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Caregiver BurdenNCT05242614

The Effects of a Hybrid Face-To-Face and Online Mode of Delivering a Mindfulness-Based Dementia Caregiving Programme for Family Caregivers of Persons With Dementia: A Randomized Controlled Trial

A study testing The Hybrid Mindfulness-based Dementia caregiving program (MBDCP) and Psychoeducation educational program in people with Caregiver Burden, run by The Hong Kong Polytechnic University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Mindfulness-based intervention (MBI) has been shown promising effects in enhancing the well-being of caregivers of patients with dementia (PWD). However, the time schedule and the mode of delivering the conventional MBI was demanding to family caregivers of PWD, and therefore impeding the feasibility of use among… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Caregiver Burden
What is being tested?
The Hybrid Mindfulness-based Dementia caregiving program (MBDCP) and Psychoeducation educational program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
No sites listed yet
Study dates
1 Mar 2022to 30 Jun 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Caregivers who are aged 18 or above
  • Caregivers who are taking care for a family member medically diagnosed with dementia who has been residing in the community;
  • Caregivers who are providing care to the dementia care recipients for at least 6 months prior to the subject recruitment.

Who cannot join

  • Caregivers who have participated in any structured psychosocial intervention or mindfulness-based intervention/training in the 6 months prior to recruitment,
  • Caregivers who have acute psychiatric and medical comorbidities that are potentially life-threatening (e.g., suicidal ideation) or leave them with a limited ability to participate or adhere to the intervention (e.g., acute psychosis),
  • caregivers who do not have Internet access.

Trial locations and contacts

No sites are listed yet.

Pui Kin Patrick Kor contact

2766 5622

patrick.kor@polyu.edu.hk

About this study

Mindfulness-based intervention (MBI) has been shown promising effects in enhancing the well-being of caregivers of patients with dementia (PWD). However, the time schedule and the mode of delivering the conventional MBI was demanding to family caregivers of PWD, and therefore impeding the feasibility of use among caregivers. Our research team had developed a hybrid MBI program which includes face to face and online mode of mindfulness sessions w. The study aims to evaluate the effectiveness of this 6-week hybrid MBI program on caregivers of PWD over a 6-month follow up. This study is a two-arm parallel randomized controlled trial. Participants are family caregivers of PWD and we aimed to recruit 290 subjects. Eligible participants will be recruited from three local nongovernmental organizations (NGOs) in Hong Kong. They will be randomly allocated into MBI group and a control group (with 145 participants in each group) . The participants in the MBI group will receive 6 weekly 90-minute group-based sessions delivered through a face-to-face and online approach. The participants in control group will receive brief education on dementia care with the same group size, duration, and frequency as the sessions in the intervention group. Assessment (using questionnaire) about caregiving stress and other outcomes (positive aspect of caregiving, depression, dyadic relationship, anxiety, neuropsychiatric symptoms of patients) will be assessed at baseline, immediately after the intervention and at the 6-month follow up. Focus group interview will also be conducted to explore family caregivers' experience in participating in the program. We aimed to recruit 20 caregivers for the interviews via purposive sampling. It is hypothesized that compared to the control group, the MBI group will have a reduction on caregiving stress and improve other outcomes after the intervention.

Being tested
The Hybrid Mindfulness-based Dementia caregiving program (MBDCP), Psychoeducation educational program
Medical subject headings
Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Hybrid Mindfulness-based Dementia caregiving program (MBDCP)Behavioural

    The hybrid MBDCP includes 6 weekly 90-minute group-based sessions delivered through a face-to-face (1st, 2nd, and 6th sessions) and online approach (3rd, 4th, and 5th sessions). The online session is designed for self-directed learning. The MBDCP includes different mindfulness practices (e.g., mindful eating, body scanning, and mindful walking), psychoeducation on caregiving, and group sharing, aimed at helping caregivers to develop mindfulness skills through the formal and informal practice of mindfulness, and to integrate these skills into their everyday life. The duration of each session is 90 minutes. Th MBDCP will be delivered by a qualified mindfulness therapist. In the MBDCP's online sessions, the caregivers will watch a teaching video (e.g., a video demonstrating mindfulness practices) through a website.

