Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-06 @ 4:42 PM
Study NCT ID:
NCT07488234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2025-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of a Glaucoma Awareness Program on Treatment Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2025-12-30', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment adherence scores', 'timeFrame': '10 months', 'description': 'Treatment adherence will be assessed using Glaucoma Treatment Compliance Assessment Tool- Short Form(GTCAT-S).\n\nTreatment adherence will be assessed using the Glaucoma Treatment Compliance Assessment Tool-Short Form (GTCAT-S), a validated self-administered questionnaire designed to evaluate adherence behavior, beliefs, and barriers among glaucoma patients. Approval for the use of GTCAT-S in this study has been obtained from the GTCAT development team.\n\nScale Details:\n\n* Each item is scored on a 5-point Likert scale: 1 = Disagree a lot to 5 = Agree a lot\n* Patients classified\n\n * Low adherence: \\<75%\n * High adherence: ≥75%\n* Direction:\n\nHigher scores indicate better treatment adherence'}], 'secondaryOutcomes': [{'measure': "Participants' perceptions of the glaucoma awareness program assessed using semi-structured interview guide", 'timeFrame': '3 months post-intervention', 'description': "Participants' perceptions of the glaucoma awareness program, including perceived usefulness, clarity of information, behavioral impact, barriers to treatment adherence, and suggestions for improvement, will be assessed through semi-structured in-depth interviews conducted at three months post-intervention.\n\nAssessment Method:\n\n* Semi-structured interview guide developed by the research team\n* Open-ended questions exploring:\n* Understanding of glaucoma\n* Perceived benefits of the awareness program\n* Barriers to applying learned information\n* Suggestions for improving patient education\n* Interviews will be audio-recorded, transcribed verbatim, translated into English, and analyzed using thematic analysis Scale Used: Not applicable (qualitative assessment; no numerical scoring)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glaucoma', 'Glaucoma awareness program', 'Treatment adherence', 'Patient education', 'Nepal'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': "Glaucoma is a leading cause of irreversible blindness worldwide, with a higher burden in low- and middle-income countries such as Nepal, where public awareness and treatment adherence remain poor. Lifelong adherence to treatment is important to prevent disease progression but still non adherence remains common.\n\nThis is a mixed method study which aims to evaluate the effectiveness of structured glaucoma awareness program in improving treatment adherence among glaucoma patients attending a tertiary eye hospital in Nepal. Quantitative assessment will measure changes in treatment adherence using Medication Adherence Scale at baseline and three months post intervention. A qualitative component will explore participants' perceptions of glaucoma program and suggestions for improvement through semi-structured interviews.", 'detailedDescription': "A mixed method interventional study will be conducted to assess the impact of a structured glaucoma awareness program on treatment adherence among the glaucoma follow-up patients attending a tertiary eye hospital in Nepal. The total study duration will be 10 months including preparation, participant recruitment, awareness program and follow up after 3 months, data analysis and reporting.\n\nThe primary objective of this study is to compare the treatment adherence scores of glaucoma patients before and three months after participation in the glaucoma awareness program.\n\nThe secondary objective is to qualitatively explore the participants' perceptions of the awareness program, identify barriers to treatment adherence and get the suggestions for improving patient education.\n\nPatient ≥18 years with pre-existing diagnosis of glaucoma attending routine follow up visits will be invited to participate. All the eligible patients who meet the inclusion criteria will be selected. A formal sample size calculation will be performed prior to recruitment. Based on prior literature, a target sample size of approximately 60 participants is anticipated to provide adequate statistical power. After obtaining a written informed consent, participants will complete a baseline self-reported questionnaire assessing demographics and treatment adherence using the validated medication adherence scale.\n\nParticipants will then attend a structured 30-minute glaucoma awareness program consisting of a PowerPoint presentation covering foundational concepts of glaucoma and related risk factors, disease progression, and the importance of treatment adherence. An illustrated one-page informational leaflet in simple Nepali will be distributed to all participants. An interactive question-and-answer session will be conducted to respond to queries. To ensure the program is inclusive and accessible for glaucoma patients with visual impairment, power point slides and leaflets will use large fonts, high contrast and simple illustration. Key messages and visual content will be reinforced verbally. Participants will be encouraged to ask questions and clarification will be provided as needed.\n\nAt three months post-intervention, same participants will be contacted by telephone by the principle investigator to reassess treatment adherence using the same validated tools. Quantitative data will be analyzed using paired statistical tests to compare pre- and post-intervention outcomes.\n\nA selected sub sample of approximately 8 - 10 participants will undergo semi-structured qualitative interviews three months after the awareness program, to explore their experiences with the awareness program, perceived benefits, barriers to implementing learned behaviors, and recommendations for improvement. Interviews will be audio-recorded, transcribed verbatim, translated into English, and analyzed using thematic analysis.\n\nThe study will receive approval from NHRC. Confidentiality will be maintained through anonymization of data, and participants may withdraw at any time without impact on their medical care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - Adults aged ≥18 years\n\n* Diagnosed with glaucoma\n* Attending follow-up at the study hospital\n* Able to provide informed consent\n* Able to communicate in Nepali language\n\nExclusion Criteria:\n\nIndividuals with cognitive impairments; healthcare professionals; individuals who have participated in a formal glaucoma education program in the past year.'}, 'identificationModule': {'nctId': 'NCT07488234', 'briefTitle': 'Impact of a Glaucoma Awareness Program on Treatment Adherence', 'organization': {'class': 'OTHER', 'fullName': 'Seva Canada Society'}, 'officialTitle': 'Assessing the Impact of a Structured Glaucoma Awareness Program on Treatment Adherence Among Glaucoma Patients at Tertiary Eye Hospital in Nepal', 'orgStudyIdInfo': {'id': 'REMEH/ORCB/1/20251220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glaucoma awareness', 'description': 'Glaucoma awareness educational package: Educational session, information leaflets, interactive discussions', 'interventionNames': ['Other: Glaucoma awareness and patient education program']}], 'interventions': [{'name': 'Glaucoma awareness and patient education program', 'type': 'OTHER', 'description': 'Glaucoma awareness educational package: Educational session, information leaflets, interactive discussions.\n\nThis study involves a behavioral/educational intervention only. No drugs, devices, or procedures are introduced as part of the study intervention. Participants continue their routine standard-of-care glaucoma treatment as prescribed by their treating ophthalmologist.\n\nNo investigational drugs or devices are used as part of this study. Participants continue their usual prescribed anti-glaucoma medications as part of routine clinical care. The study intervention consists solely of a structured educational and awareness program.', 'armGroupLabels': ['Glaucoma awareness']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dr. Deekshya Malla', 'role': 'CONTACT', 'email': 'deekshyamalla@gmail.com', 'phone': '+977 9851182007'}], 'overallOfficials': [{'name': 'Priya Adisesha Reddy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Seva Canada Society'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seva Canada Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Reiyukai Eiko Masunaga Eye Hospital (REMEH)', 'class': 'UNKNOWN'}, {'name': 'Pragyaan Sustainable Health Outcomes Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}