Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT05205135
Status:
UNKNOWN
Last Update Posted:
2022-01-24
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility Study of Project Carer Matters for Family Caregivers of Persons With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-01-26', 'releaseDate': '2022-04-26'}, {'resetDate': '2023-11-08', 'releaseDate': '2023-01-30'}], 'estimatedResultsFirstSubmitDate': '2022-04-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-01', 'size': 219336, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-18T19:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-01-18', 'lastUpdatePostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants recruited into programme', 'timeFrame': 'Data will be collected over one year, the duration of the first year of the intervention.', 'description': 'Reach of Carer Matters - Whether Carer Matters Programme affects target population of caregivers. Data collected from programme logs of caregivers recruited not programme and sign-up rates for programmes recommended to participants'}, {'measure': 'Self-reported anxiety scores of CARERS programme participants', 'timeFrame': 'Data will be collected over one year, the duration of the first year of the intervention.', 'description': 'Whether Carer Matters Programme brings about the desired effects in caregiver participants - Reduced anxiety. Data collected through HADS tool administered to caregivers attending CARERS programme.'}, {'measure': 'Self-reported depression scores of CARERS programme participants', 'timeFrame': 'Data will be collected over one year, the duration of the first year of the intervention.', 'description': 'Whether Carer Matters Programme brings about the desired effects in caregiver participants - Reduced depressive symptoms. Data collected through HADS tool administered to caregivers attending CARERS programme.'}, {'measure': 'Self-reported dementia knowledge scores of dementia programme participants', 'timeFrame': 'Data will be collected over one year, the duration of the first year of the intervention.', 'description': 'Whether Carer Matters Programme brings about the desired effects in caregiver participants - Increased dementia knowledge. Data collected through dementia knowledge test designed by team, administered to caregivers attending dementia programme.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Feasibility studies', 'Caregiver', 'Nursing', 'Older person', 'Singapore'], 'conditions': ['Caregivers', 'Caregiver Burden', 'Caregiver Burnout', 'Dementia']}, 'referencesModule': {'references': [{'pmid': '39695613', 'type': 'DERIVED', 'citation': 'Wu LT, Glass GF Jr, Chew EYH, Ng EJY, Chan EY. Developing a theory of change to guide the design and implementation of a caregiver-centric support service. BMC Health Serv Res. 2024 Dec 18;24(1):1620. doi: 10.1186/s12913-024-11931-y.'}, {'pmid': '35854296', 'type': 'DERIVED', 'citation': 'Chan EY, Wu LT, Ng EJY, Glass GF Jr, Tan RHT. Applying the RE-AIM framework to evaluate a holistic caregiver-centric hospital-to-home programme: a feasibility study on Carer Matters. BMC Health Serv Res. 2022 Jul 19;22(1):933. doi: 10.1186/s12913-022-08317-3.'}]}, 'descriptionModule': {'briefSummary': "The study uses the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework to assess the Carer Matters programme for dementia caregivers in Singapore. A parallel mixed-methods study design is applied to assess the programme's feasibility and effectiveness.", 'detailedDescription': "A mixed-methods study to (1) Evaluate the feasibility of Carer Matters for caregivers of PwD and to (2) Explore perspectives of key stakeholders who are directly or indirectly involved with Carer Matters, to better understand the potential sustainability of this framework.\n\nThe objectives of are as follows:\n\n1. To explore the perceptions, attitudes and beliefs of family caregivers, healthcare workers and community partners towards Carer Matters.\n2. To explore the barriers and facilitators of acceptance and implementation of Carer Matters.\n3. To gain insights into the perceived demand of Carer Matters.\n4. To gain insights into the family caregivers' preliminary responses to and outcomes from Carer Matters.\n\nThe study will involve six inpatient wards of a 1,700-bedded tertiary care hospital which are piloting Carer Matters. These wards comprise of four acute wards and two sub-acute wards. They are selected as they admit a comparatively greater number of patients with dementia than other wards in the hospital. The study will be conducted over 12 months.\n\nQuantitative data is based off programme data collected from all caregivers who undergo Carer Matters. Hence, it will consist of all dementia caregivers whose care recipient is admitted into the pilot wards and agree to participate in Carer Matters.\n\nQualitative data is based off interviews of key stakeholders of the different components of the Carer Matters programme. The key stakeholders comprises: (1) Family caregivers of PwD (n = 25 to 30), (2) Ward nurses (n= 8 to 10), (3) Care support nurses (n = 2 to 3), (4) Intervention programmes facilitators and standardized patients (n = 3), (5) Community partners and hospital leaders (n = 4), and (6) Other clinicians - medical social workers, physiotherapists, occupational therapists and doctors (n = 4 to 5).