  • Psychoeducation educational programBehavioural

    This program serves as a control for the social effects of the MBDCP. The brief education program consists of 6 weekly 90-minutes group sessions in which the sessions (1st, 2nd, and 6th) and (3rd 4th 5th) will be delivered through the face-to-face and online approach respectively, with the similar group size of the MBDCP. The education contents include caregiving skills, education on mood, and group sharing. The program will be led by a nurse.

Study groups in NCT05242614
Study groupRoleWhat they receive
A hybrid Mindfulness-based Dementia Caregiving Program (MBDCP)ExperimentalParticipants from the experimental group will receive a hybrid Mindfulness-based Dementia Caregiving Program (MBDCP). It is a 6-week program. In the 1st, 2nd and 6th session, it is delivered through face to face, while in the 3rd, 4th and 5th sessions, it will be delivered via online approach.
Receives: Behavioral: The Hybrid Mindfulness-based Dementia caregiving program (MBDCP)
Control groupActive comparatorThe family caregivers in the control group will receive 6 week education programme on dementia. It is a control for the social effects of the MBDCP. In the 1st, 2nd and 6th session, it is delivered through face to face, while in the 3rd, 4th and 5th sessions, it will be delivered via online approach.
Receives: Behavioral: Psychoeducation educational program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in perceived Stress scale of caregivers

    The change in stress will be measured by the Chinese version of perceived stress scale (Cohen et al., 1983) . The PSS contains 10 items. It is a 5 point Likert scale (1= never, 5=Very often). The total score is ranged from 10 to 50. A higher score indicating higher level of perceived stress

    Measured: baseline, immediately after the intervention, 6 month- after the intervention

Secondary outcomes (6)

  1. Change in depressive symptoms of caregivers

    The change in depressive symptoms will be measured by the Centre for Epidemiologic Studies Depression scale (CESD) (Robert \& Vernon, 1983) . It is a self-reported measurement containing 20 items. Rating were based on a 4 point likert scale ranging from 0 (Rarely or none of the time) to 3 (most or all of the time). The total score is ranged from 0-60. A higher score indicates a higher level of depression

    Measured: baseline, immediately after the intervention, 6 month- after the intervention

  2. Change in positive caregiving experience of caregivers

    This will be measured by thePositive aspect of caregiving scale (PAC) (Kate et al., 2012) . The PAC contains 11 items with 5 point likert scale for all item responses. The total score ranged from 11 to 55. , with higher score indicating a more positive perception of caregiving.

    Measured: baseline, immediately after the intervention, 6 month- after the intervention

  3. Change in caregiving burden of caregivers

    This will be measured by the Zarit Burden Interview (ZBI) (Zarit et al,1980) . The scale comprises of 22 items. Items are presented in the format of 5 point Likert scale (0= None, 4=Extremely distressing). The total score is ranged from 0-88, with a higher score representing a higher level of caregiving burden.

    Measured: baseline, immediately after the intervention, 6 month- after the intervention

  4. Change in dyadic relationship

    This will be measured using the dyadic relationship scale(Sebern \& Whitlatch, 2007). This scale is completed by the family caregivers and it assesses a variety of relationship stressor. Items are presented in a format of 4 point Likert scale (1= strongly disagree, 4 =strongly agree). The scale contains two subscale scores: dyadic strain (range of score: 5-20) and positive dyadic relationship (range of score: 6 to 24) . Higher score on each of these scales indicate higher level of strain and positive interactions respectively.

    Measured: baseline, immediately after the intervention, 6 month- after the intervention

  5. Change in heart rate variability of caregivers

    This will be measured by using validated Polar heart rate monitors. Heart rate variability will be interpreted following the guidelines for the Standard measurement and interpretation of HRV (European Society of Cardiology and the North American Society of Pacing and Electrophysiology) using the frequency domain method ( Vanderlei et al 2008; Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology, 1996).

