- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030027
Connecting Through Caregiving: Reappraising Intergeneration Relationships (CTC)
April 12, 2019 updated by: The Hong Kong Polytechnic University
Connecting Through Caregiving: Reappraising Intergeneration Relationships for Dementia Caregivers
The purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Joey Chan, Master
- Phone Number: 852-2766-5504
- Email: joey.cyc.chan@polyu.edu.hk
Study Locations
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-
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Kowloon, Hong Kong
- Recruiting
- Institute of Active Ageing
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Contact:
- Alma Au, PhD
- Phone Number: 7746 852-2766-7746
- Email: alma.au@polyu.edu.hk
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
- Primary caregivers are those who have been providing unpaid care for more than 14 hours a week for at least the past three months.
- 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.
- They can be daughter/son or daughter-/son-in-law of the care recipients.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Connecting Through Caregiving
This arm focuses on perspective-taking reappraisal procedures.
|
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.
|
Other: Basic Skills Building
This arm focuses on skill building.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Life Satisfaction (LS): scale
Time Frame: Change from Baseline LS through study completion, an average of 2 months
|
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
|
Change from Baseline LS through study completion, an average of 2 months
|
Change in Center for Epidemiologic Studies Depressive Scale (CESD)
Time Frame: Change from Baseline CESD through study completion, an average of 2 months
|
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
|
Change from Baseline CESD through study completion, an average of 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Zarit Burden Interview (ZBI)
Time Frame: Change from Baseline ZBI through study completion, an average of 2 months
|
Each of the 22 items required the caregiver to rate on a 5-point scale ranging from 0 (never) to 4 (nearly always).
|
Change from Baseline ZBI through study completion, an average of 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alma Au, {PhD, Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2017
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
January 8, 2017
First Submitted That Met QC Criteria
January 23, 2017
First Posted (Estimate)
January 24, 2017
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 12, 2019
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AFC2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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