Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:05 PM
Study NCT ID:
NCT07458958
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-03-19', 'size': 347831, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-03-19T03:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Certainly. Here is a concise English summary of the blinding procedures described in the study protocol.\n\nThis study employed a single-blind design. Due to the pragmatic nature of the intervention, which involved home environment assessments and the provision of physical aids, it was not feasible to blind the participating older adults or the personnel delivering the intervention. However, to minimize assessment bias, outcome assessors responsible for collecting follow-up data (e.g., fall incidents, questionnaire responses) and data analysts were blinded to the group allocation (intervention or control) throughout the trial.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Title: A Cluster Randomized Controlled Trial of Home Environment Assessment and Modification for Fall Prevention among Community-Dwelling Older Adults in Guangzhou, China\n\n1. Study Design A two-arm, parallel-group, cluster randomized controlled trial (RCT) with a 12-month follow-up period.\n2. Primary Objective To evaluate the effectiveness of a home environment assessment and modification intervention in reducing the incidence of falls among community-dwelling older adults, compared to a no-intervention control.\n3. Participants and Setting Target Population: 320 community-dwelling adults aged 60-80 years. Setting: 8 Community Health Centers (CHCs) in Huadu District, Guangzhou. Inclusion Criteria: Able to walk 50 meters unaided, planning to reside in the current address for the next 12 months.\n\n Exclusion Criteria: Acute illness, unwilling to complete the 12-month follow-up.\n4. Intervention Intervention Group: Receives a one-time, comprehensive home environment fall hazard'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of falling in each group', 'timeFrame': 'Time Frame: Baseline, 6-month, 12-month]', 'description': 'Falls will be monitored with supplied monthly fall diaries.'}], 'secondaryOutcomes': [{'measure': 'Knowledge, Attitudes, and Practices (KAP) regarding Fall Prevention', 'timeFrame': 'Time Frame: Baseline, 6-month, 12-month', 'description': 'Measuring Knowledge, Attitudes, and Practices (KAP) regarding fall using a self-administered questionnaire.\n\nRegarding the questionnaire measurement section, we would like to clarify that the Knowledge, Attitude, and Practices (KAP) survey in our study was scored and assessed as a holistic construct or a composite measure. The overall KAP score was used for primary reporting and statistical analysis, rather than treating Knowledge (K), Attitude (A), and Practices (P) as three independent, separately analyzed dimensions or subscales.'}, {'measure': 'Fall efficacy in each group', 'timeFrame': 'Time Frame: Baseline, 6-month, 12-month', 'description': 'Fall efficacy will be monitored with \'Falls Efficacy Scale International, FES-I\', and each item is scored on a scale of 1 to 4 (from "not at all confident" to "very confident"), with a total score of 16 to 64, with higher scores indicating a greater sense of fall efficacy or self-confidence.'}, {'measure': 'Quality of life in each group', 'timeFrame': 'Time Frame: Baseline, 6-month, 12-month', 'description': "Quality of life will be monitored with 'the 12-item MOS Short-form Health Survey version 2, SF-12 V.2'. All entries except 1, 8, 9 and 10 are positively scored and the total score is calculated by the scale's unique standardised method, with a minimum score of 0 and a maximum score of 100"}, {'measure': 'Timed Up and Go (TUG) Test', 'timeFrame': 'Time Frame: Baseline, 6-month, 12-month', 'description': 'Description: The Timed Up and Go (TUG) Test is a simple, performance-based assessment of functional mobility, dynamic balance, and fall risk. It measures the time (in seconds) a person takes to stand up from a standard chair, walk 3 meters at a comfortable and safe pace, turn around, walk back to the chair, and sit down again.\n\nKey Metrics:\n\nScore Range: The result is a continuous time measurement in seconds. There is no predefined minimum or maximum score, as it is a timed test.\n\nInterpretation: A higher score (longer time) indicates worse performance-specifically, greater mobility impairment, higher fall risk, and reduced functional independence.\n\nCommon Clinical Cut-off: While not a strict maximum, a time of ≥10 seconds for community-dwelling older adults is often used as a clinical indicator of potential mobility limitations and increased fall risk. Times significantly above 10-12 seconds suggest higher impairment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cost-Effectiveness Analysis', 'Home Hazard Assessment and Modification', 'RCT', 'Community-Dwelling Older Adults', 'Fall Prevention'], 'conditions': ['Fall', 'Old Age']}, 'descriptionModule': {'briefSummary': 'This Guangzhou-based project uses a randomized controlled trial to test home environment modifications (e.g., anti-slip mats, lighting) for preventing falls among 320 community-dwelling elders. Over 12 months, it assesses effectiveness, cost-efficiency, and scalability, with rigorous quality control and multi-level stakeholder collaboration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 60 and 80 years old (inclusive).