Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-01-25 @ 7:39 AM
Study NCT ID:
NCT06579534
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimedia Education for Frail Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Fall prevention education before discharge is an inevitable measure. Participants accepted such measures but did not know that this study involved differentiated health education methods.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control and Experimental group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2024-07-27', 'studyFirstSubmitQcDate': '2024-08-28', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inpatients' knowledge of fall risk in acute medical institutions', 'timeFrame': 'discharge day (assessed up to 1 days)', 'description': 'Fall Risk Assessment Scale:\n\nKnowledge related to fall risk is a self-compiled questionnaire with a total of 5 questions. The estimated test time is 3 to 5 minutes.\n\nAnswer with true or false questions, each question is worth 20 points, and the score ranges from 0 to 100 points.\n\nThe higher the score, the better the knowledge level.'}, {'measure': 'inpatients' knowledge of fall management in acute medical institutions', 'timeFrame': 'discharge day (assessed up to 1 days)', 'description': 'Fall Prevention Self-health Management Scale:\n\nThe knowledge related to fall prevention and self-health management is a self-constructed questionnaire with a total of 5 questions. The estimated test time is 3 to 5 minutes.\n\nAnswer with true or false questions, each question is worth 20 points, and the score ranges from 0 to 100 points.\n\nThe higher the score, the better the knowledge level.'}, {'measure': 'inpatients' knowledge of fall prevention in acute medical institutions', 'timeFrame': 'discharge day (assessed up to 1 days)', 'description': 'Fall Prevention Scale Knowledge related to fall prevention is a self-constructed questionnaire with a total of 5 questions.\n\nAnswer with true or false questions, each question is worth 20 points, and the score ranges from 0 to 100 points.\n\nThe higher the score, the better the knowledge level.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fall', 'Frailty', 'Multimedia Health Education'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to explore the impact of precision health care interventions on inpatients in acute medical institutions regarding their risk of falls, management, and prevention knowledge, as well as the incidence of falls among these patients. The main questions it aims to answer are:\n\nWhat is the effectiveness of precision health care interventions on inpatients' knowledge of fall risk in acute medical institutions? What is the effectiveness of precision health care interventions on inpatients' knowledge of fall management in acute medical institutions? What is the effectiveness of precision health care interventions on inpatients' knowledge of fall prevention in acute medical institutions?", 'detailedDescription': 'Frailty relates to the concept of physical deterioration associated with the aging process, which includes a weakening of the physiological and integrated physical strength of the body, its reserve and resistance to stressors, resulting in poor health, such as loss of physical and mental performance. Frailty is an important health care topic in patients with geriatric syndromes. Once the elderly enter the early stage of frailty, they are likely to fall repeatedly. Studies have shown that frailty and premature aging are important predictors of falls in the elderly. Therefore, professional medical staff should use frailty assessment indicators as early as possible to assess the possibility of frailty among the elderly in medical institutions or communities. At the same time, effective prevention strategies should be adopted to prevent reduce the incidence of falls due to frailty and improve the quality of life of patients and the elderly. Therefore, assessment of possible falls and frailty risks is a priority in acute care settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients admitted to general acute wards and surgical patients\n2. Fall assessment score ≥ 3% of the high-risk group for falls\n\nExclusion Criteria:\n\n1. Patients who were bedridden for a long time before admission\n2. Patients suffering from mental illness\n3. The patient or primary caregiver cannot respond effectively'}, 'identificationModule': {'nctId': 'NCT06579534', 'briefTitle': 'Multimedia Education for Frail Patients', 'organization': {'class': 'OTHER', 'fullName': 'Asia University'}, 'officialTitle': 'Exploring the Effectiveness of Multimedia Health Education Guidance on Risk Perception, Self-Health Management, and Fall Prevention Among Frail Patients', 'orgStudyIdInfo': {'id': 'AsiaU1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Device: Oral Explanation of Paper-Based Health Education', 'description': 'Before the patient is discharged from the hospital, the nurse orally informs the patient about the precautions for preventing falls after discharge using a discharge health education leaflet.'}, {'type': 'EXPERIMENTAL', 'label': 'Device: Multimedia Video Health Education on Fall Prevention', 'description': 'Multimedia audio-visual health education tools: Taking fall risk factors, self-health management and fall prevention measures as the main teaching plan, investigators produce multimedia digital audio-visual teaching materials in Chinese version for adults, Chinese version for children, and English version for adults, with built-in AI patented artificial intelligence automatic dubbing, and matching Chinese or English subtitles and lively 3D virtual lecturers are presented on the screen to explain the course, and pictures, physical photos, short videos, etc. are used as the main content, allowing viewers to quickly and conveniently grasp the key points and absorb knowledge.', 'interventionNames': ['Other: Health education strategy']}], 'interventions': [{'name': 'Health education strategy', 'type': 'OTHER', 'description': 'Based on the concept of precise health care, investigators design risk awareness, self-health management and fall prevention care measures, and provide inpatients with high-risk groups with frailty and falls with health education guidance on muscle endurance training and fall prevention. This study adopts purposive sampling, randomization, assignment, and parallel experiments to divide into a control group and an experimental group. The control group uses conventional health education guidance to provide fall prevention education, and the experimental group uses multimedia health education videos to provide education to patients or primary caregivers. Provide health education on the risk, management and prevention of falls.', 'armGroupLabels': ['Device: Multimedia Video Health Education on Fall Prevention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Wen-Yi Chao', 'role': 'CONTACT', 'email': 'wenyichao99@gmail.com', 'phone': '0932934340'}], 'overallOfficials': [{'name': 'Hua-Shan Wu', 'role': 'STUDY_CHAIR', 'affiliation': 'Asia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}