Clinical trial NCT06563674: Acceptance-based Healthy Lifestyles Program for Patients With Pneumoconiosis
Official title: Nurse-led Acceptance-based Healthy Lifestyles Program for Community-dwelling Patients With Pneumoconiosis: A Waitlist Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumoconiosis
Healthy Lifestyle
Keywords: Pneumoconiosis
Healthy Lifestyle
Acceptance-based
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A 2-arm waitlist pilot randomized controlled trial will be adopted. After baseline data collection, participants in the intervention group will receive the health program for 6 weeks. On the other hand, participants in the waitlist-control group will receive the same health program week 8 and week 14.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Psychological flexibility
timeFrame: Baseline, week 6, and week 14
Secondary outcomes:
measure: Exercise-related outcome
timeFrame: Baseline, week 6, and week 14
measure: Practice of healthy diet
timeFrame: Baseline, week 6, and week 14
measure: Blood pressure
timeFrame: Baseline, week 6, and week 14
measure: Waist circumference
timeFrame: Baseline, week 6, and week 14
measure: Body weight
timeFrame: Baseline, week 6, and week 14
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline and week 14
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: PMAA
Study officials:
References: