Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-30 @ 5:54 AM
Study NCT ID:
NCT00624806
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2008-02-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marylou.guihan@va.gov', 'phone': '708-202-2414', 'title': 'Marylou Guihan, PhD', 'organization': 'Center of Innovation for Complex Chronic Health Care'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study duration was short and the sample was small. Because we only studied subjects who received the DMP, it is unknown how many would have had skin breakdown in a comparable period without the DMP.'}}, 'adverseEventsModule': {'timeFrame': 'Enrollment to study end, 8 weeks.', 'description': 'Study-related serious and non-serious adverse events were collected/assessed, but none observed.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Daily telephone calls to remind patients of recommended behaviors\n\nDaily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.\n\nNo adverse events reported.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2', 'description': 'Weekly telephone calls to remind patients of recommended behaviors\n\nWeekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.\n\nNo adverse events reported.', 'otherNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Days of Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Daily telephone calls to remind patients of recommended behaviors\n\nDaily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Weekly telephone calls to remind patients of recommended behaviors\n\nWeekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '18'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Enrollment to study end, 8 weeks', 'description': 'Data includes the number of triggered items and types of triggers.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Days With Triggers at Certain Timeframe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'No. of Days with Triggers', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Daily telephone calls to remind patients of recommended behaviors\n\nDaily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Weekly telephone calls to remind patients of recommended behaviors\n\nWeekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.'}], 'classes': [{'title': 'Baseline Day Triggers', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Days with Triggers during Intervention', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'End of Study Day Triggers', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment to study end, 8 weeks', 'description': 'Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'No. of Days with Triggers', 'denomUnitsSelected': 'Participants'}, {'type': 'PRIMARY', 'title': 'Percent of Participant Triggering DMP Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'Total Days of Category Trigger', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1', 'description': 'Daily telephone calls to remind patients of recommended behaviors\n\nDaily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.'}, {'id': 'OG001', 'title': 'Arm 2', 'description': 'Weekly telephone calls to remind patients of recommended behaviors\n\nWeekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.'}], 'classes': [{'title': 'Daily Skin Inspection', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '23.5', 'groupId': 'OG001'}]}]}, {'title': 'Equipment Issues', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '55.9', 'groupId': 'OG001'}]}]}, {'title': 'Positioning/Pressure Reliefs/Weight Shifts', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Skin Moisture Issues', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Existing Pressure Ulcer Care', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}]}]}, {'title': 'Quality of CG Care', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Feelings of Depression', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}, {'title': 'Ongoing Problems Affecting Self-Mgmt', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '14.7', 'groupId': 'OG001'}]}]}, {'title': 'Dragging Across Surfaces', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Diabetic Comorbidities', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment to study end, 8 weeks', 'description': 'Percent of participants who triggered Disease-Management Protocol items by group.', 'unitOfMeasure': '% of participants triggering an item', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Total Days of Category Trigger', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1', 'description': 'Daily telephone calls to remind patients of recommended behaviors\n\nDaily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.'}, {'id': 'FG001', 'title': 'Arm 2', 'description': 'Weekly telephone calls to remind patients of recommended behaviors\n\nWeekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Daily Group', 'description': 'Daily telephone calls to remind patients of recommended behaviors\n\nDaily phone group: Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.'}, {'id': 'BG001', 'title': 'Weekly Group', 'description': 'Weekly telephone calls to remind patients of recommended behaviors\n\nWeekly phone group: Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '12.64', 'groupId': 'BG000'}, {'value': '49.75', 'spread': '14.89', 'groupId': 'BG001'}, {'value': '50.67', 'spread': '13.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Marital status', 'classes': [{'title': 'Divorced', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Never married', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Married', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Widowed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Residence type', 'classes': [{'title': 'House', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Apartment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Education', 'classes': [{'title': 'High school graduate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Some high school', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Some college', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'College graduate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Graduate school', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current employment status', 'classes': [{'title': 'Not working', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Small business owner', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Years Since Employment', 'classes': [{'categories': [{'measurements': [{'value': '10.43', 'groupId': 'BG000', 'lowerLimit': '0.27', 'upperLimit': '31.2'}, {'value': '14.64', 'groupId': 'BG001', 'lowerLimit': '7.42', 'upperLimit': '26.3'}, {'value': '12.12', 'groupId': 'BG002', 'lowerLimit': '0.27', 'upperLimit': '31.2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Past Work History', 'classes': [{'title': 'Semi-skilled worker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Never worked', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Unskilled worker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Skilled manual worker, crafstman', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Clerical, sales worker', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Administrator, professional, manager', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of Injury in years', 'classes': [{'categories': [{'measurements': [{'value': '17.94', 'groupId': 'BG000', 'lowerLimit': '.98', 'upperLimit': '28.34'}, {'value': '18.81', 'groupId': 'BG001', 'lowerLimit': '6.4', 'upperLimit': '53'}, {'value': '18.4', 'groupId': 'BG002', 'lowerLimit': '.98', 'upperLimit': '53'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Spinal Cord Injury (SCI) Etiology', 'classes': [{'title': 'Vehicular accident', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Diving', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Fall', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Gunshot wound', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other etiology', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Level of Injury', 'classes': [{'title': 'Cervical', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Thoracic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Lumbar', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'N/A', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'American