Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-06 @ 2:40 AM
Study NCT ID:
NCT03030027
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2017-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Connecting Through Caregiving: Reappraising Intergeneration Relationships
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2017-01-08', 'studyFirstSubmitQcDate': '2017-01-23', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Life Satisfaction (LS): scale', 'timeFrame': 'Change from Baseline LS through study completion, an average of 2 months', 'description': 'Each response was rated from to 7 on each of the 5 items of the scale with higher score indicating higher level of life satisfaction'}, {'measure': 'Change in Center for Epidemiologic Studies Depressive Scale (CESD)', 'timeFrame': 'Change from Baseline CESD through study completion, an average of 2 months', 'description': 'Each response was rated from 0 to 3 on a scale of the frequency of the occurrence of the symptom in the past week. Higher scores would suggest a higher'}], 'secondaryOutcomes': [{'measure': 'Change in Zarit Burden Interview (ZBI)', 'timeFrame': 'Change from Baseline ZBI through study completion, an average of 2 months', 'description': 'Each of the 22 items required the caregiver to rate on a 5-point scale ranging from 0 (never) to 4 (nearly always).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intergeneration', 'Reappraisal', 'Caregiving'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.', 'detailedDescription': 'Dementia caregiving presents a particular challenge wherein the adult child is parenting his or her parents. Facilitating relational insights, the key components of the Connecting Through Caregiving (CTC) intervention involves the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy of the care-recipient, 3) help-seeking, 4) balancing self-care and caring for others and 5) negotiating action plans. The CTC intervention is be evaluated against a basic skill training intervention consisting of scheduling pleasant events, communicating with the care recipient and other family members. Dementia caregivers providing at least 14 hours of care per week to a parent living with dementia are recruited and randomized into one the two conditions. The intervention lasts for six weeks for both conditions. Intervention in the first week consists of a home visit and a telephone follow-up. From the second to fifth week, there are weekly four telephone phone sessions. In the sixth week, there were two more telephone calls to consolidate the intervention and to review implementation plans.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The study participants will be primary caregivers aged 18 or older and who have been caring for persons (aged 60 or above) with a physician diagnosis of Alzheimer's disease in the mild to moderate range as determined by the Clinical Dementia Rating Scale.\n* Primary caregivers are those who have been providing unpaid care for more than 14 hours a week for at least the past three months.\n* The care should involve day-to-day decision-making as well as any of the following: feeding, dressing, bathing, toileting, housework, preparing meals, medication and handling finances.\n* They can be daughter/son or daughter-/son-in-law of the care recipients.\n\nExclusion Criteria:\n\n* Exclusion criteria are as follows: signs of severe intellectual deficits, demonstrated suicidal ideation, exhibited evidence of psychotic disorders, hearing/ visual impairment or inability to read or speak Chinese/Cantonese fluently and severe."}, 'identificationModule': {'nctId': 'NCT03030027', 'acronym': 'CTC', 'briefTitle': 'Connecting Through Caregiving: Reappraising Intergeneration Relationships', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Connecting Through Caregiving: Reappraising Intergeneration Relationships for Dementia Caregivers', 'orgStudyIdInfo': {'id': 'AFC2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Connecting Through Caregiving', 'description': 'This arm focuses on perspective-taking reappraisal procedures.', 'interventionNames': ['Behavioral: Connecting Through Caregiving']}, {'type': 'OTHER', 'label': 'Basic Skills Building', 'description': 'This arm focuses on skill building.', 'interventionNames': ['Other: Basic Skills Building']}], 'interventions': [{'name': 'Connecting Through Caregiving', 'type': 'BEHAVIORAL', 'description': 'The Connecting Through Caregiving intervention focuses on reappraisal exercises on intergeneration relationships in caregiving, involving the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy for the care-recipient, 3) help-seeking in caregiving, 4) balancing self-care and caring and 5) negotiating action plans.', 'armGroupLabels': ['Connecting Through Caregiving']}, {'name': 'Basic Skills Building', 'type': 'OTHER', 'description': 'Skill building involves: 1) monitoring activities, 2) pleasant event scheduling, 3) communicating with the care recipient, 4) communicating with family members and 5) review implementation', 'armGroupLabels': ['Basic Skills Building']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Alma Au, PhD', 'role': 'CONTACT', 'email': 'alma.au@polyu.edu.hk', 'phone': '852-2766-7746', 'phoneExt': '7746'}], 'facility': 'Institute of Active Ageing', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Joey Chan, Master', 'role': 'CONTACT', 'email': 'joey.cyc.chan@polyu.edu.hk', 'phone': '852-2766-5504'}], 'overallOfficials': [{'name': 'Alma Au, {PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hong Kong Polytechnic University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}