Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT06879457
Status:
RECRUITING
Last Update Posted:
2025-09-15
First Post:
2025-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
mHealth Person-centred Self-care Support for Homebound Older Adults: A Hybrid Effectiveness-implementation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-14', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in self-efficacy assessed using the Chinese version of the General Self-Efficacy Scale', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Mean score on self-efficacy.'}, {'measure': 'Change in instrumental activities of daily living assessed using the Chinese version of the Lawton Instrumental Activities of Daily Living Scale', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Mean score on instrumental activities of daily living.'}], 'secondaryOutcomes': [{'measure': 'Change in quality of life assessed using the Chinese version of the 12-item Short Form Health Survey version 2', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Mean score on quality of life.'}, {'measure': 'Change in psychological distress assessed using the Chinese version of 21-item Depression Anxiety Stress Scale', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Mean score on psychological distress.'}, {'measure': 'Change in perceived loneliness assessed using the Chinese version of the UCLA 3-item Loneliness Scale', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Mean score on perceived loneliness.'}, {'measure': 'Change in functional mobility assessed using the Timed Up and Go Test', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Time in seconds.'}, {'measure': 'Change in sedentary behaviour assessed using the Chinese version of the Sedentary Behaviour Questionnaire for Elderly', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Mean hours per day.'}, {'measure': 'Change in frequency of healthcare utilization assessed using the self-reported healthcare utilization survey', 'timeFrame': 'At baseline, 3 months post-intervention , and 6 months post-intervention.', 'description': 'Unit of Measure: Number of visits.'}, {'measure': 'Participant reach and recruitment success measured by recruitment records', 'timeFrame': 'At baseline.', 'description': 'Unit of Measure: Percentage of eligible enrollment.'}, {'measure': 'Participant satisfaction with the intervention assessed using the Chinese version of four-dimension Client Satisfaction Questionnaire', 'timeFrame': 'At 3 months post-intervention and 6 months post-intervention.', 'description': 'Unit of Measure: Mean score on satisfaction.'}, {'measure': 'Service provider acceptability and adoption of person-centred care approach measured by focus group interview', 'timeFrame': 'At 3 months post-intervention.', 'description': 'Unit of Measure: Thematic analysis of interview records.'}, {'measure': 'Implementation fidelity and adherence to person-centred care principles measured by session recordings and fidelity checklist', 'timeFrame': 'Ongoing monitoring during intervention.', 'description': 'Unit of Measure: 1). Number and reasons for missed sessions; 2). Percentage of sessions meeting fidelity criteria.'}, {'measure': 'Long-term maintenance and retention of participants measured by cost-effectiveness analysis and retention and dropout records', 'timeFrame': 'At 6 months post-intervention.', 'description': 'Unit of Measure: 1). Incremental cost-effectiveness ratio (ICER) per additional quality adjusted life year (QALY) gained; 2). Number and reasons of dropout.'}, {'measure': 'Barriers and Facilitators to the intervention measured by focus group interview', 'timeFrame': 'At 3 months post-intervention.', 'description': 'Unit of Measure: Thematic analysis of interview records.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mobile Health', 'Person-Centred Care', 'Self-Care', 'Homebound', 'Older Adults']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the effectiveness and implementation of the mobile health (mHealth)-assisted, person-centred care (PCC) self-care support programme for homebound older adults. The researcher will compare PCC approach to a conventional care provider-led model. Participants (n = 130) will receive the intervention of six bi-weekly WhatsApp video call sessions over three months with nurse case managers (NCMs).', 'detailedDescription': 'This hybrid effectiveness-implementation, cluster-randomized controlled trial evaluates a mHealth-assisted, PCC self-care support programme for homebound older adults in Hong Kong. Participants (n = 130) receive six bi-weekly WhatsApp video call sessions with NCMs over three months. The study compares a PCC-based approach with a conventional provider-led model. Effectiveness outcomes include self-efficacy, functional independence, and psychosocial well-being. Implementation is assessed using the RE-AIM framework. Findings will inform scalable, digital health interventions for aging populations, improving functional independence, self-care engagement, and healthcare accessibility for homebound older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 60 years or older;\n* Unable to leave home more than twice per week due to physical or functional health problems;\n* Own and have basic proficiency in using a smartphone;\n* Speak Cantonese;\n* Indicate sufficient cognitive ability; and\n* Be moderately frail or below.\n\nExclusion Criteria:\n\n* Unable to hear, see, or communicate effectively;\n* Be completely bed-bound; or\n* Reside in an area without stable internet coverage.'}, 'identificationModule': {'nctId': 'NCT06879457', 'briefTitle': 'mHealth Person-centred Self-care Support for Homebound Older Adults: A Hybrid Effectiveness-implementation Study', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Empowering Homebound Older Adults in Self-care Using a Mobile Health-assisted, Person-centred Care Approach: A Hybrid Effectiveness-implementation Design', 'orgStudyIdInfo': {'id': 'HSEARS20240718004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention group emphasizes shared decision-making, goal-setting, and interdisciplinary support. The NCM will co-develop self-care plans with participants.', 'interventionNames': ['Behavioral: PCC-based mHealth-assisted self-care support intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The control group does not include shared decision-making or personalized goal-setting. Self-care plans will be developed solely by the nurse case manager (NCM).', 'interventionNames': ['Behavioral: Provider-led mHealth-assisted self-care support intervention']}], 'interventions': [{'name': 'PCC-based mHealth-assisted self-care support intervention', 'type': 'BEHAVIORAL', 'description': 'Participants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, using a person-centred care (PCC) approach.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Provider-led mHealth-assisted self-care support intervention', 'type': 'BEHAVIORAL', 'description': 'Participants receive six bi-weekly WhatsApp video call sessions with a NCM over three months, based on the conventional provider-led model.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Ricky Liu, MSc', 'role': 'CONTACT', 'phone': '+85234003805'}], 'facility': 'Yan Oi Tong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Prof. Arkers Wong', 'role': 'CONTACT', 'email': 'arkers.wong@polyu.edu.hk', 'phone': '+852 3400 3805'}], 'overallOfficials': [{'name': 'Prof. Arkers Wong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Nursing, The Hong Kong Polytechnic University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Arkers, Wong', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}