The Effects of a Hybrid Face-To-Face & Online Mode of Delivering a

Status Not yet recruiting

Clinical 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 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05242614
Study type	Interventional
Source	The Hong Kong Polytechnic University
Contact	Pui Kin Patrick Kor
Phone	2766 5622
Email	patrick.kor@polyu.edu.hk
Status	Not yet recruiting
Phase	N/A
Start date	March 1, 2022
Completion date	June 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05550545` - Infant RSV Infections and Health-related Quality of Life of Families
Recruiting	`NCT06018311` - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads	N/A
Recruiting	`NCT06099197` - I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals	N/A
Not yet recruiting	`NCT05567120` - Pre-Pilot: Problem Adaptation THerapy in Caregivers	N/A
Completed	`NCT00259415` - Telesupport: Evaluation of Professionally Led Support Groups for Caregivers	Phase 1
Active, not recruiting	`NCT05992467` - WECARE: A Behavioral Intervention for Dementia Caregivers	N/A
Completed	`NCT04109209` - Psychological Intervention For Brain Tumor Caregivers	N/A
Recruiting	`NCT05780476` - A Novel VIRTUAL Reality Intervention for CAREgivers of People With Dementia (VirtualCare)	N/A
Completed	`NCT05996718` - Improving Care Through Improv: Promoting Mastery in the Moment	N/A
Recruiting	`NCT06307197` - HAAL: HeAlthy Ageing Eco-system for peopLe With Dementia	N/A
Completed	`NCT05778747` - Feasibility of the Heart to Heart Yoga Program	N/A
Not yet recruiting	`NCT06072274` - Efficacy of VR Educational Program on Empathy and Attitudes Toward Dementia in Caregivers	N/A
Recruiting	`NCT05595850` - A Mindful Community for People With ALS and Their Primary Caregivers	N/A
Completed	`NCT04553679` - Mindfulness After Stroke
Recruiting	`NCT05178966` - Evaluation of Efficiency of One Day Patient/Caregiver Psychoeducation on the Caregiver's Burden	N/A
Recruiting	`NCT05373537` - Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism	N/A
Completed	`NCT06466239` - PNF Method for Those Working in Special Education	N/A
Completed	`NCT05616572` - Online Educational Tool for Caregivers of Pediatric Oncology Patients	N/A
Completed	`NCT05762315` - Transformative Audio Storytelling	N/A
Completed	`NCT05351528` - of Caregiver Family Members for the Disabled in Bukhara

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms