Development and Evaluation of a Culturally Adapted Snacktivity™ Intervention to Enhance Cognition and Self-Care in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 210
- 主要终点
- Global cognition
研究概览
简要总结
This clinical trial aims to evaluate whether a culturally adapted Snacktivity™ program can improve cognitive function and self-care abilities in patients with Chronic Obstructive Pulmonary Disease (COPD) in Hong Kong.
The main questions it aims to answer are:
- Does the Snacktivity™ program improve the cognitive function of participants (including both global cognition and targeted subdomains)?
- Does the program improve participants' self-care abilities?
The study consists of three sequential phases:
Phase 1 (Co-design workshops): Co-design workshops will be conducted with COPD patients, healthcare professionals (nurses, physical therapists, occupational therapists), and family caregivers to culturally adapt the Snacktivity™ program for Hong Kong COPD patients.
Phase 2 (Feasibility Pilot RCT): The adapted program will be tested in a small-scale pilot study to assess its feasibility and short-term clinical effects.
Phase 3 (Full-scale RCT): A full-scale randomised controlled trial will be conducted to evaluate the program's efficacy on the primary and secondary outcomes.
Participants in the intervention group will be asked to:
Participate in the culturally adapted Snacktivity™ program that integrates short, manageable "snacks" of physical activity into daily routines.
Wear an activity tracker to monitor physical activity levels. Complete questionnaires at multiple time points assessing cognitive function, self-care abilities, physical activity levels, self-efficacy, exercise capacity, quality of life, anxiety, and depression.
Researchers will compare the intervention group to an attention control group (receiving usual care with health education) to see if the Snacktivity™ program leads to greater improvements in these outcomes.
详细描述
1. Background and Research Gaps: Chronic Obstructive Pulmonary Disease (COPD) is a severe global public health issue. In Hong Kong, COPD remains the second most common cause of respiratory hospitalisation, and 56% of COPD patients experience cognitive impairment (CI), which profoundly impacts patients' self-care abilities and quality of life. Despite a robust theoretical foundation, Snacktivity™ has not yet been validated for patients with COPD, and no randomised controlled trials have confirmed its efficacy in enhancing cognitive function and self-care abilities in this population. Two critical research gaps must be addressed: (1) the suitability of its current activity templates for COPD patients, and (2) the feasibility of its implementation in home and workplace settings. Nurses, physical therapists, occupational therapists, and caregivers offer complementary insights into practical challenges, patient-specific barriers, treatment adherence, and resource allocation requirements essential for tailoring the program to Hong Kong's contextual needs.
2 Study Objectives:
- To explore the feasibility, acceptability, motivating factors, perceived barriers, and preferred formats of the culturally adapted Snacktivity™ program among COPD patients in Hong Kong, and to investigate stakeholders' perspectives, recommendations, and concerns regarding its implementation.
- To examine the short-term and long-term effects of the culturally adapted Snacktivity™ program on patients' cognitive function and self-care abilities (primary outcomes), as well as on physical activity levels, self-efficacy, exercise capacity, health-related quality of life, anxiety, and depression (secondary outcomes).
- To explore the overall efficacy and sustainable implementability of the culturally adapted Snacktivity™ program for COPD patients in Hong Kong.
3 Study Design: This is a three-phase sequential study.
- Phase 1 (Co-design): Co-design workshops will be conducted with COPD patients (n=15), multidisciplinary healthcare professionals (nurses=6, physical therapists=6, occupational therapists=9), and family caregivers (n=6). The aim is to culturally adapt the Snacktivity™ program for Hong Kong COPD patients by gathering diverse perspectives on practical challenges, patient-specific barriers, treatment adherence, and preferred intervention formats. The co-design process follows a four-stage approach: Stage 1 (patient-only workshop), Stage 2 (multi-stakeholder workshop), Stage 3 (WhatsApp asynchronous feedback), and Stage 4 (patient final validation workshop).
- Phase 2 (Feasibility Pilot RCT): A small-scale pilot randomised controlled trial will be conducted with 50 COPD patients (25 per group) to test the adapted program's feasibility and short-term clinical effects. The intervention lasts 12 weeks, with assessments at baseline and immediately post-intervention. Feasibility outcomes include recruitment and retention rates, intervention adherence, and dropout rates. This phase primarily evaluates feasibility outcomes to inform the design of the subsequent full-scale trial. Clinical outcomes measured in this phase include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study is single-blinded. The outcomes assessor is masked to group allocation throughout the study. Participants are aware of their group assignment, and intervention providers (researchers delivering the Snacktivity™ program or attention control sessions) are not masked due to the nature of the behavioral intervention.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Confirmed diagnosis of COPD in accordance with the 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guideline, with a post-bronchodilator ratio of FEV₁/FVC < 70%;
- •Aged ≥ 60 years;
- •Clinically stable condition;
- •Score at or below the age- and education-adjusted cutoff (16th percentile) on the Hong Kong Montreal Cognitive Assessment (HK-MoCA) 5-minute Protocol, indicating mild cognitive impairment;
- •No exercise contraindications;
- •No active wrist skin conditions that would prevent wearing an activity tracker (Phase 2 & 3);
- •Willingness to wear an activity tracker during the intervention (Phase 2 & 3);
- •Possession of a smartphone capable of receiving instant messages (Phase 2 & 3);
- •Proficiency in Cantonese or Mandarin;
- •Willingness to provide written informed consent and commitment to trial completion.