\n\nBoth qualitative and quantitative data will be triangulated using the RE-AIM framework address the research objectives of the study. These insights will then be used to generate an updated Theory of Change model explaining how SHARE improves caregiver capacity for sustained caregiving. This final model will reflect the processes and mechanisms of Carer Matters that contribute towards the short, medium and long-term outcomes intended, and can serve as a guide for future researchers and practitioners."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible caregivers whose person with dementia are admitted into the pilot wards and receive the SHARE programme will be invited to participate\n\nAll eligible ward nurses and clinicians who work in pilot wards where SHARE is ongoing will be invited to participate.\n\nAll eligible care support nurses and programme facilitators will be invited to participate, as they are all involved in SHARE.\n\nEligible hospital leaders and community leaders who have worked with the SHARE programme will be invited to participate.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For family caregivers: (1) Above 21 years of age, (2) The main family caregiver of the PwD receiving home-based care, (3) Able to converse in English language, and (4) Willing to have their interviews audio-recorded.\n* For ward nurses: (1) Above 21 years of age, (2) Working as a nurse at one of the inpatient wards piloting SHARE, (3) Referred family caregivers to complete the brief screening tool, and (4) Willing to have their interviews audio-recorded.\n* For care support nurses: (1) Above 21 years of age, (2) Involved in either providing direct or indirect patient care to a PwD and their caregiver through SHARE, and (3) Willing to have their interviews audio-recorded.\n* For community leaders and hospital leaders: (1) Above 21 years of age, (2) Key decision makers or in leadership positions within the hospital or Working in institutions where there are ongoing or potentially future partnerships with TTSH to provide care services , and (3) Willing to have their interviews audio-recorded.\n* For other clinicians: (1) Above 21 years of age, (2) Working as a clinicians at one of the inpatient wards piloting SHARE, (3) Referred family caregivers to complete the brief screening tool, and (4) Willing to have their interviews audio-recorded.\n\nExclusion Criteria: any potential participant who refuses to have their interviews recorded\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05205135', 'briefTitle': 'Feasibility Study of Project Carer Matters for Family Caregivers of Persons With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Tan Tock Seng Hospital'}, 'officialTitle': 'Feasibility Study of Project Carer Matters for Family Caregivers of People With Dementia Receiving Home-based Caregiving', 'orgStudyIdInfo': {'id': 'GERI1626'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Caregivers', 'description': 'Caregivers of persons with dementia supported by the Carer Matters programme', 'interventionNames': ['Behavioral: SHARE Programme']}, {'label': 'Nurses', 'description': 'Ward nurses who collaborate with the Carer Matters team', 'interventionNames': ['Behavioral: SHARE Programme']}, {'label': 'Programme facilitators', 'description': 'Facilitators of programmes organised through Carer Matters', 'interventionNames': ['Behavioral: SHARE Programme']}, {'label': 'Care Support Nurses', 'description': 'Nurses trained to deliver support and assistance as part of Carer Matters Programme', 'interventionNames': ['Behavioral: SHARE Programme']}, {'label': 'Community partners and hospital leaders', 'description': 'Key policy makers and community leaders who partner with the Carer Matters programme to ensure its success', 'interventionNames': ['Behavioral: SHARE Programme']}, {'label': 'Other clinicians (e.g. Social workers, Physiotherapists, doctors)', 'description': 'Other clinicians who refer caregivers to the Carer Matters programme', 'interventionNames': ['Behavioral: SHARE Programme']}], 'interventions': [{'name': 'SHARE Programme', 'type': 'BEHAVIORAL', 'description': "SHARE is Singapore's first 'Hospital-to-Home' programme to screen, identify and provide targeted interventions for caregivers at-risk of caregiver burden. Our interventions include psychosocial and emotional preparation of caregivers' mental resilience, and long-term engagement initiatives to connect caregivers into an integrated network of peers and community support services, delivered by programme facilitators and care support nurses.\n\nKey stakeholders essential for the success of share include ward nurses and clinicians who refer caregivers to SHARE and community partners and hospital leaders.\n\nThis study seeks to recruit all of these individuals to better understand their experience of SHARE and the facilitators and barriers to its successful rollout to better evaluate the feasibility of SHARE in the hospital to home setting.", 'armGroupLabels': ['Care Support Nurses', 'Caregivers', 'Community partners and hospital leaders', 'Nurses', 'Other clinicians (e.g. Social workers, Physiotherapists, doctors)', 'Programme facilitators']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Ee Yuee Chan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tan Tock Seng Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plans for IPD sharing, due to sensitivity of information shared over interviews.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Geriatric Education and Research Institute', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-26', 'type': 'RELEASE'}, {'date': '2023-01-26', 'type': 'RESET'}, {'date': '2023-01-30', 'type': 'RELEASE'}, {'date': '2023-11-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Tan Tock Seng Hospital'}}}}