Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-25 @ 12:19 AM
Study NCT ID:
NCT02717403
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2016-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Social Networking on Chronic Disease Management in Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D000097822', 'term': 'Media Exposure'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D012961', 'term': 'Sociology'}, {'id': 'D012942', 'term': 'Social Sciences'}, {'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-14', 'studyFirstSubmitDate': '2016-03-18', 'studyFirstSubmitQcDate': '2016-03-22', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Knowledge of Rheumatoid Arthritis assessed with the Patient Knowledge Questionnaire (PKQ-RA)', 'timeFrame': '6 months', 'description': 'The Patient Knowledge Questionnaire (PKQ-RA) will measure this outcome.'}], 'secondaryOutcomes': [{'measure': 'Control in Health Care Decisions assessed with the Control Preferences Scale (CPS-RA)', 'timeFrame': '6 months', 'description': 'The Control Preferences Scale (CPS-RA) used to measure the degree of control an individual wants to assume while making decisions about their health care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Disease Management', 'Rheumatoid Arthritis', 'Facebook', 'Social networking', 'Internet', 'Questionnaires', 'Surveys', 'Phone interview'], 'conditions': ['Chronic Disease Management', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '35872394', 'type': 'DERIVED', 'citation': 'Lopez-Olivo MA, Foreman JT, Leung C, Lin HY, Westrich-Robertson T, Hofstetter C, des Bordes JKA, Lyddiatt A, Leong A, Willcockson IU, Peterson SK, Suarez-Almazor ME. A randomized controlled trial evaluating the effects of social networking on chronic disease management in rheumatoid arthritis. Semin Arthritis Rheum. 2022 Oct;56:152072. doi: 10.1016/j.semarthrit.2022.152072. Epub 2022 Jul 16.'}], 'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'University of Texas MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': "Objectives:\n\nThe overall goal of this study is to use the principles of chronic disease management to develop and test an online social networking intervention using the FB platform in a randomized controlled trial. Our specific objectives are as follows:\n\nAim 1: To develop and establish an independent closed community in FB for patients with rheumatoid arthritis, providing an educational platform for disease self-management and the potential for engaging in social networking with peers (Phase 2).\n\nObjective 1. To beta test the features and navigation buttons and panels in the newly developed website and FB group.\n\nObjective 2. To evaluate the contents, ease of use and satisfaction with the newly developed website and FB group by patient advocates (consultants to the study) who participate as members of the Facebook community.\n\nAim 2: To evaluate the efficacy of the FB community intervention combined with an educational website to improve patients' self-management (including knowledge, which is the primary outcome), decision making and patient-reported outcomes compared with the educational website alone (Phase 3). We hypothesize that participation in an online closed community offering evidence-based information combined with peer interaction and support will improve patients' knowledge.", 'detailedDescription': 'Pilot Testing Phase:\n\nFive participants will be recruited to pilot test and give feedback on the control educational website and the FB community. Participants will have access to the educational website and FB, for a period of one week. The main purpose is to test ease of use and satisfaction with both platforms. After 1 week, research staff will call the participant to obtain feedback about the websites. The interview will last approximately 30 minutes and in the case the participant does not finish the interview, the investigators will conduct a follow-up phone interview.\n\nRandomization Phase:\n\nParticipants will complete a self response electronic questionnaire at baseline. Participants then randomized into one of two arms: Intervention (FB + Website) and Control (Website alone). The participant will be shown how to access the website and the Facebook page on the internet about rheumatoid arthritis. Patients will be assessed at three and six months after baseline via email self response electronic questionnaires. This phase will recruit 220 participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 years or older (usability test and RCT)\n2. Staff of the Department of General Internal Medicine (usability test)\n3. Diagnosis of rheumatoid arthritis by a rheumatologist (RCT)\n4. Ongoing or prior treatment with traditional disease-modifying anti-rheumatic drugs or biologic agents (RCT)\n5. Adequate cognitive status as determined by a research coordinator at recruitment. To assess the participant's capacity to take part in the interview, the interviewer will note and comment on the participant's spontaneous speech and capacity to write date at the time of consent. Participants should be oriented to person, place, date, time, and events (RCT)\n6. Living in the community (not institutionalized, etc. ) (RCT)\n7. Able to communicate in English (RCT)\n8. Use internet on average at-least once a week (RCT);\n9. Disease duration 10 years or less (RCT)\n10. Familiarity with and participation in social media (e.g. Facebook) (usability test and RCT)\n\nExclusion Criteria:\n\n1. Participants not willing to complete interviews or survey instruments (usability test and RCT)\n2. Hospitalized (RCT)\n3. Patients who do not verbally, written, or electronically consent to participate (usability test and RCT)"}, 'identificationModule': {'nctId': 'NCT02717403', 'briefTitle': 'Effects of Social Networking on Chronic Disease Management in Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase 2 & Phase 3, Effects of Social Networking on Chronic Disease Management in Arthritis', 'orgStudyIdInfo': {'id': '2015-0349'}, 'secondaryIdInfos': [{'id': '14038089', 'type': 'OTHER_GRANT', 'domain': 'Rheumatology Research Foundation'}, {'id': 'NCI-2016-00563', 'type': 'REGISTRY', 'domain': 'NCI CTRP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Facebook + Website Group', 'description': 'Participants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website and the Facebook page on the internet about rheumatoid arthritis. Patients assessed at three and six months after baseline via email self response electronic questionnaires.', 'interventionNames': ['Behavioral: Questionnaires', 'Behavioral: Facebook', 'Behavioral: Educational Website']}, {'type': 'EXPERIMENTAL', 'label': 'Educational Website Group', 'description': 'Participants complete a self response electronic questionnaire at baseline. Participant shown how to access the Educational Website on the internet about rheumatoid arthritis. Content includes the following: (i) a learning center; (ii) relevant links to other evidence-based web pages; (iii) news released by major rheumatology and dermatology organizations/societies; and (iv) chronic disease management strategies. Participants assessed at three and six months after baseline via email self response electronic questionnaires.', 'interventionNames': ['Behavioral: Questionnaires', 'Behavioral: Educational Website']}, {'type': 'EXPERIMENTAL', 'label': 'Pilot Testing Group', 'description': 'Participants access the Educational Website and Facebook page about rheumatoid arthritis for a period of one week. After 1 week, research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes.', 'interventionNames': ['Behavioral: Facebook', 'Behavioral: Educational Website', 'Behavioral: Phone Interview']}], 'interventions': [{'name': 'Questionnaires', 'type': 'BEHAVIORAL', 'otherNames': ['Surveys'], 'description': 'Participants complete a self response electronic questionnaire at baseline, and at three and six months.', 'armGroupLabels': ['Educational Website Group', 'Facebook + Website Group']}, {'name': 'Facebook', 'type': 'BEHAVIORAL', 'otherNames': ['Social Media'], 'description': 'Participant accesses Facebook page regarding rheumatoid arthritis.', 'armGroupLabels': ['Facebook + Website Group', 'Pilot Testing Group']}, {'name': 'Educational Website', 'type': 'BEHAVIORAL', 'description': 'Participant accesses Educational Website on the internet about rheumatoid arthritis.', 'armGroupLabels': ['Educational Website Group', 'Facebook + Website Group', 'Pilot Testing Group']}, {'name': 'Phone Interview', 'type': 'BEHAVIORAL', 'description': 'Research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes.', 'armGroupLabels': ['Pilot Testing Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Angeles M. Lopez-Olivo, MD, PHD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rheumatology Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}