Effectiveness of a Mindfulness and Digital Technology Program for Healthy Aging (MMP-DTLA)

Not Applicable

Not yet recruiting

• Conditions: Mindfulness; Healthy Aging

• Registration Number: NCT07025655
• Lead Sponsor: Chang Gung University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study Start: 2025-06-11
• Study First Submitted QC: 2025-06-15
• Last Update Submitted: 2025-06-15
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. ability to communicate in Mandarin or Taiwanese
2. aged 65 years or older in the community
3. Currently using a mobile phone and the LINE application as a means of communication.

Exclusion Criteria

• Individuals with cognitive impairments
• Unable to communicate verbally

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mindfulness awareness	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	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	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.
Heart rate variability: LF/HF ratio	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	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	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	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.
Cognitive function	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	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.