Clinical trial NCT06619938: Mindfulness-Based Intervention Using Consumer-Grade Wearable Devices with Biofeedback for Family Caregivers of People with Dementia
Official title: Effects of Using a Consumer-Grade Wearable Device with Biofeedback and Brief Mindfulness Training for Stress Reduction in Family Caregivers of People with Dementia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiving Stress
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to investigate the effectiveness of a brief mindfulness training intervention using a consumer-grade wearable device with biofeedback for reducing stress and promoting psychological health in family caregivers of people with dementia.

The intervention includes two weekly sessions, each lasting 90 minutes, of brief mindfulness training. The intervention group will be provided with a wearable device that offers biofeedback, which aims to promote their mindfulness practice and help the caregivers cultivate a mindful attitude in their daily activities, leading to stress reduction. Participants in the intervention group will attend a 30-minute briefing session to learn how to use the wearable device and understand the parameters displayed on the device. The caregivers will be instructed to practice mindfulness for 30 minutes every day over the course of eight weeks.

Participants will be randomly assigned to receive either the mindfulness intervention combined with biofeedback or the mindfulness intervention alone. Evaluations will be conducted at three time-points: baseline (0 weeks), mid-intervention (4 weeks), and post-intervention (8 weeks). Both groups will complete the same assessments at each time-point.

Detailed description: Family caregivers of people with dementia (PWD) face significant challenges in managing various caregiving tasks and addressing behavioral issues exhibited by their care recipients. The burden of caregiving and uncertainty about disease progression can lead to high levels of stress among these caregivers. Providing community resources and support for PWD caregivers, particularly to reduce caregiving stress, is crucial and highly recommended. Mindfulness training has been identified as an effective intervention for stress reduction in PWD caregivers. However, maintaining a regular mindfulness practice is essential for achieving sustainable stress reduction, and long-term adherence to self-practice remains a challenge for family caregivers. To help maintain their mindfulness practice, providing participants with visualized improvement via biofeedback may be beneficial.

Biofeedback, a self-regulation technique that helps individuals voluntarily control their automatic body functions, has shown promise in stress reduction. By measuring physiological parameters such as respiratory rate (RR), heart rate (HR), heart rate variability (HRV), and electrodermal activity (EDA), individuals can gain greater awareness of their body\&#39;s functioning and recognize health problems, motivating them to modify their lifestyle and reduce stress. Previous studies on biofeedback training have primarily been conducted in laboratory or clinical settings, requiring the presence of a therapist and using large, expensive medical monitors. However, the recent proliferation of consumer-grade wearable devices, such as the Apple Watch and Fitbit, offers a more accessible, affordable, and user-friendly alternative. These devices provide self-directed learning and biofeedback, including RR, HR, HRV, EDA, and sleep patterns. Unlike medical-grade monitors, consumer-grade wearables often present health parameters in simple figures and graphics, making it easier for users to understand their stress levels. Moreover, validation studies have demonstrated high agreement between consumer-grade and medical-grade devices for various parameters in diverse populations, including patients with chronic obstructive pulmonary disease, pediatric patients, intensive care unit patients, and cardiac rehabilitation patients. Additionally, these lightweight, waterproof devices can continuously measure and provide information about daily stress patterns, activities, and the effects of relaxation skills and mindfulness practice.

This study aims to investigate the effectiveness of a brief mindfulness-based intervention combined with biofeedback using consumer-grade wearable devices in reducing stress among family caregivers of PWD. The study will also examine secondary outcomes, including heart rate variability, depressive symptoms, anxiety symptoms, trait mindfulness, and neuropsychiatric symptoms in care recipients.

The target population for this study will be family caregivers of PWD. They will be recruited from elderly centers through collaborations with local non-governmental organizations. Interested participants will be assessed for eligibility. After interested and eligible participants provide their consent, they will be randomly assigned to receive either the mindfulness intervention combined with biofeedback or the mindfulness intervention alone.

The intervention includes two weekly sessions (90 minutes each) of brief mindfulness training. After the first session of mindfulness training, the intervention group will be given a wearable device with biofeedback on RR, HR, HRV, EDA, and sleeping patterns, which aims to promote their mindfulness practice and help the caregivers cultivate a mindful attitude in their daily activities, leading to stress reduction. A 30-minute briefing session will be provided for the caregivers to learn how to use the wearable devices and understand the parameters on the device. In this study, the Fitbit Sense with the Fitbit apps will be used. The caregivers can (1) receive real-time RR, HR, HRV, and EDA on the wearable device and review the trends on their smartphone; (2) receive a daily reminder for mindfulness practice from the wearable device; (3) listen to audio coaching for mindfulness practice from the Fitbit apps; (4) set a personal goal (e.g., daily practice of 30 minutes) in the Fitbit apps; (5) track and record their duration of practice; (6) rate and review their perceived daily stress level; and (7) review their duration and quality of sleep. After the second session of brief mindfulness training, the caregivers will be instructed to practice mindfulness for 30 minutes every day over the course of eight weeks.

The control group will receive two weekly sessions of brief mindfulness training, the same as the intervention group. After the first brief mindfulness training, the control group will receive a 30-minute briefing session on goal setting for mindfulness practice. Each caregiver will be asked to develop an action plan for continuous mindfulness practice. A mindfulness therapist will also discuss the challenges and solutions for developing a habit of mindfulness practice with the caregivers in the second session. All caregivers in both the intervention and control groups will be advised to practice mindfulness daily for 30 minutes.

The outcome measures assessed include perceived caregiving stress (primary), heart rate variability, depressive symptoms, anxiety symptoms, trait mindfulness, and neuropsychiatric symptoms. Feasibility measures include eligibility and enrollment, attendance rate, adherence rate, and retention rate. Evaluations will be conducted at baseline (0 weeks), mid-intervention (4 weeks), and post-intervention (8 weeks). Both groups will complete the same assessments at the same time points.

Eligibility criteria: Inclusion Criteria:

* Family caregivers of an individual who has been residing in the community with a confirmed medical diagnosis of any type of dementia (from NGO record or the care-recipients\&#39; medical record);
* Providing care for at least 4 hours or more per week;
* Able to speak Cantonese (for understanding all teaching materials and instructions).

Exclusion Criteria:

* Practicing or having recently learned meditation, mindfulness activities, and/or relaxation training in the last 6 months;
* Regularly using wearable devices;
* Diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression in an acute phase.

Primary outcomes:
measure: Perceived Caregiving Stress in the Family Caregiver
timeFrame: 8 Weeks
Secondary outcomes:
measure: Depressive Symptoms in the Family Caregiver
timeFrame: 8 Weeks
measure: Heart Rate Variability (HRV) in the Family Caregiver
timeFrame: 8 Weeks
measure: Anxiety in the Family Caregiver
timeFrame: 8 Weeks
measure: Trait Mindfulness in the Family Caregiver
timeFrame: 8 Weeks
measure: Neuropsychiatric Syndromes in the Care Recipient
timeFrame: 8 Weeks
measure: Feasibility of Eligibility and Enrollment
timeFrame: 8 Weeks
measure: Feasibility of Attendance Rate
timeFrame: 8 Weeks
measure: Feasibility of Adherence to Wearing the Wearable Device
timeFrame: 8 Weeks
measure: Feasibility of Retention Rate
timeFrame: 8 Weeks
Other outcomes:
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