Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-27 @ 1:15 AM
Study NCT ID:
NCT04346303
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2020-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applying Short-term Interactive Video Games on Community Patients With Mental Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2020-03-31', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form)', 'timeFrame': '5 Weeks', 'description': "After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life."}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': '5 Weeks', 'description': 'Measuring height and weight'}, {'measure': 'Waist-hip ratio', 'timeFrame': '5 Weeks', 'description': 'Measuring the ratio of waist to hip'}, {'measure': '10-m walking time at comfortable', 'timeFrame': '5 Weeks', 'description': 'Measuring the 10-m walking time at comfortable'}, {'measure': '10-m walking time at maximum', 'timeFrame': '5 Weeks', 'description': 'Measuring the 10-m walking time at maximum'}, {'measure': 'Get Up and Go test', 'timeFrame': '5 Weeks', 'description': 'Measuring the Get Up and Go test'}, {'measure': '5 times sit-to-stand test', 'timeFrame': '5 Weeks', 'description': 'Measuring the 5 times sit-to-stand test'}, {'measure': 'Hierarchy of the Care Required', 'timeFrame': '5 Weeks', 'description': "This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function."}, {'measure': 'CHQ-12 (Chinese Health Questionnaire)', 'timeFrame': '5 Weeks', 'description': "This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms."}, {'measure': 'Short FES-I (Chinese version of the Falls Efficacy Scale )', 'timeFrame': '5 Weeks', 'description': "This is a 7-item scale to assess patient's vulnerability to fall."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Short-term Interactive Video Games', 'Community Patients with Mental Disorders'], 'conditions': ['Psychiatry', 'Nursing']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:\n\n1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.\n2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).\n3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.', 'detailedDescription': "The purpose of this study is to design prospective experiments before and after the test. The purpose is to explore whether short-term interactive video games can improve the motivation, interpersonal interaction, and physical and mental health of patients with mental illness in community rehabilitation homes. Samples of mentally ill patients from community rehabilitation homes (full-day rehabilitation institutions) in the northern region were collected using a structured questionnaire for the recipients, as follows:\n\n1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.\n2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).\n3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.\n\nPrimary Outcome Measure:\n\nThe changes of quality of life (WHOQOL-BREF: WHO Quality of Life: Brief form) After Short-term Interactive Video Games the changes of quality of life. This is a 28-items quality of life measurement to assess patient's quality of life.\n\n\\[Time Frame: 5 Weeks\\]\n\nSecondary Outcome Measures:\n\nBody Mass Index Measuring height and weight \\[Time Frame: 5 Weeks\\]\n\nWaist-hip ratio Measuring the ratio of waist to hip \\[Time Frame: 5 Weeks\\]\n\n10-m walking time at comfortable Measuring the 10-m walking time at comfortable \\[Time Frame: 5 Weeks\\]\n\n10-m walking time at maximum Measuring the 10-m walking time at maximum \\[Time Frame: 5 Weeks\\]\n\nGet Up and Go test Measuring the Get Up and Go test \\[Time Frame: 5 Weeks\\]\n\n5 times sit-to-stand test Measuring the 5 times sit-to-stand test \\[Time Frame: 5 Weeks\\]\n\nHierarchy of the Care Required This is a 18-item questionnaire to assess the patient's ADL and IADL as well as daily function.\n\n\\[Time Frame: 5 Weeks\\]\n\nCHQ-12 (Chinese Health Questionnaire) This is a 12-item scale to assess the patient's life stress indicating anxiety and depression symptoms.\n\n\\[Time Frame: 5 Weeks\\]\n\nShort FES-I (Chinese version of the Falls Efficacy Scale ) This is a 7-item scale to assess patient's vulnerability to fall. \\[Time Frame: 5 Weeks\\]"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The diagnosis conforms to the international classification standards for the diagnosis of dysphoria or bipolar disorder.\n* Be older than 20 years old.\n* those who have a clear sense and can communicate.\n* You can read the instructions carefully, and after you explain, you are willing to participate in the research plan and fill out the consent form.\n* The judges of the researchers can independently answer the interview questionnaires of this research and perform short-term interactive video game players.\n* At present, you can go out, make friends, take care of yourself, and fully exercise your rights. You have the full capacity of an adult and have not been restricted by any laws. Therefore, you do not need to obtain an additional legal agent to participate in this study Sign the consent form.\n\nExclusion Criteria:\n\n* People with difficulties in cognitive understanding, such as those who cannot communicate or suffer from cognitive impairments, such as Alzheimer's disease.\n* Those who have obvious obstacles to the physical function of their limbs, who are unable to participate in sports video games.\n* Slow development or lack of moderate intelligence may affect the understanding of interviews or participation in activities.\n* The physical and mental condition has been unstable in the past two weeks, such as instability of vital signs or obvious impaired sense of reality, obvious symptoms of delusions or hallucinations, etc., cannot be interviewed or coordinated with activities."}, 'identificationModule': {'nctId': 'NCT04346303', 'briefTitle': 'Applying Short-term Interactive Video Games on Community Patients With Mental Disorders', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Intervention Feasibility and Outcomes Evaluation of Applying Short-term Interactive Video Games on Community Patients With Mental Disorders', 'orgStudyIdInfo': {'id': '202001106RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Short-term Interactive Video Games', 'description': 'Short-term video games will be applied to patients with mental illness who are staying in communities. Games will be applied in a group-activity format with 8 to 12 patients in each session. The interventions will be conducted at a two sessions per week for a 3-week long period. There are 3 time points for data collection, including 2-weeks before the intervention, the week before the intervention, and the week after the intervention. Each patient will be his/her own controlled comparison.', 'interventionNames': ['Other: Short-term Interactive Video Games']}], 'interventions': [{'name': 'Short-term Interactive Video Games', 'type': 'OTHER', 'description': '1. Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.\n2. Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).\n3. After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity.', 'armGroupLabels': ['Short-term Interactive Video Games']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chang Jung-Chen, PhD', 'role': 'CONTACT', 'email': 'jungchenchang@ntu.edu.tw', 'phone': '(02) 223123456', 'phoneExt': '88905'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Chang Jung-Chen, PhD', 'role': 'CONTACT', 'email': 'jungchenchang@ntu.edu.tw', 'phone': '(02)223123456', 'phoneExt': '88905'}, {'name': 'Hsu Fang-Chi, University', 'role': 'CONTACT', 'email': 'r06426011@ntu.edu.tw', 'phone': '(02)223123456', 'phoneExt': '88905'}], 'overallOfficials': [{'name': 'Chang Jung-Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}