Spinal Injury Association (ASIA) Score', 'classes': [{'title': 'A = Complete', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'B = Sensory Incomplete', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'C = Motor Incomplete', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'D = Motor Incomplete', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Urinary Management', 'classes': [{'title': 'Intermittent Catheter', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Condom Catheter', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Amputees', 'classes': [{'title': 'Right Lower Extremity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'N/A', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Receive regular assistance from:', 'classes': [{'title': 'Spouse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Paid Attendant', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Partner/Significant Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other Relatives', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of prior pressure ulcers (PrU)', 'classes': [{'categories': [{'measurements': [{'value': '2.43', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '1.7', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pressure ulcers', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prior Ulcer Locations', 'classes': [{'title': 'Ischium', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Trochanter', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Sacrum', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Coccyx', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Heel', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Lateral Malleolus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Medial Malleolus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'It is possible for participants to have \\>1 ulcer, in multiple locations.', 'unitOfMeasure': 'pressure ulcers'}, {'title': 'Number of Prior Pressure Ulcer Surgeries', 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.63', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0.61', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'surgeries', 'dispersionType': 'FULL_RANGE'}, {'title': 'Prior Ulcer Surgery Locations', 'classes': [{'title': 'Ischium', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Trochanter', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Sacrum', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Coccyx', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Lateral Malleolus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'N/A', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Number of Current Pressure Ulcers', 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '6'}, {'value': '0.5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0.89', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '6'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pressure ulcers', 'dispersionType': 'FULL_RANGE'}, {'title': 'Current Pressure Ulcer Location', 'classes': [{'title': 'Ischium', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Sacrum', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'N/A', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Pressure Ulcer Stage', 'classes': [{'title': 'Stage I = Intact skin/non-blanchable redness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Stage II = Partial thickness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Stage III = Full thickness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Stage IV = Full thickness', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'N/A', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Self-Reported Skin Behaviors', 'classes': [{'title': 'Daily Skin Inspection', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Good Nutrition', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Pressure releases/Tilts/Weight shifts', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Hygiene', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Appropriate Cushion', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Safety in transfers', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'No tight clothing/shoes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Keep skin clean and dry', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2008-02-14', 'resultsFirstSubmitDate': '2014-07-25', 'studyFirstSubmitQcDate': '2008-02-25', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-26', 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of Data', 'timeFrame': 'Enrollment to study end, 8 weeks', 'description': 'Data includes the number of triggered items and types of triggers.'}, {'measure': 'Number of Days With Triggers at Certain Timeframe', 'timeFrame': 'Enrollment to study end, 8 weeks', 'description': 'Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.'}, {'measure': 'Percent of Participant Triggering DMP Items', 'timeFrame': 'Enrollment to study end, 8 weeks', 'description': 'Percent of participants who triggered Disease-Management Protocol items by group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pressure ulcer', 'Telemedicine'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '21756573', 'type': 'RESULT', 'citation': "Woo C, Guihan M, Frick C, Gill CM, Ho CH. What's happening now! Telehealth management of spinal cord injury/disorders. J Spinal Cord Med. 2011;34(3):322-31. doi: 10.1179/2045772311Y.0000000003."}]}, 'descriptionModule': {'briefSummary': "The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).", 'detailedDescription': "Background:\n\nVHA is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).\n\nObjectives:\n\nThe goal of the study was to complete activities necessary in preparation for implementing a Home Telehealth program to manage veterans with SCI/D at risk of developing PrUs. Specifically this Rapid Response Project (RRP) included: 1) Convening an expert panel to validate Pressure Ulcer (PrU) PrU DMP items; 2) Developing a standardized protocol that specified how the nurse Care Coordinator who would manage patients who develop open skin wounds across the Hub and Spoke system of care; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Developing an instrument to assess staff satisfaction with this method of patient management.\n\nMethods:\n\nA convenience sample of veterans about to be discharged home from the Cleveland SCI/D inpatient unit were asked to participate in the study. This included patients living close to the Hub and those referred from spoke sites. Subjects were randomly assigned to receive either daily calls (5 days/week) for 40 total calls, or weekly calls (8 total calls) over the course of the 8 week/2month study intervention period.\n\nStatus:\n\nThe project team is conducting ongoing analysis of the data to develop publications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic\n\nExclusion Criteria:\n\n* No phone\n* Cognitive impairment\n* Hearing impairment'}, 'identificationModule': {'nctId': 'NCT00624806', 'briefTitle': 'Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D', 'orgStudyIdInfo': {'id': 'RRP 07-292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily telephone calls', 'description': 'Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers', 'interventionNames': ['Behavioral: Daily telephone calls']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Weekly telephone calls', 'description': 'Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.', 'interventionNames': ['Behavioral: Weekly telephone calls']}], 'interventions': [{'name': 'Daily telephone calls', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.', 'armGroupLabels': ['Daily telephone calls']}, {'name': 'Weekly telephone calls', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.', 'armGroupLabels': ['Weekly telephone calls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60141-5000', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Edward Hines Jr. VA Hospital, Hines, IL', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Louis Stokes VA Medical Center, Cleveland, OH', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Marylou Guihan, PhD MA BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward Hines Jr. VA Hospital, Hines, IL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}