Clinical trial NCT04861610: Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults
Official title: Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Caregiver Burnout
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.

Detailed description: The proposed study is a multi-site, three-arm randomized controlled trial of a mindfulness-based intervention for Chinese family caregivers in Hong Kong. Effects of the intervention will be compared with those of an evidence-based psychoeducation program, and treatment-as-usual. 240 caregivers of frail elderly with moderate to severe levels of frailty, will be recruited and randomly assigned to mindfulness-based intervention, psychoeducation, and treatment-as-usual experimental conditions. Overall program effectiveness will be analyzed on measures of caregiver burden, depression, anxiety, positive caregiving experience, spirituality, family conflict, and the biomarker of heart rate variability. Measures on coping styles, experiential avoidance, and self-efficacy will be explored to see if they mediate the changes to participant improvements in outcomes. 6-month follow-up will be included to investigate the maintenance effects.

Eligibility criteria: Inclusion Criteria:

* Caregivers of frail elderly based on a professional's assessment of Clinical Frailty Scale with a score of 6, indicating a moderate level of frailty or above (Rockwood et al., 2005)
* Caregivers being adult children or children in-law of the elder care receiver
* Caregivers who are experiencing caregiver burden at the time of study, with scores of 8 or above in Zarit Burden Interview-4

Exclusion Criteria:

* impairment, which may present difficulties in comprehending the content of the program
* Spouses, siblings, or friends will be excluded
* Caregivers of elders with moderate to severe dementia will be excluded and the Clinical Dementia Rating Scale will be administered
* Caregivers who had participated in an eight week Mindfulness-Based Stress Reduction or equivalent

Primary outcomes:
measure: Depression
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Secondary outcomes:
measure: Caregiver burden
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
measure: Anxiety
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
measure: Spiritual well-being
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
measure: family conflicts
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
measure: Heart rate variability
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
measure: Coping styles
timeFrame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: Hong Kong Polytechnic University
name: Herman, Hay-ming LO, PhD
role: PRINCIPAL_INVESTIGATOR
References: