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

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Caregiver Burden

Treatments: Behavioral: The Hybrid Mindfulness-based Dementia caregiving program (MBDCP); Behavioral: Psychoeducation educational program

Study type: Interventional

Funder types: Other

Identifiers

NCT05242614

HSEARS20210709005

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

A hybrid Mindfulness-based Dementia Caregiving Program (MBDCP)

Experimental group

Description:

Participants 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.

Treatment:

Behavioral: The Hybrid Mindfulness-based Dementia caregiving program (MBDCP)

Control group

Active Comparator group

Description:

The 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.

Treatment:

Behavioral: Psychoeducation educational program