Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-24 @ 6:38 PM
Study NCT ID:
NCT04245020
Status:
COMPLETED
Last Update Posted:
2021-04-26
First Post:
2019-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Comparing Three Methods of Outpatient Follow up After Surgical Admission; Text Message, Phone Call and In-person Appointment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2019-09-15', 'studyFirstSubmitQcDate': '2020-01-27', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications that require further follow up', 'timeFrame': '6-8 weeks', 'description': 'Complications are identified by patient record and follow up method selected'}], 'secondaryOutcomes': [{'measure': 'Satisfaction in follow up', 'timeFrame': '8-10 weeks', 'description': 'A questionnaire will assess how happy based on a survey patients were with their follow up method. The CSQ 8 score will be used along with a previously published questionnaire from this institiution. In the CSQ-8 questionnaire a higher score indicates more satisfaction.'}, {'measure': 'Willingness to use a virtual clinic app in the future', 'timeFrame': '8-10 weeks', 'description': 'A questionnaire will assess patients preference in further follow up, specifically are patients happy to use a telemedicine based app. (answer no definitely not, no not really, yes generally, yes definitely.'}, {'measure': 'Follow up preference', 'timeFrame': '8-10 weeks', 'description': 'Preferred follow up method will be identified by above patient questionnaire (text, phone or OPD)'}, {'measure': 'Lost to follow up', 'timeFrame': '6-8 weeks', 'description': 'number of patients that are lost to follow up per follow up method'}, {'measure': 'Further procedures arranged', 'timeFrame': '8-10 weeks', 'description': 'number of patients who have an additional procedure arranged which will be identified in the medical record'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomised control trial', 'Virtual clinic', 'Text messaging', 'General surgery', 'Outpatients', 'Satisfaction', 'Telemedicine'], 'conditions': ['Outpatients', 'Virtual Clinic', 'Text Messaging', 'General Surgery']}, 'descriptionModule': {'briefSummary': 'This study compares three different methods of outpatient follow up after surgical admission to Connolly Hospital Blanchardstown. The three arms of the study are text message, telephone call or in-person outpatient follow up. Data will be collected to identify complications identified in each arm along with the rate of non-response to the follow up methods and the level of satisfaction with the method. Willingness to use a telemedicine app in the future will also be evaluated through satisfaction survey.', 'detailedDescription': 'This is a non-blinded, single centre open randomised control trial of the outpatient follow up method following surgical admission to Connolly Hospital Blanchardstown.\n\nAll eligible patients will be randomised into three arms, text message, telephone or in-person follow up. The follow up will be carried out at 6-8 weeks following discharge. The rate of complications, the non-response rate and the level of satisfaction will be compared between the three groups.\n\nWillingness to use a telemedicine app in the future in place of an in-person follow up will also be measured by patient satisfaction questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical patients admitted either as an emergency or for an elective procedure\n* 16 years or older\n\nExclusion Criteria:\n\n* Did not consent or cannot give consent\n* Age less than 16\n* No smartphone\n* Further follow up required for treatment of further investigation\n* Diagnosis or suspected diagnosis of malignancy'}, 'identificationModule': {'nctId': 'NCT04245020', 'acronym': 'ISOTOPE', 'briefTitle': 'A Study Comparing Three Methods of Outpatient Follow up After Surgical Admission; Text Message, Phone Call and In-person Appointment', 'organization': {'class': 'OTHER', 'fullName': 'Connolly Hospital Blanchardstown'}, 'officialTitle': 'An Open Label Randomised Control Trial Comparing Three Methods of Outpatient Follow up After Surgical Admission in Connolly Hospital Blanchardstown; Text Message, Phone Call and In-person Appointment', 'orgStudyIdInfo': {'id': 'ISOTOPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Text Message', 'description': 'Patients will be followed up with a series of text messages at 6-8 weeks', 'interventionNames': ['Other: Text message follow up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telephone', 'description': 'Patients will be followed with a telephone conversation at 6-8 weeks', 'interventionNames': ['Other: Telephone follow up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'In person', 'description': 'Patients will be followed in person in the Outpatient department at 6-8 weeks', 'interventionNames': ['Other: In person follow up']}], 'interventions': [{'name': 'Text message follow up', 'type': 'OTHER', 'description': 'A text message will be sent to the patient 6-8 weeks following discharge', 'armGroupLabels': ['Text Message']}, {'name': 'Telephone follow up', 'type': 'OTHER', 'description': 'The patient will be followed up at 6-8 weeks following discharge with a telephone call', 'armGroupLabels': ['Telephone']}, {'name': 'In person follow up', 'type': 'OTHER', 'description': 'The patient will be followed up at 6-8 weeks following discharge in person in the outpatient department', 'armGroupLabels': ['In person']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D07 A59E', 'city': 'Dublin', 'state': 'Co. Dublin', 'country': 'Ireland', 'facility': 'Connolly Hospital Blanchardstown', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Paul M Cromwell, BM BS BA MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15'}, {'name': 'Thomas N Walsh, MD MCh FRCSI', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery, Connolly Hospital Blanchardstown, Dublin 15'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All data will be shared with other researchers if requested'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Connolly Hospital Blanchardstown', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgery SpR', 'investigatorFullName': 'Paul Cromwell', 'investigatorAffiliation': 'Connolly Hospital Blanchardstown'}}}}