Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-04-19 @ 10:07 PM
Study NCT ID:
NCT05198193
Status:
UNKNOWN
Last Update Posted:
2022-04-14
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation and Development of Falls Prevention and Management in the Community for Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-01-15', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'How much does the participant want to find out about preventing falls for himself/herself or his/her father/mother?', 'timeFrame': 'After being given a message during the survey, an average of 2 minutes', 'description': 'This is a scale variable ranging from 1 to 9, which is "1" if not at all and "9" if a lot'}], 'secondaryOutcomes': [{'measure': "Whether the participant or the participant's father/mother has fallen in the past 12 months", 'timeFrame': 'After being given a message during the survey, an average of 2 minutes', 'description': 'This is a categorical variable, which is "Yes" if the participant or the participant\'s father/mother has fallen in the past 12 months, "No" if not, and "Do not know" if the participant does not know whether his/her father/mother has fallen in the past 12 months'}, {'measure': "Whether the participant or the participant's father/mother is concerned about falling", 'timeFrame': 'After being given a message during the survey, an average of 2 minutes', 'description': 'This is a categorical variable, which is "Very concerned" if the participant or the participant\'s father/mother is very concerned about falling, "Slightly concerned" if s/he is slightly concerned about falling, "Not concerned" if s/he is not concerned about falling, and "Do not know" if the participant does not know whether his/her father/mother is concerned about falling'}, {'measure': "Whether the participant or the participant's father/mother feels like s/he is going to fall when standing or walking", 'timeFrame': 'After being given a message during the survey, an average of 2 minutes', 'description': 'This is a categorical variable, which is "Always" if the participant or the participant\'s father/mother always feels like s/he is going to fall when standing or walking, "Sometimes" if s/he sometimes feels like s/he is going to fall when standing or walking, "Never" if s/he never feels like s/he is going to fall when standing or walking, and "Do not know" if the participant does not know whether his/her father/mother feels like s/he is going to fall when standing or walking'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Falls Risk', 'Falls Prevention']}, 'referencesModule': {'references': [{'pmid': '21471918', 'type': 'BACKGROUND', 'citation': 'Dickinson A, Machen I, Horton K, Jain D, Maddex T, Cove J. Fall prevention in the community: what older people say they need. Br J Community Nurs. 2011 Apr;16(4):174-80. doi: 10.12968/bjcn.2011.16.4.174.'}, {'pmid': '31188722', 'type': 'BACKGROUND', 'citation': 'Liu X, Shuster MM, Mikels JA, Stine-Morrow EAL. Doing What Makes You Happy: Health Message Framing for Younger and Older Adults. Exp Aging Res. 2019 Jul-Sep;45(4):293-305. doi: 10.1080/0361073X.2019.1627491. Epub 2019 Jun 12.'}]}, 'descriptionModule': {'briefSummary': "This study investigates how differently-framed messages can affect people's attitude towards falls risk and prevention in older adults. This study considers the potentiality of adult children acting as change agents in influencing parents in falls prevention.", 'detailedDescription': "A randomized controlled trial (RCT) will be conducted to test the effectiveness of two messaging types (positively vs negatively framed) via two target audiences (older vs younger adults).\n\nThe RCT evaluates the effectiveness of the differently-framed messages delivered to older and younger adults in affecting people's attitude toward falls risk and motivating them to learn about preventing falls. Also, the potential of adult children acting as change agents to positively influence parents in preventing falls is explored.\n\nOlder and younger adults who are eligible to participate in this study are randomly given one message. For older adults, the objective is to study which message is more effective in affecting their attitude towards falls risk and motivating them to learn about preventing falls. For younger adults, the aim is to understand which message is more effective in motivating them to learn about preventing falls for their parents.\n\nHypotheses:\n\nH1: The negatively framed message is more effective than the positively framed counterpart in motivating older adults to find out about preventing falls. However, this effect decreases as the socioeconomic status decreases.