Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-31 @ 4:47 PM
Study NCT ID:
NCT04041869
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2019-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057185', 'term': 'Sedentary Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lucas-carr@uiowa.edu', 'phone': '319-353-5432', 'title': 'Lucas Carr', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.'}], 'classes': [{'categories': [{'measurements': [{'value': '6681', 'groupId': 'OG000', 'lowerLimit': '5840', 'upperLimit': '7522'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.01', 'groupDescription': 'In order to test the effect of the intervention on physical activity, linear mixed models examined changes in steps per day from study baseline (week 0) to the end of the active intervention (week 8).', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Daily steps', 'unitOfMeasure': 'Steps/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game for 8 weeks which will be visible on monitors set up in the residential facility.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'spread': '15.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "Self-efficacy was measured with the Self-Efficacy for Exercise scale, a 13-item questionnaire designed to assess participants' self-efficacy related to their ability to continue exercising in the face of barriers.", 'unitOfMeasure': 'cumulative score (0-90); higher=better', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Support', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game for 8 weeks which will be visible on monitors set up in the residential facility.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Social support for physical activity was measured with a modified version of the Social Support and Exercise Survey. The Social Support and Exercise Survey is a 12-item (originally 13 item) questionnaire that assesses the level of support from family and friends that participants have in making health behavior changes (exercise)', 'unitOfMeasure': 'mean score (0-4 range); higher=better', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Outcome Expectations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': "Outcome expectations were measured with the Outcome Expectations for Exercise Scale. The Outcome Expectations for Exercise is a valid and reliable 9-item scale that assesses the participant's outcome expectations and benefits associated with exercise.", 'unitOfMeasure': 'mean score (1-5 range) lower=better', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Social Isolation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Social isolation was measured with a modified version of the Friendship Scale. The Friendship Scale is a 5-item (originally 6-item) scale that assesses 6 dimensions contributing to social isolation', 'unitOfMeasure': 'cumulative score (4-20) higher=better', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game for 8 weeks which will be visible on monitors set up in the residential facility.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}], 'recruitmentDetails': 'Participants were recruited from June 17, 2019 to June 27, 2019, by word of mouth and through advertisements posted on digital monitors located throughout the retirement community.', 'preAssignmentDetails': 'After providing their consent to participate, participants were asked to complete a baseline survey and provided a Fitbit activity monitor to wear for a minimum of 7 days to assess their baseline physical activity.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MapTrek', 'description': 'MapTrek: Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '81.2', 'groupId': 'BG000', 'lowerLimit': '68', 'upperLimit': '92'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Physical Activity', 'classes': [{'categories': [{'measurements': [{'value': '5438', 'groupId': 'BG000', 'lowerLimit': '4620', 'upperLimit': '6256'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Steps/day', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Self-efficacy', 'classes': [{'categories': [{'measurements': [{'value': '73.2', 'spread': '14.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'cumulative score (0-90); higher=better', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Social Support', 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mean score (0-4 range; higher = better)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Outcome Expectations', 'classes': [{'categories': [{'measurements': [{'value': '4.4', 'spread': '0.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'mean score (1-5 range) lower=better', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Social Isolation', 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'spread': '2.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'cumulative score (4-20) higher=better', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-28', 'size': 1375984, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-13T16:08', 'hasProtocol': True}, {'date': '2019-09-10', 'size': 337758, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-10-13T16:46', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2019-07-30', 'resultsFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-09', 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical Activity', 'timeFrame': '8 weeks', 'description': 'Daily steps'}], 'secondaryOutcomes': [{'measure': 'Self-efficacy', 'timeFrame': '8 weeks', 'description': "Self-efficacy was measured with the Self-Efficacy for Exercise scale, a 13-item questionnaire designed to assess participants' self-efficacy related to their ability to continue exercising in the face of barriers."}, {'measure': 'Social Support', 'timeFrame': '8 weeks', 'description': 'Social support for physical activity was measured with a modified version of the Social Support and Exercise Survey. The Social Support and Exercise Survey is a 12-item (originally 13 item) questionnaire that assesses the level of support from family and friends that participants have in making health behavior changes (exercise)'}, {'measure': 'Outcome Expectations', 'timeFrame': '8 weeks', 'description': "Outcome expectations were measured with the Outcome Expectations for Exercise Scale. The Outcome Expectations for Exercise is a valid and reliable 9-item scale that assesses the participant's outcome expectations and benefits associated with exercise."}, {'measure': 'Social Isolation', 'timeFrame': '8 weeks', 'description': 'Social isolation was measured with a modified version of the Friendship Scale. The Friendship Scale is a 5-item (originally 6-item) scale that assesses 6 dimensions contributing to social isolation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Older adults', 'Walking', 'Fitbit'], 'conditions': ['Sedentary Behavior']}, 'descriptionModule': {'briefSummary': 'Older adults are a growing population, with projections to reach 83.7 million by 2050. Furthermore, older adults are the most sedentary and least physically active adult population. It is estimated that nearly 90% of older adults 65 years of age or older do not meet the recommended levels of physical activity. Evidence suggests great health benefits can be achieved for older adults who are the most sedentary, and that replacing sitting with even light intensity walking can be beneficial.\n\nThe overarching goal of the project is to develop an inexpensive and scalable tool to increase volume of physical activity in our target population, older adults living in a residential facility. MapTrek is a web-based application that allows participants to take a virtual walk in interesting locations around the world while tracking their progress against the progress of other older adults living in a retirement community. Steps are counted using a commercially available accelerometer (e.g., Fitbit), and participants see their progress overlaid on Google Maps.', 'detailedDescription': 'All participants will be provided with a Fitbit activity monitor and instructed to wear it 24 hours/day (except for bathing/swimming time) on their wrist for 12 weeks. Participants will participate in four team-based walking races, each two weeks long. Participants will view their team progress on TV monitors placed in various locations at the Oaknoll facility. The Oaknoll leadership has given the research team approval to do this at their facility. The monitors will present aggregated team data and will not report any individual data that could link back to the individual participant.\n\nAt the end of the 8 week active intervention, research team members will meet with participants at Oaknoll to administer an exit/process evaluation survey. The exit survey will ask about psychosocial predictors of physical activity as well as participants thoughts and opinions of the MapTrek game. This survey should take approximate 10-15 minutes to complete. The participants will then be asked to wear the Fitbit for four more weeks without playing MapTrek, which will act as a control condition since this is a single-arm study.\n\nThe specific aims of the study are:\n\n1. To determine the efficacy of MapTrek for improving physical activity levels of older adults living in a residential facility from baseline to 8 weeks.\n2. To determine the efficacy of MapTrek for improving psychosocial outcomes(e.g., self-efficacy, social support, outcome expectations, social isolation) among older adults living in a residential facility from baseline to 8 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be eligible, participants much be between 25 and 100 years of age, physically able to walk without limitations\n\nExclusion Criteria:\n\n* Patients with cognitive or physical limitations that prohibit walking and visual or cognitive impairments causing inability to read.'}, 'identificationModule': {'nctId': 'NCT04041869', 'briefTitle': 'Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Residential MapTrek- Increasing Physical Activity Among Older Adults in a Residential-Living', 'orgStudyIdInfo': {'id': '201904816'}, 'secondaryIdInfos': [{'id': 'UL1TR002537', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR002537', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MapTrek', 'interventionNames': ['Behavioral: MapTrek']}], 'interventions': [{'name': 'MapTrek', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.', 'armGroupLabels': ['MapTrek']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Lucas Carr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Health & Human Physiology', 'investigatorFullName': 'Lucas Carr', 'investigatorAffiliation': 'University of Iowa'}}}}