English for a phone-based consultation.\n\nExclusion Criteria:\n\n* Combined glaucoma surgery\n* Retinal or glaucoma laser treatment\n* Corneal dystrophy or grafts\n* Combined vitreoretinal surgery'}, 'identificationModule': {'nctId': 'NCT04885868', 'briefTitle': 'Patient Acceptability of Autonomous Telemedicine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ufonia'}, 'officialTitle': 'Patient Acceptability of the Use of an Autonomous Telephone System for the Delivery of Clinical Follow-up Conversations After Cataract Surgery', 'orgStudyIdInfo': {'id': 'RXQ'}}, 'armsInterventionsModule': {'interventions': [{'name': 'This study assess acceptability of autonomous conversation as part of cataract surgery follow up.', 'type': 'OTHER', 'description': 'This study assess acceptability of autonomous conversation as part of cataract surgery follow up.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Guy Mole, BSc MBBS MSc', 'role': 'CONTACT', 'email': 'gm@ufonia.co', 'phone': '07760270520'}], 'overallOfficials': [{'name': 'Guy Mole, BSc MBBS MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ufonia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'The study findings will be submitted to a peer review journal within 6 months of study completion.', 'ipdSharing': 'YES', 'description': 'The researcher undertaking the qualitative interviews will get access to the patient identifier for those who have consented to take part in the interview so that they can access their contact details from the hospital record.', 'accessCriteria': 'This will likely be an open source journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ufonia', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Buckinghamshire Healthcare NHS Trust', 'class': 'OTHER'}, {'name': 'Innovate UK', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-01', 'type': 'RELEASE'}, {'date': '2023-09-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Ufonia'}}}}