NCT05242614

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

Status unknown NA Last updated 16 February 2022

What this trial tests

NA trial testing The Hybrid Mindfulness-based Dementia caregiving program (MBDCP) in Caregiver Burden in 290 participants. Status unknown.

Timeline

1 March 2022

Primary endpoint
1 October 2023

30 June 2024

Quick facts

Lead sponsor	The Hong Kong Polytechnic University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	290
Start date	1 March 2022
Primary completion	1 October 2023
Estimated completion	30 June 2024

Drugs / interventions tested

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

Conditions studied

• Caregiver Burden — all drugs for Caregiver Burden →

Sponsor

The Hong Kong Polytechnic University

Who can join

18 and older, any sex, with Caregiver Burden. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Kor PPK, Li ML, Kwok DKS, Leung AYM, et al · · 2022 · cited 4× · PMID 35854347 · DOI 10.1186/s40359-022-00876-8
2. The effectiveness of a hybrid mindfulness-based intervention in reducing stress among informal caregivers of people with dementia: a randomized controlled trial.
   Kor PPK, Tsang APL, Lai DLL, Liu JYW. · · 2025 · PMID 41275399 · DOI 10.1093/geront/gnaf281