Nurse-led Acceptance-based Healthy Lifestyles Program for Community-dwelling Patients With Pneumoconiosis: A Waitlist Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Psychological flexibility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The baseline data will be collected by research assistant (RA)1 before randomization, while the follow-ups data will be collected by RA2. The participant's group allocation is masked to the outcome assessors. But the participants know their group allocation after randomization because of the nature of the intervention. Different dates will be planned for different groups for all follow-ups respectively to avoid contamination of the subjects and blinding to the outcome assessors as far as possible
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ethnic Chinese who is able read and speak Chinese.
- •Adults aged 18 or over.
- •Taking compensation for pneumoconiosis.
排除标准
- •Those who have mental, visual, hearing, or cognitive impairments with regular medical follow-ups and treatment.
- •Those who are unable to give written consent.
结局指标
主要结局
Psychological flexibility
时间窗: Baseline, week 6, and week 14
Measured by Acceptance and Action Questionnaire-II Chinese version. It is a 7-point Likert scale with 7 items. The score ranges from 7 to 49 and a higher total score indicates less flexibility.
次要结局
- Exercise-related outcome(Baseline, week 6, and week 14)
- Blood pressure(Baseline, week 6, and week 14)
- Practice of healthy diet(Baseline, week 6, and week 14)
- Body weight(Baseline, week 6, and week 14)
- Waist circumference(Baseline, week 6, and week 14)
- Glycated hemoglobin (HbA1c)(Baseline and week 14)
研究者
Hon Lon Tam
Research Assistant Professor
Chinese University of Hong Kong