NCT07702994Toborzás még nem indult
Effects of Adapted Snacktivity™ Intervention on Cognition and Self-Care in COPD Patients
Development and Evaluation of a Culturally Adapted Snacktivity™ Intervention to Enhance Cognition and Self-Care in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 14.
Rövid összefoglaló (regiszter, angolul)
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: 1. Does the Snacktivity™ program improve the cognitive function of participants (including both global cognition and targeted subdomains)? 2. 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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 210 (tervezett)
- Első benyújtás
- 2026. jún. 30.
- Kezdés
- 2026. júl. 15.
- Elsődleges befejezés
- 2028. jún. 30.
- Fő szponzor
- The University of Hong Kong
- Betegségek
- Krónikus obstruktív tüdőbetegség (COPD)
- NCT-szám
- NCT07702994
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 210
- 2026. júl. 15. és az elsődleges befejezés (2028. jún. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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A regiszterben nem jelölt feltételek
- 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.
- Exclusion Criteria
- 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.
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