Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

NCT04861610 | Recruiting

• 1 other identifier: 15604220
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Frailty; Caregiver Burnout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Caregiver burden

  Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.

• Anxiety

  Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up

• Spiritual well-being

  Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.

• family conflicts

  Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up

• Heart rate variability

  Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.

Study Arms (3)

Brief mindfulness based program

EXPERIMENTAL

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.

Behavioral: Brief mindfulness based program

Psychoeducation

ACTIVE COMPARATOR

A four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included.

Behavioral: Psychoeducation

Treatment-as-usual

NO INTERVENTION

Interventions

Brief mindfulness based program BEHAVIORAL

An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults

Brief mindfulness based program

Psychoeducation BEHAVIORAL

An intervention promotes the coping and problem solving in caregiving for the frail older adults

Psychoeducation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 852, Hong Kong

RECRUITING

MeSH Terms

Conditions

Frailty; Caregiver Burden

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Herman, Hay-ming LO, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herman, Hay-ming LO, PhD

CONTACT

+85296279830; herman.lo@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 27, 2021
• Study Start: May 3, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)