Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-02-03 @ 5:55 AM
Study NCT ID:
NCT02331732
Status:
UNKNOWN
Last Update Posted:
2015-09-25
First Post:
2014-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2014-12-13', 'studyFirstSubmitQcDate': '2015-01-05', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to medication', 'timeFrame': '2 weeks', 'description': 'Number of days per two week period that each patient fails to adhere to treatment, continuous. Panel data collected from TB-01 record sheets for duration of patient continuation phase of treatment - on average 5 months'}], 'secondaryOutcomes': [{'measure': 'Adherence 80%', 'timeFrame': '2 weeks', 'description': 'Proportion of patients having more than 80% of scheduled medication sessions per two week period (binary). Panel data collected for duration of patient continuation phase of treatment - on average 5 months'}, {'measure': 'Patient wellbeing', 'timeFrame': 'Collected at 4 months', 'description': 'Self reported using a short form version (5 questions) of the WEMWBS questionnaire for measuring mental wellbeing was developed by researchers at Warwick and Edinburgh Universities'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Collected at 4 months', 'description': 'Binary variable equal to 1 if a patient gives a positive response about their treatment on a likert scale (questionnaire, self-reported)'}, {'measure': 'Travel and time cost of treatment borne by patient, self reported.', 'timeFrame': 'Collected at 4 months', 'description': 'Total travel time and cost over 4 months (derived from questionnaire, self-reported)'}, {'measure': 'Employment, self reported', 'timeFrame': 'Collected at 4 months', 'description': 'Binary variable equal to 1 if patient currently does any work for pay or profit (questionnaire, self-reported)'}, {'measure': 'Treatment success', 'timeFrame': 'Collected at 4 months', 'description': 'Binary variable equal to 1 if treatment recorded a success on TB-01 patient record at 4 months'}, {'measure': 'Body mass index (BMI)', 'timeFrame': 'Collected at 4 months', 'description': 'Body mass index (BMI), measured at 4 months'}, {'measure': 'Side effects reported during treatment', 'timeFrame': 'Collected at 4 months', 'description': 'Binary variable equal to 1 if patient reported any side effects during treatment (questionnaire, self-reported)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '32381495', 'type': 'DERIVED', 'citation': 'Ravenscroft L, Kettle S, Persian R, Ruda S, Severin L, Doltu S, Schenck B, Loewenstein G. Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova. Eur Respir J. 2020 Aug 6;56(2):2000493. doi: 10.1183/13993003.00493-2020. Print 2020 Aug.'}]}, 'descriptionModule': {'briefSummary': "This trial aims to increase the wellbeing of tuberculosis patients and their adherence to medication in Chisinau, The Republic of Moldova. The design is an individually randomised controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of treatment. The trial will have two arms; 200 patients will form the control group and receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually Observed Treatment (VOT).\n\nVOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video messages rather than in-person. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. VOT allows patients to take their treatment in the comfort of their home and means they don't have to travel to their polyclinic every day.\n\nThere will be a central VOT observation centre where VOT observers will view and respond to video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health app. The VOT observers will also respond to the patients by sending feedback to the patients. The trial duration will depend on the recruitment rate of eligible patients but is expected to take 16 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Consent to being part of the trial\n2. Live in Chisinau and no plans to move away from Chisinau during the four months\n3. Aged 18 or over\n4. At least four months of care remaining\n\nExclusion Criteria:\n\n1. Having MDR-TB\n2. Homeless\n3. Is not homeless\n4. Suffer from alcoholism or drug misuse\n5. In prison\n6. Has a treatment regimen with injections'}, 'identificationModule': {'nctId': 'NCT02331732', 'briefTitle': 'Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova', 'organization': {'class': 'OTHER', 'fullName': 'The Behavioural Insights Team'}, 'orgStudyIdInfo': {'id': '201405*'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day', 'interventionNames': ['Other: Directly Observed Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Patients receive VOT - involves patient sending a video of themselves taking their treatment over M-health app which will be reviewed remotely by observers', 'interventionNames': ['Behavioral: Virtually Observed Treatment']}], 'interventions': [{'name': 'Virtually Observed Treatment', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Treatment']}, {'name': 'Directly Observed Treatment', 'type': 'OTHER', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Stewart Kettle Kettle, msc', 'role': 'CONTACT', 'email': 'stewart.kettle@behaviouralinsights.co.uk', 'phone': '+44 (0) 207 031 3530'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Behavioural Insights Team', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}