DementiaCTCNCT03030027
Connecting Through Caregiving: Reappraising Intergeneration Relationships
A study testing Connecting Through Caregiving and Basic Skills Building in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Connecting Through Caregiving and Basic Skills Building
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 9 Jan 2017to 31 Dec 2020
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Institute of Active Ageing
Kowloon
Alma Au, PhD, 852-2766-7746 ext. 7746, alma.au@polyu.edu.hk
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Connecting Through Caregiving, Basic Skills Building
- Keywords
- Intergeneration, Reappraisal, Caregiving
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connecting Through CaregivingBehavioural
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.
Basic Skills BuildingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Connecting Through Caregiving | Experimental | This arm focuses on perspective-taking reappraisal procedures. Receives: Behavioral: Connecting Through Caregiving |
| Basic Skills Building | Other | This arm focuses on skill building. Receives: Other: Basic Skills Building |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline LS through study completion, an average of 2 months
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
Measured: Change from Baseline CESD through study completion, an average of 2 months
Secondary outcomes (1)
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).
Measured: Change from Baseline ZBI through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start9 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alma Au, {PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030027
- Sponsor's protocol ID
- AFC2016
- Acronym
- CTC
- Status last verified
- Jan 2017
- First submitted
- 8 Jan 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Through Caregiving: Reappraising Intergeneration Relationships for Dementia Caregivers
- ClinicalTrials.gov ID
- NCT03030027
- Acronym / sponsor ID
- CTC / AFC2016
- Conditions
- Dementia
- Keywords
- Intergeneration, Reappraisal, Caregiving
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 24 Jan 2017 (estimated)
- 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.
The purpose of the present study is to examine the effects of perspective-taking reappraisals on the well-being of adult-child dementia caregivers.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connecting Through Caregiving | Experimental | Behavioral: Connecting Through CaregivingThis arm focuses on perspective-taking reappraisal procedures. |
| Basic Skills Building | Other | Other: Basic Skills BuildingThis arm focuses on skill building. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Connecting Through CaregivingThe 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. | Behavioural | Connecting Through Caregiving |
| Basic Skills BuildingSkill building involves: 1) monitoring activities, 2) pleasant event scheduling, 3) communicating with the care recipient, 4) communicating with family members and 5) review implementation | Other | Basic Skills Building |
Primary outcome
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 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
1 secondary outcome
Change in Zarit Burden Interview (ZBI)
Time frame: Change from Baseline ZBI through study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connecting Through Caregiving and Basic Skills Building in people with Dementia, run by The Hong Kong Polytechnic University at 1 site 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 1 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (852-2766-5504, joey.cyc.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 Life Satisfaction (LS): scale (time frame: Change from Baseline LS through study completion, an average of 2 months). 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?
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 16 Apr 2019.