Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02328456
Status:
COMPLETED
Last Update Posted:
2016-04-15
First Post:
2014-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of SMS Reminder and Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013097', 'term': 'Spermine Synthase'}], 'ancestors': [{'id': 'D019883', 'term': 'Alkyl and Aryl Transferases'}, {'id': 'D014166', 'term': 'Transferases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 209}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2014-12-23', 'studyFirstSubmitQcDate': '2014-12-30', 'lastUpdatePostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Not-attended rate', 'timeFrame': 'up to 1 year', 'description': 'Compare the SMS and free eye drops patient not-attend rate with the control group to show the impact of SMS reminder associated with free eye drops on the adherence with scheduled follow-up visit'}], 'secondaryOutcomes': [{'measure': 'Knowledge and Attitudes about glaucoma, glaucoma surgery and importance of follow-up using a questionnaire', 'timeFrame': 'up to 1 year', 'description': 'Using a questionnaire to compare Knowledge and Attitude between the SMS associated with free eye drops group and the control group'}, {'measure': 'Additional factors potentially associated with post-operative follow-up using a patient questionnaire', 'timeFrame': 'up to 1 year', 'description': 'Using a patient questionnaire to compare between the SMS associated with free eye drops group and the control group'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Glaucoma', 'Adherence']}, 'referencesModule': {'references': [{'pmid': '27541442', 'type': 'DERIVED', 'citation': 'Yang K, Jin L, Li L, Zeng S, Wei R, Li G, Man P, Congdon N. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1135-1141. doi: 10.1001/jamaophthalmol.2016.2819.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to use a randomized controlled design to determine the impact of a SMS messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural China.', 'detailedDescription': 'SMS message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. The investigators can use the SMS system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All the patients after trabeculectomy surgery in 4 cooperated rural hospitals\n\nExclusion Criteria:\n\n* Both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the SMS function."}, 'identificationModule': {'nctId': 'NCT02328456', 'briefTitle': 'Effect of SMS Reminder and Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'A Randomized Controlled Trail to Determine the Impact of a SMS Reminder Associated With Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China', 'orgStudyIdInfo': {'id': 'ZOC-CREST-COMPLIANCE-GLAUCOMA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'SMS and free eye drops group', 'description': 'the patient after trabeculectomy surgery in the SMS associated with free eye drops group will receive free eye drops and a SMS reminder message about the revisit time.', 'interventionNames': ['Other: SMS and free eye drops']}, {'type': 'NO_INTERVENTION', 'label': 'the control group', 'description': "the patient after trabeculectomy surgery in the control group won't get any free eye drop and reminder message before the appointment."}], 'interventions': [{'name': 'SMS and free eye drops', 'type': 'OTHER', 'description': 'The SMS reminder message will sent to the SMS associated with free eye drops group patients 1 week and 1 day before there appointment to remind them the exact time and address of the revisit appointment.The eye drops will be offered free to the the SMS associated with free eye drops group patients when they revisit on time.', 'armGroupLabels': ['SMS and free eye drops group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Blindness Preventment and Treatment Department', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Nathan G Congdon, MD,MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'China,Guangdong,Blindness Preventment and Treatment Department,Zhongshan Ophthalmic Center,510060'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Congdon Nathan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orbis', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'vice directior,Blindness Prevention and Treatment Department', 'investigatorFullName': 'Congdon Nathan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}