\n\nH2: The negatively framed message is more effective than the positively framed counterpart in motivating younger adults to find out about preventing falls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singaporean or Permanent Residents (PRs)\n* Read/speak English, Mandarin, or Malay\n* Either age 60 years old and above, walk independently with or without assistive devices, have no self-reported/detected dementia or cognitive impairments or age between 30 and 59 years old and have either one of the parents age 60 years old and above who walk independently with or without assistive devices\n\nExclusion Criteria:\n\n* Not Singaporean or PRs\n* Do not read/speak English, Chinese, and Malay\n* Age 29 years old and below\n* Cannot walk independently with and without assistive devices\n* Have self-reported/detected dementia or cognitive impairments'}, 'identificationModule': {'nctId': 'NCT05198193', 'briefTitle': 'Evaluation and Development of Falls Prevention and Management in the Community for Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'National University of Singapore'}, 'officialTitle': 'Evaluation and Development of Falls Prevention and Management in the Community of Central and North of Singapore for Older Adults', 'orgStudyIdInfo': {'id': 'NUS-IRB-2020-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control - Older Adults', 'description': 'Participants age 60 years old or above.', 'interventionNames': ['Behavioral: No Message Given']}, {'type': 'EXPERIMENTAL', 'label': 'Positive - Older Adults', 'description': 'Participants age 60 years old or above.', 'interventionNames': ['Behavioral: Positive Message Given - Older Adults']}, {'type': 'EXPERIMENTAL', 'label': 'Negative - Older Adults', 'description': 'Participants age 60 years old or above.', 'interventionNames': ['Behavioral: Negative Message Given - Older Adults']}, {'type': 'EXPERIMENTAL', 'label': 'Control - Younger Adults', 'description': 'Participants age between 30 and 59 years old.', 'interventionNames': ['Behavioral: No Message Given']}, {'type': 'EXPERIMENTAL', 'label': 'Positive - Younger Adults', 'description': 'Participants age between 30 and 59 years old.', 'interventionNames': ['Behavioral: Positive Message Given - Younger Adults']}, {'type': 'EXPERIMENTAL', 'label': 'Negative - Younger Adults', 'description': 'Participants age between 30 and 59 years old.', 'interventionNames': ['Behavioral: Negative Message Given - Younger Adults']}], 'interventions': [{'name': 'No Message Given', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm are not given any intervention.', 'armGroupLabels': ['Control - Older Adults', 'Control - Younger Adults']}, {'name': 'Positive Message Given - Older Adults', 'type': 'BEHAVIORAL', 'description': "Participants in this arm are given a positively framed message from an older adult's point of view.", 'armGroupLabels': ['Positive - Older Adults']}, {'name': 'Negative Message Given - Older Adults', 'type': 'BEHAVIORAL', 'description': "Participants in this arm are given a negatively framed message from an older adult's point of view.", 'armGroupLabels': ['Negative - Older Adults']}, {'name': 'Positive Message Given - Younger Adults', 'type': 'BEHAVIORAL', 'description': "Participants in this arm are given a positively framed message from an adult child's point of view.", 'armGroupLabels': ['Positive - Younger Adults']}, {'name': 'Negative Message Given - Younger Adults', 'type': 'BEHAVIORAL', 'description': "Participants in this arm are given a negatively framed message from an adult child's point of view.", 'armGroupLabels': ['Negative - Younger Adults']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Su-Chin Hsu', 'role': 'CONTACT', 'email': 'schsu@nus.edu.sg', 'phone': '+6566011672'}], 'facility': 'National University of Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Su-Chin Hsu, PhD', 'role': 'CONTACT', 'email': 'schsu@nus.edu.sg', 'phone': '+6566011672'}, {'name': 'Lianjun Li, PhD', 'role': 'CONTACT', 'email': 'lianjun.li@nus.edu.sg', 'phone': '+6566011672'}], 'overallOfficials': [{'name': 'Noah Lim, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Global Asia Institute, The National University of Singapore'}, {'name': 'Tuo-Yu Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Master Program in Global Health and Development, Taipei Medical University'}, {'name': 'Su-Chin Hsu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Global Asia Institute, The National University of Singapore'}, {'name': 'Lianjun Li, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Global Asia Institute, The National University of Singapore'}, {'name': 'Catherine Yeung, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Marketing, The Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Noah Lim', 'investigatorAffiliation': 'National University of Singapore'}}}}