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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03030027
Other study ID # AFC2016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2017
Est. completion date December 31, 2020

Study information

Verified date January 2017
Source The Hong Kong Polytechnic University
Contact Joey Chan, Master
Phone 852-2766-5504
Email joey.cyc.chan@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Connecting Through Caregiving
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
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

Locations

Country Name City State
Hong Kong Institute of Active Ageing Kowloon

Sponsors (1)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Life Satisfaction (LS): scale 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
Primary Change in Center for Epidemiologic Studies Depressive Scale (CESD) 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 Change in Zarit Burden Interview (ZBI) 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
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