Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-04-18 @ 5:01 AM
Study NCT ID:
NCT01907269
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2013-07-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rahneli@uab.edu', 'phone': '2059966552', 'title': 'Dr. Elizabeth J. Rahn', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Low rates of osteoporosis treatment initiation; Self-reported fracture history subject to recall bias; Low % of participants reported fracture in 12-months prior to intervention; Low % of participants who interacted with intervention appreciably'}}, 'adverseEventsModule': {'description': 'All-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Initiate an Osteoporosis Prescription Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet'}, {'id': 'OG001', 'title': 'Usual Care'}], 'classes': [{'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post-intervention', 'description': 'We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Intent-to-Treat Analysis the data was imputed for non-responders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reported Use of Calcium and Vitamin D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet'}, {'id': 'OG001', 'title': 'Usual Care'}], 'classes': [{'title': 'Vitamin D (6 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '554', 'groupId': 'OG000'}, {'value': '562', 'groupId': 'OG001'}]}]}, {'title': 'Calcium (6 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '427', 'groupId': 'OG000'}, {'value': '437', 'groupId': 'OG001'}]}]}, {'title': 'Vitamin D (18 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1178', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '475', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}]}]}, {'title': 'Calcium (18 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1178', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '249', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 18 months post-intervention', 'description': 'We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Intent-to-Treat Analysis the data was imputed for non-responders.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet'}, {'id': 'OG001', 'title': 'Usual Care'}], 'classes': [{'title': 'BMD (6 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '469', 'groupId': 'OG000'}, {'value': '469', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '290', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}]}, {'title': 'BMD (18 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'OG000'}, {'value': '663', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '530', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 18 months post-intervention', 'description': 'Self-report of a receipt of a DXA scan (Bone Mineral Density test).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Intent-to-Treat Analysis the data was imputed for non-responders. Surveys for BMD (18 months) included 3 responses. If participants marked option (2) that they had received a BMD, but \\> 12 months ago they were excluded from analyses. Thus our overall population analyzed (those marking response 1 or 3) is different than our participant flow.'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Initiate an Osteoporosis Prescription Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1178', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet'}, {'id': 'OG001', 'title': 'Usual Care'}], 'classes': [{'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '18 months', 'description': 'We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1342', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet'}, {'id': 'OG001', 'title': 'Usual Care'}], 'classes': [{'title': 'Bone health discussion w/provider (6 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'OG000'}, {'value': '1342', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '583', 'groupId': 'OG000'}, {'value': '573', 'groupId': 'OG001'}]}]}, {'title': 'Bone health discussion w/provider (18 months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1178', 'groupId': 'OG000'}, {'value': '1250', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '779', 'groupId': 'OG000'}, {'value': '806', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 and 18 months post-intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'For the Intent-to-Treat Analysis the data was imputed for non-responders.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet'}, {'id': 'FG001', 'title': 'Usual Care'}], 'periods': [{'title': '6 Month Outcome Measures Post-interventi', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1342'}, {'groupId': 'FG001', 'numSubjects': '1342'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '953'}, {'groupId': 'FG001', 'numSubjects': '1053'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}, {'groupId': 'FG001', 'numSubjects': '289'}]}]}, {'title': '18 Month Outcome Measures Post-intervent', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1178'}, {'groupId': 'FG001', 'numSubjects': '1250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '859'}, {'groupId': 'FG001', 'numSubjects': '970'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '319'}, {'groupId': 'FG001', 'numSubjects': '280'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Video-based Intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.\n\nVideo-based Intervention: Video clips delivered by DVD and Internet'}, {'id': 'BG001', 'title': 'Usual Care'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.9', 'spread': '8', 'groupId': 'BG000'}, {'value': '74.9', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '74.9', 'spread': '7.