\n* Community-dwelling.\n* Planning to reside at the current address for the next 12 months.\n* Able to walk 50 meters unaided (can use a cane).\n* Experienced one or more falls in the past 2 years, OR Is "very worried" or "somewhat worried" about falling (even without a fall history).\n* Willing to participate in the 12-month fall prevention program and follow-up assessments.\n* Possesses basic literacy skills (equivalent to elementary school level or above) and is capable of normal communication with the investigators, as judged by the staff.\n* In a stable health condition to participate, as determined by the investigator.\n\nExclusion Criteria:\n\n* Having an acute disease or an acute episode of a chronic disease.\n* Having hearing, vision, or cognitive impairments, or self-reported neurological or psychiatric diseases (e.g., epilepsy, dementia) that prevent normal communication and learning.\n* Self-reported serious diseases (e.g., cardiac, cerebral, renal, hepatic, respiratory, or hematologic systems) and judged by a doctor or on-site assessor as intolerant to physical activity.\n* Diagnosed with conditions that explicitly affect balance function (e.g., vestibular disorders, cerebellar system lesions, vertigo, Ménière\'s disease).\n* Requires a wheelchair or assistance from another person to walk.\n* Likely to move away from the current residence or be absent for an extended period within the next 6 months.\n* Unwilling to accept the 12-month follow-up.'}, 'identificationModule': {'nctId': 'NCT07458958', 'briefTitle': 'Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Guangzhou Center for Disease Control and Prevention'}, 'officialTitle': 'Guangzhou Community Elderly Fall Prevention Appropriate Technology Promotion Project', 'orgStudyIdInfo': {'id': 'GZCDC-ECHR-2025P0088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home Environment Assessment and Modification', 'description': 'Participants randomized to this arm receive a multi-component intervention. A trained community health worker conducts a one-time, comprehensive in-home assessment of fall hazards using a standardized checklist. Based on the assessment, the participant receives personalized, face-to-face advice for environmental modifications and is provided with, and instructed on the use of, essential safety aids including non-slip mats, night lights, anti-fall warning signs, and double-sided tape (for securing rugs). This core intervention is delivered once, 4-6 weeks after the baseline survey. All participants (in both arms) are followed up monthly for 12 months to collect data on falls.', 'interventionNames': ['Behavioral: Home Environment Assessment and Modification']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants randomized to this arm do not receive the home environment assessment, modification advice, or any safety aids. They continue with their usual activities. To ensure balanced data collection, they undergo identical baseline and outcome assessments (at 6 and 12 months) as the intervention group, and their falls are similarly tracked via monthly fall calendars for the 12-month study period.'}], 'interventions': [{'name': 'Home Environment Assessment and Modification', 'type': 'BEHAVIORAL', 'description': 'Participants randomized to this arm receive a multi-component intervention. A trained community health worker conducts a one-time, comprehensive in-home assessment of fall hazards using a standardized checklist. Based on the assessment, the participant receives personalized, face-to-face advice for environmental modifications and is provided with, and instructed on the use of, essential safety aids including non-slip mats, night lights, anti-fall warning signs, and double-sided tape (for securing rugs). This core intervention is delivered once, 4-6 weeks after the baseline survey. All participants (in both arms) are followed up monthly for 12 months to collect data on falls.', 'armGroupLabels': ['Home Environment Assessment and Modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510900', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'tingyuan huang, Phd', 'role': 'CONTACT', 'email': '41165996@qq.com', 'phone': '+8618565238524'}], 'facility': 'Guangzhoucenter Fordisease Control and Prevention（Guangzhou Health Supervision Institute）', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Run Doctor wang, Phd', 'role': 'CONTACT', 'email': 'runwang@i.smu.edu.cn', 'phone': '+8619865182576'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou Center for Disease Control and Prevention', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Southern Medical University, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}