    Measured: baseline, immediately after the intervention, 6 month- after the intervention

  6. Change in neuropsychiatric symptoms of the care recipients

    This will be measured by the Neuropsychiatric inventory Questionnaire (NPI-Q) (Cummings et al., 1994) through caregivers. NPI-Q is an informant based instrument that measures the presence and severity of 12 symptoms in patients with dementia and caregivers distress. The caregivers will be asked to identify whether the symptoms of the care recipients had been present in the past week, and rate the severity of the symptoms (from a likert scale ranged from 1 to 3) and the corresponding distress to them( from likert scale ranged from 1 to 5). The NPI-Q provides two scores, namely, total severity of symptoms (range of score: 12 to 36) and total distress scores (range of score: 12 to 60). The higher scores of these two subscales represent a higher level of symptoms severity of care recipients and distress of caregivers.

    Measured: baseline, immediately after the intervention, 6 month- after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2022
  2. Study start1 Mar 2022 (estimated)
  3. Primary completion1 Oct 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a two-arm parallel randomized controlled trial, with an intervention group (mindfulness group) and a control group. The participants in the MBI group will receive 6 weekly 90-minute group-based sessions delivered through a face-to-face and online approach. The participants in control group will receive brief education on dementia care with the same group size, duration, and frequency as the sessions in the intervention group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242614
Sponsor's protocol ID
HSEARS20210709005
Status last verified
Feb 2022
First submitted
8 Feb 2022
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PubMed 6668417

  • Roberts RE, Vernon SW. The Center for Epidemiologic Studies Depression Scale: its use in a community sample. Am J Psychiatry. 1983 Jan;140(1):41-6. doi: 10.1176/ajp.140.1.41.

    PubMed 6847983

  • Kate N, Grover S, Kulhara P, Nehra R. Scale for positive aspects of caregiving experience: development, reliability, and factor structure. East Asian Arch Psychiatry. 2012 Jun;22(2):62-9.

    PubMed 22714876

  • Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.

    PubMed 7203086

  • Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.

    PubMed 18192628

  • Vanderlei LC, Silva RA, Pastre CM, Azevedo FM, Godoy MF. Comparison of the Polar S810i monitor and the ECG for the analysis of heart rate variability in the time and frequency domains. Braz J Med Biol Res. 2008 Oct;41(10):854-9. doi: 10.1590/s0100-879x2008005000039. Epub 2008 Sep 30.

    PubMed 18853042

  • Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

    PubMed 8598068

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

    PubMed 16443717

  • Cummings JL, Mega M, Gray K, Rosenberg-Thompson S, Carusi DA, Gornbein J. The Neuropsychiatric Inventory: comprehensive assessment of psychopathology in dementia. Neurology. 1994 Dec;44(12):2308-14. doi: 10.1212/wnl.44.12.2308.

    PubMed 7991117

  • Kor PPK, Tsang APL, Lai DLL, Liu JYW. The effectiveness of a hybrid mindfulness-based intervention in reducing stress among informal caregivers of people with dementia: a randomized controlled trial. Gerontologist. 2025 Nov 10;65(12):gnaf281. doi: 10.1093/geront/gnaf281.

    PubMed 41275399

  • Kor PPK, Li ML, Kwok DKS, Leung AYM, Lai DLL, Liu JYW. Evaluating the effectiveness of a 6-week hybrid mindfulness-based intervention in reducing the stress among caregivers of patients with dementia during COVID-19 pandemic: protocol of a randomized controlled trial. BMC Psychol. 2022 Jul 19;10(1):178. doi: 10.1186/s40359-022-00876-8.

    PubMed 35854347

Questions about this trial

What is this clinical trial studying?

A study testing The Hybrid Mindfulness-based Dementia caregiving program (MBDCP) and Psychoeducation educational program in people with Caregiver Burden, run by The Hong Kong Polytechnic University.

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 3 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 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Pui Kin Patrick Kor (2766 5622, patrick.kor@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in perceived Stress scale of caregivers (time frame: baseline, immediately after the intervention, 6 month- after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05242614, which also lists 11 linked publications.

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 16 Feb 2022.

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