排除标准
- •Receipt of oxygen therapy for ≥ 15 hours per day or requirement for mechanical ventilation;
- •History of brain injury or stroke;
- •Presence of severe comorbidities including coronary artery disease, severe hepatic or renal dysfunction;
- •Diagnosis of psychiatric disorders, deafness, severely limited physical mobility, or inability to cooperate with trial interventions;
- •For Phase 2 and Phase 3: Use of medications documented to impact cognitive function.
研究组 & 干预措施
Snacktivity™ Intervention Group
Participants in this arm receive the culturally adapted Snacktivity™ program. The intervention integrates short, manageable "snacks" of moderate-intensity physical activity (2-5 minutes per session, 5-6 sessions per day) into daily routines to accumulate at least 150 minutes of physical activity per week. Participants wear a Garmin activity tracker to objectively monitor physical activity levels. The intervention lasts 12 weeks and includes a 30-minute pre-intervention guidance session, a self-guided manual with illustrated activity templates, and structured follow-up support consisting of one weekly 30-minute in-depth session and two weekly 10-15-minute brief sessions. During each follow-up session, researchers recommend specific activity templates based on the participant's reported daily routine and co-develop a personalized 2-3 day activity schedule, which is documented in the participant's training manual.
干预措施: Snacktivity™ Intervention (Behavioral)
Attention Control Group
Participants in this arm receive usual care plus additional attention to control for the non-specific effects of time and contact. They attend a single 60-minute group health education session on general lifestyle modification, based on the Hospital Authority's "COPD Self-Management Guide" (3rd Edition), with no physical activity advice or recommendations provided. During the 12-week intervention period, they receive the same two-tier follow-up schedule as the intervention group (one weekly 30-minute session and two weekly 10-15-minute brief sessions), focusing on general lifestyle assessment (e.g., sleep quality, nutrition, mood) and encouragement to maintain healthy behaviors, without any physical activity planning or template selection.
干预措施: attention control (Behavioral)
结局指标
主要结局
Global cognition
时间窗: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)
Global cognition will be assessed using the HK-MoCA. Developed originally by Dr. Ziad S. Nasreddine, the HK-MoCA is a validated and sensitive tool for global cognitive screening, which is specifically adapted to evaluate the cognitive status of patients in the Hong Kong region.
Memory
时间窗: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)
We employed the Huashan version of the Auditory Verbal Learning Test (AVLT) adapted by Guo et al., to assess participants' memory. The test materials consist of three categories of nouns (clothing, occupations, and flowers), each with four related words, for a total of 12 target words. The test procedures and scoring methods are as follows: First, an immediate recall task is conducted. Participants are required to recall the 12 target words immediately after the tester reads them aloud, and this process is repeate times. The total score of immediate recall is the sum of the number of correctly recalled words in the three consecutive tests, with a maximum score of 36. Subsequently, delayed recall tasks are performed after 5 minutes (short-term delayed recall) and 20 minutes (long-term delayed recall), requiring participants to recall the target words. Meanwhile, a cued recall task is added, which requires participants to recall the words by category. The individual total scores for
Language
时间窗: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)
The Animal Fluency Test (AFT) is used to assess the language function of the participants. The specific requirements are: the participants need to name as many different animals as possible within 1 minute, and the number of animals listed is used as the evaluation indicator. The results are judged based on the educational level: for those with junior high school education or below, if the number is less than 12; for those with high school education, if the number is less than 12; for those with college education or above, if the number is less than 14, all of which are judged as abnormal results. The lower the score of this test, the worse the language function of the participant.
Executive function
时间窗: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)
The Shape Trails Test (STT), a subtest of the Halstead-Reitan Neuropsychological Test Battery, is used to assess the executive function of participants.
Attention
时间窗: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)
The Digit Span Test (DST) is employed to assess participants' attentional functions. The specific procedure was as follows: the examiner recited a series of digits, requiring participants to reproduce the digit sequences in both forward and backwards order. In the forward span task, the examiner presented digit sequences at a rate of 1 digit per second, starting with 3-digit sequences and incrementing by 1 digit each time up to 12-digit sequences. Each digit length category contained 2 test items. If the participant failed the first trial, the second trial was administered; the testing for that digit length was terminated only when both trials were failed. If the participant succeeded in the first trial, they proceeded to the next digit length category. The backward span task followed the same operational protocol as the forward span task, except that participants were required to reproduce the digits in reverse order. For the scoring rules, each correctly reproduced digit sequence
Self-Care Abilities
时间窗: Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only)
Self-care abilities will be assessed using the Community COPD Self-Management Scale, a 39-item scale covering three domains: disease symptom management, lifestyle management, and psychosocial management. Total scores range from 39 to 195, with higher scores indicating better self-care abilities.
次要结局
- Physical Activity Levels(Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only))
- Self-Efficacy(Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only))
- Exercise Capacity(Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only))
- Health-Related Quality of Life(Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only))
- Anxiety Symptoms(Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only))
- Depression Symptoms(Baseline, immediately post-intervention (Week 12), and 3 months post-intervention (Phase 3 only))
研究者
Dr. Yi-Nam Suen
Assistant Professor
The University of Hong Kong