The Effectiveness of a Multifaceted Mindfulness Program Integrated With Digital Technology-Assisted Learning on Healthy Aging in Community-Dwelling Older Adults: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- mindfulness awareness
研究概览
简要总结
This study aims to evaluate the effectiveness of a mindfulness program integrated with digital technology-assisted learning on healthy aging among community-dwelling older adults. In a randomized controlled trial, 100 participants will be randomly assigned to either an experimental or a control group. The experimental group will receive a ten-week mindfulness program supported by digital tools such as educational videos and LINE Bot messaging. Primary outcomes include mindfulness awareness, physical activity, heart rate variability, cognitive function, sleep quality, perception of aging, and healthy aging perspectives. Additionally, qualitative interviews will be conducted with 10 experimental group participants to explore their intervention experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ability to communicate in Mandarin or Taiwanese
- •aged 65 years or older in the community
- •Currently using a mobile phone and the LINE application as a means of communication.
排除标准
- •Individuals with cognitive impairments
- •Unable to communicate verbally
研究组 & 干预措施
Mindfulness
Ten-week mindfulness programs supported by digital technology-assisted teaching materials
干预措施: Multifaceted Mindfulness Program (Behavioral)
Control
No intervention
干预措施: Placebo (Behavioral)
结局指标
主要结局
mindfulness awareness
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The Five Facet Mindfulness Questionnaire (FFMQ) will be used. Items are rated on a 5-point Likert scale ranging from 5 (almost always) to 1 (never), with higher scores indicating greater frequency. Certain items are reverse-coded, and total scores are computed after adjusting for these items. A higher total score reflects a greater level of mindfulness.
Physical activity: PASE-C
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The PASE-C encompasses domains including total physical activity, leisure activities, household activities, and occupational activities. Higher scores indicate greater levels of physical activity.
Physical activity: SPPB
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The SPPB comprises three components: balance tests, gait speed tests, and chair stand tests. A total score ranging from 0 to 9 indicates mobility impairment, whereas a score between 10 and 12 reflects normal mobility function.
Cognitive function
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function among community-dwelling older adults. The total score ranges from 0 to 30, with higher scores indicating better overall cognitive functioning. A score of 26 or above is generally considered within the normal range.
Heart rate variability: SDNN
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. The standard deviation of normal-to-normal intervals (SDNN) reflects the variability in RR intervals from electrocardiogram recordings, with higher SDNN values indicating greater heart rate variability.
Heart rate variability: LF/HF ratio
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
Heart rate variability (HRV) was assessed using a monitoring device to evaluate autonomic nervous system activity. Sympathetic and parasympathetic activity were assessed through frequency-domain measures, including low-frequency (LF) and high-frequency (HF) components. The LF/HF ratio was calculated to evaluate the balance of autonomic nervous system activity.
Sleep quality
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The study utilized the Pittsburgh Sleep Quality Index (PSQI) to measure sleep quality. The Pittsburgh Sleep Quality Index (PSQI) yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score greater than 5 is indicative of clinically significant sleep disturbance.
Perception of ageing
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The perception of ageing was measured using the Brief Aging Perceptions Questionnaire (B-APQ). A 5-point Likert scale was used for scoring, with 1 indicating 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores reflect more positive perceptions of aging.
Healthy ageing perspectives
时间窗: We will collect four times of data: 1. Baseline 2. The fourth week 3. Up to 10 weeks 4. After completing the study for one month
The Healthy Aging Perspectives Questionnaire (HAPQ) will be used. This questionnaire adopts a 5-point Likert scale, where 1 indicates 'strongly disagree,' 2 'disagree,' 3 'neutral,' 4 'agree,' and 5 'strongly agree.' Higher scores indicate more positive perspective of healthy aging.
次要结局
未报告次要终点
研究者
Yu-Rung Wang
Assistant Professor
Chang Gung University of Science and Technology