FrailtyNCT04861610
Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults
A study testing Brief mindfulness based program and Psychoeducation in people with Frailty and Caregiver Burnout, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Frailty, Caregiver Burnout
- What is being tested?
- Brief mindfulness based program and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 May 2021to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, 852
Hay-ming Herman Lo, PhD, 852-2766-5769, herman.lo@polyu.edu.hk
About this study
Official title: Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model
This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.
Read the 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.
- Conditions
- Frailty, Caregiver Burnout
- Being tested
- Brief mindfulness based program, Psychoeducation
- Medical subject headings
- Frailty, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mindfulness based programBehavioural
An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults
PsychoeducationBehavioural
An intervention promotes the coping and problem solving in caregiving for the frail older adults
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Psychoeducation |
| Treatment-as-usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Secondary outcomes (6)
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
Measured: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
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
Measured: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
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
Measured: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
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
Measured: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
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
Measured: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
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
Measured: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start3 May 2021
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Herman, Hay-ming LO, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04861610
- Sponsor's protocol ID
- 15604220
- Status last verified
- Mar 2024
- First submitted
- 12 Apr 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model
- ClinicalTrials.gov ID
- NCT04861610
- Acronym / sponsor ID
- 15604220
- Conditions
- Frailty, Caregiver Burnout
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief mindfulness based program | Experimental | Behavioral: Brief mindfulness based programA 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. |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationA four session program, each last for 2.5 hours. It promotes the coping and problem solving of caregivers. Brief home application included. |
| Treatment-as-usual | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief mindfulness based programAn intervention promotes the acceptance and emotion regulation in caregiving for frail older adults | Behavioural | Brief mindfulness based program |
| PsychoeducationAn intervention promotes the coping and problem solving in caregiving for the frail older adults | Behavioural | Psychoeducation |
Primary outcome
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
6 secondary outcomes
Caregiver burden
Time frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Anxiety
Time frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Spiritual well-being
Time frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
family conflicts
Time frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Heart rate variability
Time frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.
Coping styles
Time frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herman, Hay-ming LO, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mindfulness based program and Psychoeducation in people with Frailty and Caregiver Burnout, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Herman, Hay-ming LO, PhD (+85296279830, herman.lo@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.