Alzheimer DementiaNCT03584568
Reappraising Intergeneration Relationships in Dementia Caregiving
A study testing Perspective Taking Reappraisal and Basic Skill Building in people with Alzheimer Dementia, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia
- What is being tested?
- Perspective Taking Reappraisal and Basic Skill Building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesHong Kong
- Study dates
- 11 Nov 2018to 8 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Applied Social Sciences, Hong Kong Polytechnic University
Hong Kong
Alma Au, PhD, 85227665504, ssalma@polyu.edu.hk
- Recruiting
Institute of Active Ageing
Kowloon
Alma Au, PhD, 852-2766-7746 ext. 7746, alma.au@polyu.edu.hk
About this study
Official title: Reappraising Intergeneration Relationships in Dementia Caregiving Through Perspective Taking
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.
Read the 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.
- Conditions
- Alzheimer Dementia
- Being tested
- Perspective Taking Reappraisal, Basic Skill Building
- Keywords
- Caregiving, Intergeneration, Reappraisal through perspective taking
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perspective Taking ReappraisalBehavioural
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.
Basic Skill BuildingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Perspective Taking Reappraisal | Experimental | This arm focuses on reappraisals with perspective taking with a limited amount of basic skill building Receives: Behavioral: Perspective Taking Reappraisal; Other: Basic Skill Building |
| Basic Skill Building | Other | This arm focuses on basic skill building only. Receives: Other: Basic Skill Building |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, 6, 12, 24
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.
Measured: Weeks 1,6, 12, 24
Secondary outcomes (2)
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.
Measured: Weeks 1, 6, 12 ,24
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.
Measured: Weeks 1,6, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start11 Nov 2018
- Primary completion8 Jul 2021 (estimated)
- Study completion8 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DementiaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Au May-lan Alma, The Hong Kong Polytechnic University
- Investigators
- Alma Au, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584568
- Sponsor's protocol ID
- GRFPTR2018
- Status last verified
- Dec 2018
- First submitted
- 28 Jun 2018
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25848237
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reappraising Intergeneration Relationships in Dementia Caregiving Through Perspective Taking
- ClinicalTrials.gov ID
- NCT03584568
- Acronym / sponsor ID
- GRFPTR2018
- Conditions
- Alzheimer Dementia
- Keywords
- Caregiving, Intergeneration, Reappraisal through perspective taking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 8 Jul 2021 (estimated)
- Study completion
- 8 Jul 2021 (estimated)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perspective Taking Reappraisal | Experimental | Behavioral: Perspective Taking Reappraisal, Other: Basic Skill BuildingThis arm focuses on reappraisals with perspective taking with a limited amount of basic skill building |
| Basic Skill Building | Other | Other: Basic Skill BuildingThis arm focuses on basic skill building only. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perspective Taking ReappraisalInterventions 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. | Behavioural | Perspective Taking Reappraisal |
| Basic Skill BuildingThese 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. | Other | Basic Skill Building, Perspective Taking Reappraisal |
Primary outcome
Change in Center for Epidemiological Studies-Depression Search Results Center for Epidemiological Studies Depression
Time frame: Week 1, 6, 12, 24
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
Time frame: Weeks 1,6, 12, 24
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.
2 secondary outcomes
Change in Revised Memory and Problem Checklist
Time frame: Weeks 1, 6, 12 ,24
Change in MacArther Social Support Scales
Time frame: Weeks 1,6, 12, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Background: PubMed 25848237Au 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.
- Link to Project Info as funded by the University Grants Committee (General Research Fund)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alma Au, PhD principal investigator
The Hong Kong Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perspective Taking Reappraisal and Basic Skill Building in people with Alzheimer Dementia, run by The Hong Kong Polytechnic University at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joey Chan, Master (85227665504, joeycyc.chan@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Center for Epidemiological Studies-Depression Search Results Center for Epidemiological Studies Depression (time frame: Week 1, 6, 12, 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.