Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

NCT ID: NCT04861610

Last Updated: 2024-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2024-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Frailty Caregiver Burnout

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Brief mindfulness based program

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.

Group Type EXPERIMENTAL

Brief mindfulness based program

Intervention Type BEHAVIORAL

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

Psychoeducation

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

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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

Treatment-as-usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Brief mindfulness based program

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

Intervention Type BEHAVIORAL

Psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hong Kong Polytechnic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herman, Hay-ming LO, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Locations

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The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Herman, Hay-ming LO, PhD

Role: CONTACT

+85296279830

Facility Contacts

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Hay-ming Herman Lo, PhD

Role: primary

852-2766-5769

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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15604220

Identifier Type: -

Identifier Source: org_study_id

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