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1317', 'groupId': 'BG000'}, {'value': '1321', 'groupId': 'BG001'}, {'value': '2638', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1247', 'groupId': 'BG000'}, {'value': '1239', 'groupId': 'BG001'}, {'value': '2486', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1342', 'groupId': 'BG000'}, {'value': '1342', 'groupId': 'BG001'}, {'value': '2684', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Participants who Completed Barriers to Osteoporosis Treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1342', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '482', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '482', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "A list of seven potentially modifiable barriers was presented to patients in the baseline survey. Those that ranked them in the intervention arm (N=482) were allocated a tailored online and video intervention based on their response. Unfortunately, not all participants ranked barriers (i.e., they didn't follow the survey directions). Individuals that did not rank barriers received an intervention corresponding to the next level of tailoring (e.g., Responses on the Patient's Views about Osteoporosis Use and Therapy Scale, Readiness to Behavior Change, or Osteoporosis treatment history).", 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.'}, {'title': "Number of Participants who completed Patient's Views about Osteoporosis and Use of Therapy Scale", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1342', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '429', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '429', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients in the "Video-based intervention" arm that didn\'t rank barriers, but who did complete the Patient\'s Views about Osteoporosis and Use of Therapy Scale (N=429) received a tailored intervention based on responses to this scale. Unfortunately, not all participants completed the Patient\'s Views about Osteoporosis and Use of Therapy Scale (i.e., they didn\'t follow the survey directions); these individuals received an intervention corresponding to the next level of tailoring (e.g., Readiness to Behavior Change, or Osteoporosis treatment history).', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.'}, {'title': 'Number of Participants who Completed Readiness to Behavior Change', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1342', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '300', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients in the "Video-based intervention" arm that didn\'t rank barriers,and did not complete the Patient\'s Views about Osteoporosis and Use of Therapy Scale received a tailored intervention based on their readiness to behavior change (N=300) as assessed by a modified version of Weinstein\'s Precaution Adoption Process Model. Unfortunately, not all participants completed the Readiness to Behavior Change (i.e., they didn\'t follow the survey directions); these individuals received an intervention corresponding to the next level of tailoring (e.g., Osteoporosis treatment history).', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.'}, {'title': 'Number of Participants who Completed the Osteoporosis Treatment History (tailoring)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1342', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1342', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Patients in the "Video-based intervention" arm that didn\'t rank barriers, did not complete the Patient\'s Views about Osteoporosis and Use of Therapy Scale, and where readiness to behavior change could not be assessed received an intervention tailored based on their osteoporosis treatment history as assessed by our survey (N=131). The categorization for this variable was dichotomous, those that indicated they had received previous treatment or those that indicated they had not received previous treatment.', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data were only evaluated for intervention tailoring on the "Video-based intervention" arm. "Usual care" data on this measure was not evaluated for the purposes of tailoring, therefore the Row population consists only of the intervention arm (n=1342) and does not include usual care. This results in the row population differing from overall.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2684}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2013-07-11', 'resultsFirstSubmitDate': '2018-03-09', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-29', 'studyFirstPostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Who Reported Communicating With a Health Care Provider About Osteoporosis Care', 'timeFrame': '6 and 18 months post-intervention'}], 'primaryOutcomes': [{'measure': 'Number of Participants That Initiate an Osteoporosis Prescription Medication', 'timeFrame': '6 months post-intervention', 'description': 'We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the primary outcome.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Reported Use of Calcium and Vitamin D', 'timeFrame': '6 and 18 months post-intervention', 'description': 'We will assess the use of calcium and vitamin D by participant. This will be assessed on a self-completed survey. Participants will be asked if they are currently taking a calcium supplement and/or vitamin D supplement.'