Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis

Официальное название

Nurse-led Acceptance-based Healthy Lifestyles Program for Community-dwelling Patients With Pneumoconiosis: A Waitlist Pilot Randomized Controlled Trial

Обзор

Symptoms, such as cough and shortness of breath, are common among patients with pneumoconiosis. Depression and anxiety can be elicited by the symptoms, while avoidance of daily activities is believed to reduce trigger of symptoms. The lung function is then declined and the risk of having stroke and heart failure is increased. The objectives of this 2-arm waitlist pilot randomized controlled trial are to test the effects and feasibility of an acceptance-based educational program among patients with pneumoconiosis. 80 participants will be recruited from community centers and randomly assigned to intervention group or waitlist-control group in a ratio of 1:1. The 6-week group-based educational program will be provided to the intervention group first, then the waitlist-control group. The program consists of 4 sessions integrated with acceptance components and care of pneumoconiosis. Their psychological health, healthy lifestyles, and cardiometabolic profiles will be assessed at baseline, week 6, and week 14. Data will be analyzed using a statistical package. The feasibility of the program will be evaluated by interview. The findings of this study can inform the integration of acceptance-based intervention into pneumoconiosis management in Hong Kong, and future study on chronic progressive lung diseases.

Вмешательства

• Другое Acceptance-based healthy lifestyles program (intervention group)
  The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.
• Другое Acceptance-based healthy lifestyles program (control group)
  The acceptance-based healthy lifestyles program consists of 4 biweekly 60-min face-to-face interactive workshops to cover the knowledge of pneumoconiosis, exercise to maintain lung function, health diet, and home safety.

Первичные конечные точки

• Psychological flexibility [Срок оценки: Baseline, week 6, and week 14]

Вторичные конечные точки (6)

• Exercise-related outcome [Срок оценки: Baseline, week 6, and week 14]
• Practice of healthy diet [Срок оценки: Baseline, week 6, and week 14]
• Blood pressure [Срок оценки: Baseline, week 6, and week 14]
• Waist circumference [Срок оценки: Baseline, week 6, and week 14]
• Body weight [Срок оценки: Baseline, week 6, and week 14]
• Glycated hemoglobin (HbA1c) [Срок оценки: Baseline and week 14]

Критерии участия

Критерии включения

• Ethnic Chinese who is able read and speak Chinese.
• Adults aged 18 or over.
• Taking compensation for pneumoconiosis.

Критерии исключения

• Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
• Those who are unable to give written consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Гонконг · 1 центр

• PMAA — Гонконг

Идентификаторы

NCT: NCT06563674 · temp

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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