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
试验速览
- 阶段
- 不适用
- 入组人数
- 290
- 主要终点
- Change in perceived Stress scale of caregivers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcome measurements will be collected by an independent trained assessor (a trained research assistant) who are blinded to the group assignment of the participants
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in perceived Stress scale of caregivers
时间窗: baseline, immediately after the intervention, 6 month- after the intervention
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
次要结局
- Change in positive caregiving experience of caregivers(baseline, immediately after the intervention, 6 month- after the intervention)
- Change in depressive symptoms of caregivers(baseline, immediately after the intervention, 6 month- after the intervention)
- Change in caregiving burden of caregivers(baseline, immediately after the intervention, 6 month- after the intervention)
- Change in dyadic relationship(baseline, immediately after the intervention, 6 month- after the intervention)
- Change in heart rate variability of caregivers(baseline, immediately after the intervention, 6 month- after the intervention)
- Change in neuropsychiatric symptoms of the care recipients(baseline, immediately after the intervention, 6 month- after the intervention)
研究者
Patrick KOR Pui Kin
Dr. Kor Pui Kin Patrick
The Hong Kong Polytechnic University