}, {'measure': 'Number of Participants Who Reported Receipt of Bone Mineral Density (BMD) Testing', 'timeFrame': '6 and 18 months post-intervention', 'description': 'Self-report of a receipt of a DXA scan (Bone Mineral Density test).'}, {'measure': 'Number of Participants That Initiate an Osteoporosis Prescription Medication', 'timeFrame': '18 months', 'description': 'We will assess the number of participants that self-report the initiation of an osteoporosis prescription medication. It will be assessed using a self-completed survey. Osteoporosis prescription medications that will be assessed include: alendronate, calcitonin, denosumab ibandronate, raloxifene, risedronate, teriparatide, and zoledronic acid. We will not include initiation of estrogen hormone therapies as part of the outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoporosis']}, 'referencesModule': {'references': [{'pmid': '18787907', 'type': 'BACKGROUND', 'citation': 'Yood RA, Mazor KM, Andrade SE, Emani S, Chan W, Kahler KH. Patient decision to initiate therapy for osteoporosis: the influence of knowledge and beliefs. J Gen Intern Med. 2008 Nov;23(11):1815-21. doi: 10.1007/s11606-008-0772-0. Epub 2008 Sep 12.'}, {'pmid': '3049068', 'type': 'BACKGROUND', 'citation': 'Weinstein ND. The precaution adoption process. Health Psychol. 1988;7(4):355-86. doi: 10.1037//0278-6133.7.4.355.'}, {'pmid': '27453960', 'type': 'RESULT', 'citation': 'Danila MI, Outman RC, Rahn EJ, Mudano AS, Thomas TF, Redden DT, Allison JJ, Anderson FA, Anderson JP, Cram PM, Curtis JR, Fraenkel L, Greenspan SL, LaCroix AZ, Majumdar SR, Miller MJ, Nieves JW, Safford MM, Silverman SL, Siris ES, Solomon DH, Warriner AH, Watts NB, Yood RA, Saag KG. A multi-modal intervention for Activating Patients at Risk for Osteoporosis (APROPOS): Rationale, design, and uptake of online study intervention material. Contemp Clin Trials Commun. 2016 Dec 15;4:14-24. doi: 10.1016/j.conctc.2016.06.010.'}, {'pmid': '29377378', 'type': 'RESULT', 'citation': 'Danila MI, Outman RC, Rahn EJ, Mudano AS, Redden DT, Li P, Allison JJ, Anderson FA, Wyman A, Greenspan SL, LaCroix AZ, Nieves JW, Silverman SL, Siris ES, Watts NB, Miller MJ, Curtis JR, Warriner AH, Wright NC, Saag KG. Evaluation of a Multimodal, Direct-to-Patient Educational Intervention Targeting Barriers to Osteoporosis Care: A Randomized Clinical Trial. J Bone Miner Res. 2018 May;33(5):763-772. doi: 10.1002/jbmr.3395. Epub 2018 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a randomized trial of a tailored intervention designed to provide personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and digital video discs (DVDs). The content will be uniquely tailored to each person based on barriers to care, age and race/ethnicity. We will conduct a controlled, cluster-randomized trial of this intervention to determine differences in post-intervention rates of osteoporosis care between two randomization arms.\n\nWe hypothesize that participants randomized to the intervention arm, compared to those randomized to a control arm, will receive more osteoporosis care at 6 months post-intervention, as evidenced by higher rates of: (H1) Prescription osteoporosis therapies, (H2) Non-prescription therapy with calcium and vitamin D, and (H3) Bone mineral density (BMD) testing.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported history of fracture\n\nExclusion Criteria:\n\n* Self-reported current prescription osteoporosis treatment'}, 'identificationModule': {'nctId': 'NCT01907269', 'acronym': 'APROPOS', 'briefTitle': 'A Direct-to-patient Intervention to Increase Rates of Osteoporosis Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Activating Patients to Reduce OsteoPOrosiS', 'orgStudyIdInfo': {'id': 'X110928001'}, 'secondaryIdInfos': [{'id': 'R01AR060240', 'link': 'https://reporter.nih.gov/quickSearch/R01AR060240', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video-based intervention', 'description': 'Video-based intervention providing personalized feedback regarding patients\' risk of subsequent fractures, customized information regarding osteoporosis care, and messaging to activate patients to become more engaged in improving osteoporosis treatment and doctor-patient communication. This novel content will use "story-telling" delivered via the Internet and DVDs. The content will be uniquely tailored to each person based on their reported barriers to care, age and race/ethnicity. The video-based intervention materials will be augmented by a personal phone call and interactive voice response messaging.', 'interventionNames': ['Behavioral: Video-based Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care'}], 'interventions': [{'name': 'Video-based Intervention', 'type': 'BEHAVIORAL', 'description': 'Video clips delivered by DVD and Internet', 'armGroupLabels': ['Video-based intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts at Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Jewish Hospital of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Group Health Research Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Kenneth G Saag, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}, {'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}, {'name': 'Helen Hayes Hospital', 'class': 'OTHER'}, {'name': 'Kaiser Permanente', 'class': 'OTHER'}, {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, {'name': 'University of Pittsburgh', 'class': 'OTHER'}, {'name': 'University of Cincinnati', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Kenneth Saag, MD, MSc', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}