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Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults

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ClinicalTrials.gov Identifier: NCT04861610
Recruitment Status : Recruiting
First Posted : April 27, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

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

Condition or disease Intervention/treatment Phase
Frailty Caregiver Burnout Behavioral: Brief mindfulness based program Behavioral: Psychoeducation Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model
Actual Study Start Date : May 3, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Behavioral: Brief mindfulness based program
An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults
Active Comparator: Psychoeducation
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
An intervention promotes the coping and problem solving in caregiving for the frail older adults
No Intervention: Treatment-as-usual


Outcome Measures
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Primary Outcome Measures :
  1. Depression [ Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up ]
    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 :
  1. Caregiver burden [ Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up. ]
    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

  2. Anxiety [ Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up ]
    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

  3. Spiritual well-being [ Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up. ]
    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

  4. family conflicts [ Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up ]
    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

  5. Heart rate variability [ Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up. ]
    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

  6. Coping styles [ Time Frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up ]
    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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04861610


Contacts
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Contact: Herman, Hay-ming LO, PhD +85296279830 herman.lo@polyu.edu.hk

Locations
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Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Hong Kong, 852
Contact: Hay-ming Herman Lo, PhD    852-2766-5769    herman.lo@polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Herman, Hay-ming LO, PhD Hong Kong Polytechnic University
  Study Documents (Full-Text)

Documents provided by The Hong Kong Polytechnic University:
Study Protocol and Statistical Analysis Plan  [PDF] April 22, 2021
Informed Consent Form  [PDF] April 22, 2021

More Information
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04861610    
Other Study ID Numbers: 15604220
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Caregiver Burden
Pathologic Processes
Stress, Psychological
Behavioral Symptoms