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Reappraising Intergeneration Relationships in Dementia Caregiving

Primary Purpose

Alzheimer Dementia

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Perspective Taking Reappraisal
Basic Skill Building
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Dementia focused on measuring Caregiving, Intergeneration, Reappraisal through perspective taking

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria are as follows

  • Primary caregivers aged 20 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 who have been providing unpaid care for more than 12 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 recipient.

Exclusion criteria are as follows:

  • signs of severe intellectual deficits
  • demonstrated suicidal ideation
  • exhibited evidence of psychotic disorders
  • hearing/ visual impairment
  • inability to read or speak Chinese/Cantonese fluently and severe.

Sites / Locations

  • Applied Social Sciences, Hong Kong Polytechnic UniversityRecruiting
  • Institute of Active AgeingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Perspective Taking Reappraisal

Basic Skill Building

Arm Description

This arm focuses on reappraisals with perspective taking with a limited amount of basic skill building

This arm focuses on basic skill building only.

Outcomes

Primary Outcome Measures

Change in Center for Epidemiological Studies-Depression Search Results Center for Epidemiological Studies Depression
20-item measure that asks caregivers to rate how often over the past week they The scale rates experienced symptoms associated with depression.. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater level of having depressive symptoms.
Change in Ryff's Psychological Well-being
The 18-version of the scale taps the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement. The range of scores is from 0 to 108. Higher scores suggest higher levels of well-being. The subscale score of each of the six areas can be calculating by summation of the three items associated with each of the area.

Secondary Outcome Measures

Change in Revised Memory and Problem Checklist
The checklist is a 24-item caregiver-report measure provides a total score plus scores for three subscale memory-related problems, affective distress and disruptive behaviors. Scores are computed for the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "distressed" by each behavior. The caregivers' reaction to each behavior, or the extent of distress experienced, were scored as follows: Reactions are assessed by asking how "upsetting" the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Frequency of behaviors are assessed based on a Likert-scale of 0 to 4 (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often). The range of score is from 0 to 96, higher scores suggesting greater disruption.
Change in MacArther Social Support Scales
The measure the levels of emotional and instrumental social support experienced by the caregivers. The scale consists of 12 items assesses the frequency of receipt of 3 categories of social support: emotional support, instrumental support and negative interaction involving conflict or excessive demands. The participants scored each item on a 5-point Likert Scale ranging from 0 (never) to 4 (frequently). The range of scores is from 0 to 48, with higher score indicating better social support.

