Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT06415604
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-10', 'studyFirstSubmitDate': '2024-05-10', 'studyFirstSubmitQcDate': '2024-05-10', 'lastUpdatePostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective well-being', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': 'The Chinese 5-item World Health Organization Well-Being Index'}], 'secondaryOutcomes': [{'measure': 'Frailty level', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': 'FRAIL scale'}, {'measure': 'Physical functioning', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': 'The Senior Fitness Test: It covers four dimensions, including muscle endurance, balance, flexibility, and tolerance measured by 30-sec arm-curl test, 30-sec chair-stand test, back-scratch test, chair sit-and-reach test, 8-foot up-and-go test, two-min step test'}, {'measure': 'Activities of daily living', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': 'Katz Index of Independence in Activities of Daily Living'}, {'measure': 'Instrumental activities of daily living', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': 'Lawton Instrumental Activities of Daily Living Scale'}, {'measure': 'Depressive symptoms', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': '4-item Geriatric Depression scale'}, {'measure': 'Social support', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': '10-item Duke Social Support Index'}, {'measure': 'Quality of life', 'timeFrame': 'baseline, 12 weeks post-allocation, 24 weeks post-allocation', 'description': 'EuroQol 5-Dimension 5-Level'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Subjective well-being', 'frailty', 'psychoeducation'], 'conditions': ['Frailty', 'Well-Being, Psychological']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty.\n\nThe main question it aims to answer is\n\n\\- Could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community?\n\nParticipants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different:\n\n* Intervention group: psychoeducation\n* Control group: physical health education Participants will receive three home visits for data collection. Some of participants in experimental group will receive interview for process evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) Aged 65 or older; (2) Identified as frail by the FRAIL scale (score ≥3); (3) Mentally competent as determined by the Abbreviated Mental Test (AMT ≥6); (4) Able to speak and understand Cantonese; (5) Living at home; (6) Experienced in using a smartphone (e.g., sending messages, watching videos).\n\nExclusion Criteria:\n\n(1) Have visual or hearing impairments or language barriers that may impact communication or understanding; (2) Unfit for home-based exercise, as indicated by a score of 1 or higher on the 25-item HOME-FAST, a tool for identifying home fall hazards; (3) Currently engaging in exercise for at least 150 minutes per week over the past four weeks; (4) Undergoing active psychiatric or antidepressant treatment or participating in other physical exercise or rehabilitation programs.'}, 'identificationModule': {'nctId': 'NCT06415604', 'briefTitle': 'Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effects of a Home-based Psychoeducation on Subjective Well-being for Older Adults With Frailty in the Community: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2023.585.M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Participants will receive 60-minute weekly online group-based psychoeducation sessions for 12 weeks.', 'interventionNames': ['Other: Psychoeducation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Participants will receive 60-minute weekly online group-based physical health sessions for 12 weeks.', 'interventionNames': ['Other: Attention control']}], 'interventions': [{'name': 'Psychoeducation', 'type': 'OTHER', 'description': 'The content of psychoeducation is based on "Five Ways of Well-being" which covers "Be active", "Connect", "Take Notice", "Keep learning" and "Giving".', 'armGroupLabels': ['Experimental group']}, {'name': 'Attention control', 'type': 'OTHER', 'description': 'The content of the sessions mainly focuses on physical health information, such as healthy eating, physical exercise, prevention of falls, and pain management.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'state': 'New Territories', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'An TAO', 'role': 'CONTACT', 'email': 'andersontao@link.cuhk.edu.hk', 'phone': '(+852) 39439929'}], 'facility': 'The Nethersole School of Nursing, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'An TAO', 'role': 'CONTACT', 'email': 'andersontao@link.cuhk.edu.hk', 'phone': '(852) 39439929'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TAO An', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'TAO An', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}