Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults
Primary Purpose
Frailty, Caregiver Burnout
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Brief mindfulness based program
Psychoeducation
Sponsored by
About this trial
This is an interventional prevention trial for Frailty
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
Sites / Locations
- The Hong Kong Polytechnic UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Brief mindfulness based program
Psychoeducation
Treatment-as-usual
Arm Description
A four session program, each last for 2.5 hours. Brief mindfulness exercises promote stress reduction, with an introduction of mindfulness to caregivers and home practice is encouraged with guidance.
A four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included.
Outcomes
Primary Outcome Measures
Depression
assessed by a self-reported measure The Center for Epidemiologic Studies Depression Scale, 10 items, sum of scores from 0 to 30, the higher the score, the more severe in the depression symptoms
Secondary Outcome Measures
Caregiver burden
assessed by a self-reported measure Zarit Burden Interview, 22 items, sum of scores from 0 to 88, the higher the score, the more severe in the caregiver burden
Anxiety
assessed by a self-reported measure Hospital Anxiety and Depression Scale -Anxiety subscale, 7 items, sum of scores from 0 to 21, the higher the score, the more severe in the anxiety symptoms
Spiritual well-being
assessed by a self-reported measure Functional Assessment of Chronic Illness, 12 items, sum of scores from 0 to 48, the higher the score, the better the level in well-being Therapy-Spiritual Well-Being Scale
family conflicts
assessed by a self-reported measure Revised Conflict Tactics Scale, 10 items, sum of scores from 0 to 40, the higher the score, the more severe in the level of family conflicts
Heart rate variability
measured by the CorSense Heart Rate Variability monitor, the higher the heart rate variability, the better the ability to self-regulate in response to stressful situations
Coping styles
measured by a self-reported scale brief COPE, 28 items, sum of scores from 28 to 112, the higher the score, the better the level of positive coping
Full Information
NCT ID
NCT04861610
First Posted
April 12, 2021
Last Updated
March 7, 2022
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT04861610
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Caregiver Burnout
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brief mindfulness based program
Arm Type
Experimental
Arm Description
A four session program, each last for 2.5 hours. Brief mindfulness exercises promote stress reduction, with an introduction of mindfulness to caregivers and home practice is encouraged with guidance.
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
A four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included.
Arm Title
Treatment-as-usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief mindfulness based program
Intervention Description
An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
An intervention promotes the coping and problem solving in caregiving for the frail older adults
Primary Outcome Measure Information:
Title
Depression
Description
assessed by a self-reported measure The Center for Epidemiologic Studies Depression Scale, 10 items, sum of scores from 0 to 30, the higher the score, the more severe in the depression symptoms
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Secondary Outcome Measure Information:
Title
Caregiver burden
Description
assessed by a self-reported measure Zarit Burden Interview, 22 items, sum of scores from 0 to 88, the higher the score, the more severe in the caregiver burden
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Title
Anxiety
Description
assessed by a self-reported measure Hospital Anxiety and Depression Scale -Anxiety subscale, 7 items, sum of scores from 0 to 21, the higher the score, the more severe in the anxiety symptoms
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Title
Spiritual well-being
Description
assessed by a self-reported measure Functional Assessment of Chronic Illness, 12 items, sum of scores from 0 to 48, the higher the score, the better the level in well-being Therapy-Spiritual Well-Being Scale
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Title
family conflicts
Description
assessed by a self-reported measure Revised Conflict Tactics Scale, 10 items, sum of scores from 0 to 40, the higher the score, the more severe in the level of family conflicts
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Title
Heart rate variability
Description
measured by the CorSense Heart Rate Variability monitor, the higher the heart rate variability, the better the ability to self-regulate in response to stressful situations
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Title
Coping styles
Description
measured by a self-reported scale brief COPE, 28 items, sum of scores from 28 to 112, the higher the score, the better the level of positive coping
Time Frame
Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Herman, Hay-ming LO, PhD
Phone
+85296279830
Email
herman.lo@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman, Hay-ming LO, PhD
Organizational Affiliation
Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hay-ming Herman Lo, PhD
Phone
852-2766-5769
Email
herman.lo@polyu.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults
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