Full Information

First Posted
June 28, 2018
Last Updated
December 12, 2018
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03584568
Brief Title
Reappraising Intergeneration Relationships in Dementia Caregiving
Official Title
Reappraising Intergeneration Relationships in Dementia Caregiving Through Perspective Taking
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2018 (Actual)
Primary Completion Date
July 8, 2021 (Anticipated)
Study Completion Date
July 8, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
It is hypothesized that reappraising intergeneration relationships through perspective-taking will enhance the well-being of adult-child caregivers. Incorporating both psychological and social perspectives, the study makes a unique contribution to address research gaps by evaluating an integrated model of intervention for dementia caregivers. The conceptual model involves the following components: 1) relational insights; 2) self-reflection to integrate the challenges and benefits in caregiving; 3) interpersonal empathy To test the incremental value of perspective-taking reappraisals, the study involves a two-arm randomized controlled trial of 12 weeks of intervention with two conditions: 1) Reappraisal through Perspective Taking and 2) Basic Skill Building. Telephone-administered sessions are integrated with group sessions and home visits to maximize sustainability and accessibility of the intervention. One hundred fifty-four participants will be recruited and randomized. Primary outcomes are reduced depressive symptoms and enhanced psychological well-being for the caregivers. Secondary outcomes include enhanced social support for caregivers and reduced behavioral problems in the care-recipients.
Detailed Description
The proposed study aims to address a major research gap in caregiving interventions in the context of intergeneration perspective-taking reappraisals. Adult child caregivers are part of a sandwich generation, involved in actualizing their own goals and coping with social expectations to care for their elderly parents. Dementia caregiving presents a particular challenge in life transition wherein the adult child is parenting his or her parents. With global aging, people living with dementia are rising exponentially. This presents a challenge for sustainable care in Hong Kong and also in countries where public services are developing and the demand for family and intergeneration caregiving is high due to collectivistic concerns. It is hypothesized that reappraising intergeneration relationships through perspective-taking will enhance the well-being of adult-child caregivers. Incorporating both psychological and social perspectives, the study makes a unique contribution to address research gaps by evaluating an integrated model of intervention for dementia caregivers. The conceptual model involves the following components: 1) relational insights; 2) self-reflection to integrate the challenges and benefits in caregiving; 3) interpersonal empathy. Most caregiving psycho-education programs involve skill training including scheduling pleasant events, communicating with the care recipient and other family members. To test the incremental value of perspective-taking reappraisals, the study involves a two-arm randomized controlled trial of 12 weeks of intervention with two conditions: 1) Perspective Taking Reappraisal and 2) Basic Skill Building. Telephone-administered sessions are integrated with home visits to maximize sustainability and accessibility of the intervention. One hundred fifty-four participants will be recruited and randomized. Primary outcomes are reduced depressive symptoms and enhanced psychological well-being for the caregivers. Secondary outcomes include enhanced social support for caregivers and reduced behavioral problems in the care-recipients. Measures are obtained at baseline Weeks 1 (baseline), 6 and 12 with a follow-up at Week 24. Findings have implications for enhancing sustainable care for older adults in the wider society.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Dementia
Keywords
Caregiving, Intergeneration, Reappraisal through perspective taking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perspective Taking Reappraisal
Arm Type
Experimental
Arm Description
This arm focuses on reappraisals with perspective taking with a limited amount of basic skill building
Arm Title
Basic Skill Building
Arm Type
Other
Arm Description
This arm focuses on basic skill building only.
Intervention Type
Behavioral
Intervention Name(s)
Perspective Taking Reappraisal
Intervention Description
Interventions involving 1) appreciating relational insights; 2) enhancing self-awareness; 3) empathetic understanding of care-recipient; 4) integrating self-care and caring for others and 5) negotiation.
Intervention Type
Other
Intervention Name(s)
Basic Skill Building
Intervention Description
These skill-building exercises are commonly used in psycho-education programs for caregivers:monitoring mood and activities, relaxation techniques and scheduling pleasant events, basic communication with the care recipient, communicating the caregivers' own needs with other family member or related persons including helpers and professional staff.
Primary Outcome Measure Information:
Title
Change in Center for Epidemiological Studies-Depression Search Results Center for Epidemiological Studies Depression
Description
20-item measure that asks caregivers to rate how often over the past week they The scale rates experienced symptoms associated with depression.. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater level of having depressive symptoms.
Time Frame
Week 1, 6, 12, 24
Title
Change in Ryff's Psychological Well-being
Description
The 18-version of the scale taps the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement. The range of scores is from 0 to 108. Higher scores suggest higher levels of well-being. The subscale score of each of the six areas can be calculating by summation of the three items associated with each of the area.
Time Frame
Weeks 1,6, 12, 24
Secondary Outcome Measure Information:
Title
Change in Revised Memory and Problem Checklist
Description
The checklist is a 24-item caregiver-report measure provides a total score plus scores for three subscale memory-related problems, affective distress and disruptive behaviors. Scores are computed for the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "distressed" by each behavior. The caregivers' reaction to each behavior, or the extent of distress experienced, were scored as follows: Reactions are assessed by asking how "upsetting" the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Frequency of behaviors are assessed based on a Likert-scale of 0 to 4 (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often). The range of score is from 0 to 96, higher scores suggesting greater disruption.
Time Frame
Weeks 1, 6, 12 ,24
Title
Change in MacArther Social Support Scales
Description
The measure the levels of emotional and instrumental social support experienced by the caregivers. The scale consists of 12 items assesses the frequency of receipt of 3 categories of social support: emotional support, instrumental support and negative interaction involving conflict or excessive demands. The participants scored each item on a 5-point Likert Scale ranging from 0 (never) to 4 (frequently). The range of scores is from 0 to 48, with higher score indicating better social support.
Time Frame
Weeks 1,6, 12, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria are as follows Primary caregivers aged 20 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 who have been providing unpaid care for more than 12 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 recipient. Exclusion criteria are as follows: signs of severe intellectual deficits demonstrated suicidal ideation exhibited evidence of psychotic disorders hearing/ visual impairment inability to read or speak Chinese/Cantonese fluently and severe.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joey Chan, Master
Phone
85227665504
Email
joeycyc.chan@polyu.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Wing-sze Chan, Master
Phone
85234008379
Email
wing-sze.cc.chan@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alma Au, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Social Sciences, Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alma Au, PhD
Phone
85227665504
Email
ssalma@polyu.edu.hk
Facility Name
Institute of Active Ageing
City
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alma Au, PhD
Phone
852-2766-7746
Ext
7746
Email
alma.au@polyu.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25848237
Citation
Au A, Gallagher-Thompson D, Wong MK, Leung J, Chan WC, Chan CC, Lu HJ, Lai MK, Chan K. Behavioral activation for dementia caregivers: scheduling pleasant events and enhancing communications. Clin Interv Aging. 2015 Mar 26;10:611-9. doi: 10.2147/CIA.S72348. eCollection 2015.
Results Reference
background
Links:
URL
https://cerg1.ugc.edu.hk/cergprod/scrrm00542.jsp?proj_id=15606317&old_proj_id=null&proj_title=connecting&isname=&ioname=&institution=&subject=&pages=1&year=2017&theSubmit=15606317
Description
Link to Project Info as funded by the University Grants Committee (General Research Fund)

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Reappraising Intergeneration Relationships in Dementia Caregiving

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