Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-30 @ 4:08 AM
Study NCT ID:
NCT01552551
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2012-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D009038', 'term': 'Motion'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 189}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-03-12', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Falls', 'timeFrame': '6 months', 'description': 'Falls ascertained in automated monthly telephone contact'}], 'secondaryOutcomes': [{'measure': 'Fall-related injuries requiring hospitalization/emergency department care', 'timeFrame': '6 months', 'description': 'Events ascertained in a monthly automated telephone interview'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Falls', 'exercise', 'safety', 'injury', 'Older adults'], 'conditions': ['Lower Extremity Weakness Distal', 'Distorted; Balance']}, 'descriptionModule': {'briefSummary': 'Older adults at high risk of falls will complete the PA Healthy Steps program. This program will be implemented by research staff who will follow the training manual and implement the program as it was designed to assess the effectiveness of the program. Participants will then be randomly assigned to three arms: (i) Follow-up only; (ii) Falls case management, in which adherence to physician and home safety assessments will be facilitated; and (iii) Healthy Steps in Motion, a 4-week group exercise program designed to complement Healthy Steps. All participants will be followed monthly for 6 months through personal and automated telephone interview protocols to ascertain falls and injuries.', 'detailedDescription': 'This falls prevention program is offered in 11 senior housing sites. Trained instructors from the research team provide the Healthy Steps in Motion exercise classes. Participants provide a signed form indicating physician clearance for participation. Falls case management involves monthly calls to speak with participants about home safety checks, perceived risk for falls, and physician contact or other visits to health care professionals to reduce falls risk.\n\nThis study is a pilot. The research team is interested in participation and adherence, as well as the primary outcome of falls incidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Willing to be randomized\n3. Scoring in the lowest tertile on at least one test in the Healthy Steps lower extremity performance battery\n4. Age 50+\n\nExclusion Criteria:\n\n1. Hospice enrollee or life-threatening illness\n2. Active cancer treatment\n3. Neurologic disease linked to falls risk, such as Parkinson's\n4. Unable to ambulate indoors\n5. High likelihood of moving in next 6 months"}, 'identificationModule': {'nctId': 'NCT01552551', 'briefTitle': 'Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Assessment and Referral Versus Exercise in Primary Prevention of Falls: PA Healthy Steps Program', 'orgStudyIdInfo': {'id': 'U48DP002657-RCT'}, 'secondaryIdInfos': [{'id': 'U48DP002657', 'link': 'https://reporter.nih.gov/quickSearch/U48DP002657', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Steps', 'description': 'Healthy Steps program as currently implemented by the PA Department of Aging', 'interventionNames': ['Behavioral: Assessment and education']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Steps with Falls Case Management', 'description': 'Healthy Steps program augmented with research interventionist guidance on seeking physician care and home safety assessment', 'interventionNames': ['Behavioral: Healthy Steps with Falls Case Management']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Steps in Motion', 'description': 'Healthy Steps program augmented with Healthy Steps in Motion, a 4-week, twice a week program of group exercise.', 'interventionNames': ['Behavioral: Healthy Steps in Motion']}], 'interventions': [{'name': 'Assessment and education', 'type': 'BEHAVIORAL', 'description': 'PA Healthy Steps program', 'armGroupLabels': ['Healthy Steps']}, {'name': 'Healthy Steps with Falls Case Management', 'type': 'BEHAVIORAL', 'description': 'Counseling to ensure that participants receive a physician assessment and home safety check', 'armGroupLabels': ['Healthy Steps with Falls Case Management']}, {'name': 'Healthy Steps in Motion', 'type': 'BEHAVIORAL', 'description': 'Group exercise program', 'armGroupLabels': ['Healthy Steps in Motion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Steven M Albert, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Deidentified research data will be made available to qualified investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Steven M. Albert', 'investigatorAffiliation': 'University of Pittsburgh'}}}}