Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03584568
Other study ID # GRFPTR2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 11, 2018
Est. completion date July 8, 2021

Study information

Verified date December 2018
Source The Hong Kong Polytechnic University
Contact Joey Chan, Master
Phone 85227665504
Email joeycyc.chan@polyu.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 154
Est. completion date July 8, 2021
Est. primary completion date July 8, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Perspective Taking Reappraisal
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.
Other:
Basic Skill Building
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.

Locations

Country Name City State
Hong Kong Applied Social Sciences, Hong Kong Polytechnic University Hong Kong
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, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Week 1, 6, 12, 24
Primary 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. Weeks 1,6, 12, 24
Secondary 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. Weeks 1, 6, 12 ,24
Secondary 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. Weeks 1,6, 12, 24
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03255720 - Application of Diffusion Tensor Imaging in Alzheimer's Disease :Quantification of White Matter Micro-structural Changes N/A
Recruiting NCT03507192 - Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia. N/A
Withdrawn NCT05497817 - A Study to Evaluate Caregiver Connections Via Technology for Patients With Alzheimer's and Other Types of Dementia N/A
Completed NCT02317523 - Alzheimer's Caregiver Coping: Mental and Physical Health N/A
Completed NCT03538522 - A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831 Phase 2
Terminated NCT03132272 - Immunoadsorption for Treatment of Alzheimer's Disease N/A
Recruiting NCT03275363 - The University of Hong Kong Neurocognitive Disorder Cohort N/A
Enrolling by invitation NCT03724136 - Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study N/A
Completed NCT02267486 - Exploratory Study for the Validity of QuQu Scale N/A
Active, not recruiting NCT03748303 - Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study Phase 1
Completed NCT03611439 - Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients N/A
Completed NCT04058886 - Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers N/A
Not yet recruiting NCT05113732 - Association of Cognition With Functional Mobility in People With Alzheimer's Disease
Completed NCT03811847 - A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants. Phase 4
Terminated NCT03044249 - A Study of MP-101 in Dementia-Related Psychosis and/or Agitation and Aggression Phase 2
Active, not recruiting NCT03661034 - Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study) N/A
Completed NCT03718494 - Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
Completed NCT03602391 - The Senior Companion Program Plus N/A
Completed NCT03548584 - A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type Phase 3
Recruiting NCT02951559 - SOLFAMU Study of Nasal Brushing Collected OLFActory MUcosa Samples in the Diagnosis of Human Encephalopathies Phase 4