Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-25 @ 5:18 PM
Study NCT ID:
NCT05269303
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2022-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Wearable Monitoring Device in Daily Lives of Community-dwelling Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-20', 'studyFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2022-03-03', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of use intention of wearable monitoring device', 'timeFrame': 'Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points', 'description': 'It will be measured using a 4-item, 5-point Likert scale adopted from Bhattacherjee (2001) and Windasari et al. (2021). The five-point scale ranges from 1 = not at all satisfied to 5 = very certain, with higher scores representing a higher chance of continuing to use the WMD.'}], 'secondaryOutcomes': [{'measure': 'The change of adherence rate of wearing wearable monitoring device', 'timeFrame': 'Data collection will be conducted at the 1-month (T1), 3-month (T2), and 6-month (T3) time points', 'description': 'It will be measured by checking in our database the number of days that participants wore their device, and the average amount of time worn per day. Longer time worn represents better adherence rate'}, {'measure': 'The change in quality of life among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points', 'timeFrame': 'baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points', 'description': 'Quality of life will be measured using the Hong Kong version of the EuroQol 5-dimension scale. The EQ-5D-5L is comprised of five dimensions, namely, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. The utility score ranges from 0 to 1, with higher means better quality of life'}, {'measure': 'The change of health service utilization among baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points', 'timeFrame': 'baseline (T0) and at the 1-month (T1), 3-month (T2), and 6-month (T3) time points', 'description': "ealth service utilization includes the number of attendances at a general practitioner's office, emergency department, hospital, and general out-patient clinic. The data will be reported by the participants and confirmed with medical and attendance certificates"}, {'measure': 'Recruitment rate', 'timeFrame': 'baseline pre-intervention', 'description': 'The recruitment rate will be calculated by dividing the number of participants who are recruited and randomized, by the number of eligible participants.'}, {'measure': 'Attrition rate', 'timeFrame': '6-month (T3) time points', 'description': 'The attrition rate refers to the number of participants who withdraw from the study or who are lost to follow up.'}, {'measure': 'Incidence of reports of adverse events', 'timeFrame': '6-month (T3) time points', 'description': 'the incidence of reports of adverse events will be recorded by a staff member assigned to each of the community centres and a nurse'}, {'measure': 'Incidence of reports of technical difficulties', 'timeFrame': '6-month (T3) time points', 'description': 'Incidence of reports of technical difficulties will be recorded by a staff member assigned to each of the community centres and a nurse'}, {'measure': 'The change of perceived usability of the wearable monitoring device before and after the program', 'timeFrame': 'baseline pre-intervention, 6-month (T3) time points', 'description': 'The participants will be required to complete a questionnaire that measures their attitude towards using the WMD; the perceived usefulness, perceived ease of use, and self-efficacy of using the device; and their level of anxiety about using the device. The questionnaire was drawn up by Chen and Chan (2014). This 10-point Likert scale ranges from 1 (strongly disagree) to 10 (strongly agree), with higher marks indicating a better outcome, with the exception of the item on anxiety levels, where higher marks represent a higher level of anxiety in using the WMD.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['community-dwelling older adults', 'Wearable monitoring device'], 'conditions': ['Device Ineffective']}, 'referencesModule': {'references': [{'pmid': '39556810', 'type': 'DERIVED', 'citation': 'Wong AKC, Bayuo J, Su JJ, Wong FKY, Chow KKS, Wong BP, Wong SM, Hui V. Effectiveness of the Support From Community Health Workers and Health Care Professionals on the Sustained Use of Wearable Monitoring Devices Among Community-Dwelling Older Adults: Feasibility Randomized Controlled Trial. J Med Internet Res. 2024 Nov 18;26:e52435. doi: 10.2196/52435.'}, {'pmid': '38134126', 'type': 'DERIVED', 'citation': 'Wong AKC, Tso WC, Su JJ, Hui VCC, Chow KKS, Wong SM, Wong BB, Wong FKY. Effectiveness of support from community health workers on the sustained use of a wearable monitoring device among community-dwelling older adults: A randomized trial protocol. PLoS One. 2023 Dec 22;18(12):e0294517. doi: 10.1371/journal.pone.0294517. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to implement an intervention program to promote the continued use of Wearable Monitoring Devices among older adults through a peer support approach facilitating the incorporation of Wearable Monitoring Devices in daily life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 60 or above\n* own a smartphone\n* able to communicate in Cantonese or Mandarin\n* able to access the Internet at home or elsewhere\n\nExclusion Criteria:\n\n* have a confirmed diagnosis of cognitive impairment\n* bed-bound\n* currently own a wearable monitoring device\n* have already engaged in other wearable device studies'}, 'identificationModule': {'nctId': 'NCT05269303', 'briefTitle': 'Wearable Monitoring Device in Daily Lives of Community-dwelling Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Optimizing the Health-related Functions of a Wearable Monitoring Device in the Daily Life of Community-dwelling Older Adults: A Randomized Pilot Study', 'orgStudyIdInfo': {'id': 'A001523'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Participants will receive a 3-month Live With Wearable Monitoring Device program.', 'interventionNames': ['Device: Live With Wearable Monitoring Device program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Usual care. As with the participants in the intervention group, those in the control group can utilize the features in the Wearable Monitoring Device.'}], 'interventions': [{'name': 'Live With Wearable Monitoring Device program', 'type': 'DEVICE', 'description': 'The participants in the intervention group will receive a home visit by a Community Healthcare Worker in the first month, and biweekly motivational messages via Whats App in the second and third months.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Siu Sai Wan', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Arkers Wong, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Arkers, Wong', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}