Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

Frailty Clinical Trial

Official title:

Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04861610
• Other study ID #: 15604220
• Status: Recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: The Hong Kong Polytechnic University
• Contact: Herman, Hay-ming LO, PhD
• Phone: +85296279830
• Email: herman.lo[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Frailty

Intervention

Behavioral:
• Brief mindfulness based program
An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults
• Psychoeducation
An intervention promotes the coping and problem solving in caregiving for the frail older adults

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Secondary	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Secondary	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Secondary	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Secondary	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Secondary	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Secondary	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	Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up