Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-17 @ 2:02 AM
Study NCT ID:
NCT06593405
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, DR and Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a quasi-experimental study to determine outcomes with occupational therapy (OT) medication management interventions/strategies for persons with Age-related Macular Degeneration (AMD)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2024-08-26', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revised Self Report Assessment of Functional Visual', 'timeFrame': 'Results from the Revised-Self-Report Assessment of Functional Visual Performance assessment will be determined on day 1 and 4 weeks later', 'description': 'A standardized assessment which provides information on how well adults with vision loss can perform daily tasks. This tool has 33 assessment components and a higher score indicates less functional impairment. A lower score indicates a higher impairment.'}, {'measure': 'MediCog Screening Tool', 'timeFrame': 'Results from the MediCog will be determined on day 1 and will be obtained 4 weeks later', 'description': 'The Medi-Cog has a maximum score of 10 points, and a score of 7 or lower may indicate cognitive impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '29309002', 'type': 'BACKGROUND', 'citation': "Occupational Therapy's Role in Medication Management. Am J Occup Ther. 2017 Nov/Dec;71(Supplement_2):7112410025p1-7112410025p20. doi: 10.5014/ajot.2017.716S02. No abstract available."}], 'seeAlsoLinks': [{'url': 'https://www.aota.org/publications/ot-practice/ot-practice-issues/2020/medication-adherence', 'label': 'American Occupational Therapy Association link to professional information'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if education about additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies will improve medication management skills. The main questions it aims to answer are:\n\nDoes additional task lighting, enhanced contrast, enlarged print instructions, smart apps and organizational strategies improve medication management skills, reduce errors and improve functional use of remaining vision for this task?\n\nParticipants will:\n\nOftentimes, the client is unaware of these strategies which may improve occupational performance during a valued activity. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills.', 'detailedDescription': 'Many clients with low vision are unaware of OT, or the services OT can provide to assist with low vision needs. Clients with AMD, DR or Glaucoma who choose to receive the one hour OT service will be provided with 1:1 education regarding the devices and strategies that may improve their ability to perform medication management skills. Clients will complete the MediCog and the Revised-Self-Report Assessment of Functional Visual Performance (R-SRAFVP) assessment tools with the assistance of the OT. These tools will inform the therapist to areas of client needs and allow for focus on intervention to support these challenges. Follow up in OT 4 weeks post intervention will allow therapist to reassess the effectiveness of interventions provided via a phone or in-person interview as well as provide the assessments again. Second set of data from these assessments will be compared to initial findings obtained.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clients with AMD, DR or Glaucoma\n* Clients who choose to participate will allow their deidentified data to be evaluated for outcomes.\n\nExclusion Criteria:\n\n* Clients with other age related eye diseases other than AMD, DR or Glaucoma.\n* Clients who do not wish to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06593405', 'briefTitle': 'The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, DR and Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'MCPHS University'}, 'officialTitle': 'The Role of Occupational Therapy for Improving Medication Management for Persons With AMD, Diabetic Retinopathy (DR) and Glaucoma', 'orgStudyIdInfo': {'id': 'IRB-2023-2024-84'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Receiving OT interventions', 'description': 'All participants will receive all OT interventions', 'interventionNames': ['Combination Product: occupational therapy interventions for low vision care']}], 'interventions': [{'name': 'occupational therapy interventions for low vision care', 'type': 'COMBINATION_PRODUCT', 'description': 'Occupational therapists utilize many different treatment strategies when caring for the client with low vision. Oftentimes, the client is unaware of these strategies which may improve occupational performance during a valued activity. Interventions include task lighting, organizational strategies, smart apps, contrast, enlarged print, typoscopes and electronic magnification devices.', 'armGroupLabels': ['Receiving OT interventions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01608', 'city': 'Worcester', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Dowling, Clinical Doctorate (OTD)', 'role': 'CONTACT', 'email': 'michelle.dowling@mcphs.edu', 'phone': '508-373-5851'}, {'name': 'Michelle Dowling, Clinical Doctorate', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MCPHS 10 Lincoln Square', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}], 'centralContacts': [{'name': 'Michelle Dowling, OTD', 'role': 'CONTACT', 'email': 'michelle.dowling@mcphs.edu', 'phone': '508-373-5851'}], 'overallOfficials': [{'name': 'Michelle Dowling, OTD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MCPHS University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after publication', 'ipdSharing': 'YES', 'description': 'Results will be analyzed and results will be shared in the form of publication in a peer reviewed journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MCPHS University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}