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Clinical Trials/NCT05242614
NCT05242614
Unknown
Not Applicable

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 University0 sites290 target enrollmentMarch 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Caregiver Burden
Sponsor
The Hong Kong Polytechnic University
Enrollment
290
Primary Endpoint
Change in perceived Stress scale of caregivers
Last Updated
4 years ago

Overview

Brief 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 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
June 30, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick KOR Pui Kin

Dr. Kor Pui Kin Patrick

The Hong Kong Polytechnic University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in perceived Stress scale of caregivers

Time Frame: 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

Secondary Outcomes

  • 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)

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