Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00023205
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2001-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Literacy Level on Patient Education and Health Among People With Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'D001168', 'term': 'Arthritis'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-23', 'studyFirstSubmitDate': '2001-08-29', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Literacy-related problems encountered in management', 'timeFrame': '6 months and 12 months', 'description': 'Interview'}], 'primaryOutcomes': [{'measure': 'Adherence to treatment', 'timeFrame': '6 months, 12 months', 'description': 'self report of medication use on standard form'}, {'measure': 'Self efficacy', 'timeFrame': '6 months and 12 months', 'description': 'self report on self efficacy form'}, {'measure': 'Satisfaction with medical care', 'timeFrame': '6 months and 12 months', 'description': 'self report of satisfaction'}], 'secondaryOutcomes': [{'measure': 'Heath Status', 'timeFrame': '6 months and 12 months', 'description': 'Health Assessment questionaire'}, {'measure': 'Mental Health', 'timeFrame': '6 months and 12 months', 'description': 'SF-36 (5 items)'}, {'measure': 'Understanding of medication', 'timeFrame': '6 months and 12 months', 'description': 'open ended questionnaire of medication purpose'}, {'measure': 'Perceived usefulness of materials', 'timeFrame': '6months and 12 months', 'description': 'Interview'}, {'measure': 'Appointment keeping', 'timeFrame': '6 and 12 months', 'description': 'Clinical record'}]}, 'conditionsModule': {'keywords': ['Arthritis', 'Health literacy', 'Patient education', 'Self-efficacy'], 'conditions': ['Rheumatoid Arthritis', 'Psoriatic Arthritis', 'Polyarthritis']}, 'referencesModule': {'references': [{'pmid': '1580173', 'type': 'BACKGROUND', 'citation': "Weiss BD, Hart G, McGee DL, D'Estelle S. Health status of illiterate adults: relation between literacy and health status among persons with low literacy skills. J Am Board Fam Pract. 1992 May-Jun;5(3):257-64."}, {'type': 'BACKGROUND', 'citation': 'Kitsch I, A. Jungeblut, L. Jenkins, and A. Kolstad. Adult Literacy in America: A First Look at the Results of the National Adult Literacy Survey. Washington, DC: National Center for Education Statistics, US Department of Education; 1993.'}]}, 'descriptionModule': {'briefSummary': 'People with poor literacy may have worse health and less knowledge about how to manage their disease than patients at high reading levels. Patients with arthritis usually receive information on how to manage their disease that is written at an 11th grade reading level. The purpose of this study is to compare the health outcomes of patients with arthritis given either standard 11th grade level materials or interactive, in-person arthritis education along with materials written at a lower reading level.', 'detailedDescription': 'Patients with poor literacy report worse health and know less about managing their disease than patients with better literacy. This study will compare the disease outcomes of arthritis patients at three different reading levels who receive either standard arthritis materials written at an 11th grade reading level or an in-person, interactive, text-free session along with lower reading level materials. The study will determine the most effective methods of educating patients with poor literacy about their disease.\n\nPatients with systemic inflammatory rheumatic conditions (rheumatoid arthritis, psoriatic arthritis, and seronegative polyarthritis) will be assessed and placed into one of three reading levels: 8th grade or lower; 9th to 11th grade; or 12th grade or higher. Patients from each reading level will be randomly assigned to one of two intervention groups. Group 1 will receive disease-specific material from the Arthritis Foundation written at an 11th grade reading level. Group 2 will receive plain language materials, an arthritis glossary, and a one-hour, in-person session with a study educator using interactive, text-free methods. The study educator will help the patient with reading-related problems either by study visit or by telephone for 6 months postsession.\n\nAll patients will receive a medication calendar. Patients will be followed for one year after the intervention and will be assessed for changes in health status, disease activity, communication with the physician, self-management of their arthritis, understanding of and adherence to prescribed treatment, and satisfaction with their intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Native English speaker\n* Patient at the Rheumatology Clinic at Brigham and Women's Hospital, Boston, Massachusetts\n* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or seronegative polyarthritis"}, 'identificationModule': {'nctId': 'NCT00023205', 'briefTitle': 'Impact of Literacy Level on Patient Education and Health Among People With Arthritis', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Literacy in Arthritis Management: A Randomized Controlled Clinical Trial of a Novel Education Intervention', 'orgStudyIdInfo': {'id': 'P60 AR47782 NIAMS-068'}, 'secondaryIdInfos': [{'id': 'P60AR047782', 'link': 'https://reporter.nih.gov/quickSearch/P60AR047782', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Individualized education', 'description': 'Individualized education with materials written in plain language. Follow-up sessions/ phone contact as requested by the subject.', 'interventionNames': ['Behavioral: Interactive in-person arthritis education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': '1 session of education with provision of standard Arthritis Foundation materials.', 'interventionNames': ['Behavioral: 11th grade reading level arthritis materials']}], 'interventions': [{'name': '11th grade reading level arthritis materials', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Standard care']}, {'name': 'Interactive in-person arthritis education', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Individualized education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Matthew H. Liang, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Matthew H. Liang, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}